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President Issues Sanctions to Support Stability in Ukraine
Today, March 6, 2014, President Obama signed a new Executive Order in response to the threats Ukraine is facing to its peace and stability. The Executive Order addresses attempts to assert governmental authority in the Crimean region without the approval of the Ukrainian government and authorizes sanctions against any individual or entity that the Secretary of the Treasury and the Secretary of State determine:
Is responsible for, or complicit in, actions or policies that undermine democratic processes or institutions in Ukraine;
Threatens the peace, security, stability, sovereignty, or territorial integrity of Ukraine;
Is involved in the misappropriation of state assets of Ukraine; or
Has asserted governmental authority over any part or region of Ukraine without the authorization of the Government of Ukraine.
After an individual or entity is identified by Treasury and State, the Executive Order blocks all of the individual or entity’s property and interest in property in the United States … Read More »
New Reprint Guidance Maintains Bipartisan Status Quo
On February 28, 2014, the FDA issued its most recent unofficial guidance on distribution by manufacturers of research concerning off-label uses.[1] With minor textual revisions, this new Guidance essentially restates the safe harbors acknowledged in FDA’s unofficial 2009 “Good Reprint Practices” Guidance[2], and expands them to medical reference texts and clinical practice guidelines. Under the 2014 Guidance, drug and device manufacturers can engage in some forms of distribution of peer-reviewed research about off-label use of their products without fear this will be used as evidence of misbranding. In not backtracking from the 2009 reprint reforms, but rather expanding them to embrace other forms of communication, the 2014 Guidance represents continued evolution of FDA’s position on speech concerning off-label use.
This evolution has been tortuous. FDA’s initial position, in the early 1990s, was that manufacturers were prohibited from providing doctors with any unsolicited information … Read More »
High Court Should Reverse 4th Circ.’s Flawed FCA Ruling
The U.S. Supreme Court is currently deciding whether to review the Fourth Circuit’s decision in United States ex rel. Carter v. Halliburton Co., 710 F.3d 171 (4th Cir. 2013), holding that the Wartime Suspension of Limitations Act suspended the statute of limitations for civil False Claims Act cases.
In Carter, a former employee filed a whistleblower action under the qui tam provisions of the FCA, alleging that, in early 2005, the defendants submitted false claims to the United States military for water purification services provided during the Iraq War. The United States declined to intervene and the former employee has litigated the action on behalf of the government, as the qui tam provisions permit.
The district court dismissed these claims as barred by the FCA’s six-year statute of limitations. The Fourth Circuit reversed. It held that the October 2002 Congressional authorization for … Read More »
FDA Announces Start of Voluntary Supply Chain Pilot Program
In a February 18, 2014, news release, the U.S. Food and Drug Administration (FDA) announced the launch of its Secure Supply Chain Pilot Program (SSCPP) and the names of the 13 companies selected to participate in the program. The FDA originally proposed the pilot in 2009 and officially announced the start of the program and the selection criteria for participation in August 2013. The pilot is scheduled to run for two years, until February 2016.
As background, the FDA designed the program with the intent to reduce scrutiny of low-risk imports so that it may increase its attention on less trustworthy foreign-made medicine. It hopes to create incentives for manufacturers to adopt best practices for supply-chain safety so that it can enhance the quality and safety of all imported drugs. Its aim is to stop the importation of contaminated, misbranded or … Read More »
Final Rule Expands Access to Laboratory Records
On February 6, 2014, the Department of Health and Human Services (HHS) released a Final Rule that amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The Final Rule provides that, by October 6, 2014, laboratories qualifying as covered entities under HIPAA must comply with an individual’s request for access to certain protected health information, including laboratory test results concerning that individual that are part of the laboratory’s designated record set.
Previously, laboratories that were either subject to CLIA or CLIA-exempt and that received such requests were not required to provide record access to an individual. Rather, laboratories were allowed to disclose results only to specific individuals authorized under state law to order or receive test results – generally a health care provider. HHS has made clear that its goal in … Read More »
Final FDA Guidance Clarifies “Dear Doctor” Letter Requirements
On January 23, 2014, the United States Food and Drug Administration (“FDA”) released a final guidance entitled Dear Health Care Provider Letters: Improving Communication of Important Safety Information, 75 Fed. Reg. 3827 (“Final Guidance”), available here, in which the Agency provides recommendations regarding when to issue a Dear Health Care Provider (“DHCP”) letter, what information to include in a letter, how to organize the information, and how to format letters for ease of access by health care providers.
Emphasizing effective and prompt communication goals, the FDA encourages pharmaceutical and biologics manufacturers to consult with the Agency “to ensure that the letter clearly and accurately reflects both the manufacturer’s and FDA’s understanding of the issues and the action required,” including a determination of the following:
Whether a DHCP letter is needed to convey new or important information;
How to format and present the new … Read More »
FDA Draft Guidance on Interactive Promotional Media for Drugs
The Draft Guidance
On January 13, the FDA issued draft guidance on the requirements for postmarketing submissions of interactive promotional media for drugs and biologics. The draft guidance provides valuable clarification of when the FDA will hold a company responsible for promotional content on social media.
The draft guidance defines “interactive promotional media” as “modern tools and technologies that often allow for real-time communications and interactions” (including blogs, microblogs, social networking sites, online communications, and live podcasts) used to promote a drug. The draft guidance states that product communications will be subject to postmarketing submission requirements if carried out directly by or on behalf of a manufacturer, packer, or distributer (a “firm”). A firm is accountable for product communications if the firm, or someone acting on its behalf, is “influencing or controlling the product promotional activity or communication in whole or part.” … Read More »
Louisiana Supreme Court Strikes Down Expansive Interpretation of State Medicaid Fraud Statute
In a decision that has important ramifications for the life sciences industry, on January 28, 2013, in Caldwell ex rel State of Louisiana v. Janssen Pharmaceutical, Inc., (No. 2012-C-2447, No. 2012-C-2466), the Supreme Court of Louisiana, by a 4–3 vote, reversed a $330 million trial court award against Janssen Pharmaceutica, Inc., and entered final judgment in Janssen’s favor. Under the theory of liability that had been pursued by Louisiana at trial, virtually any public statement about any product that might be subject to Medicaid reimbursement could be subject to civil penalties totaling hundreds of millions of dollars—on a state-by-state basis—even if the statement was not made as part of a claim for reimbursement and there was no proof that the providers who wrote prescriptions for it did so for any reason other than a medical determination the product was the more … Read More »
FTC Amendments to Premerger Notification Rules: The Who, What & Why
On November 6, 2013, the Federal Trade Commission released final amendments to the Hart-Scott-Rodino Premerger Notification Rules to clarify when a transaction involving the transfer of rights to all or part of a pharmaceutical (including biologics) patent is reportable under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the “HSR Act”).
The final rule, which is the same as the proposed rule circulated a year ago for public comment, codifies an “all commercially significant rights” test to determine whether a transfer of rights has occurred in an exclusive patent license agreement. Under that rule, if a patent licensor transfers all commercially significant rights to the patent, the transaction may be reportable. The final rule states that if “limited manufacturing rights” are retained by the licensor, then the transaction may also be reportable under the Act.
The final rule, which takes effect on December 16, 2013, is available … Read More »
The Debate Over Mobile Health Software Regulation
On November 19th, the House Energy and Commerce Subcommittee on Health held a hearing to examine the federal regulation of mobile medical applications (mobile apps) and other health software. Earlier, on September 25, the FDA released guidance on this issue, describing how it intends to regulate mobile medical apps pursuant to its authority under the Federal Food, Drug and Cosmetic Act to regulate “medical devices.” Lawmakers, however, are concerned with the expanse of the FDA’s authority and scope of the FDA’s interpretation of what constitutes a “medical device.” Accordingly, some legislators are pursuing new legislation to solidify a standard for medical software and restrict the FDA’s authority. The recent Subcommittee hearing focused on whether mobile health software should be regulated as a medical device and whether Congress or the FDA should set the rules.
The FDA’s View
While concern has arisen that … Read More »
23 Skidoo – Genomes, Gamesmanship and the First Amendment
On November 22, 2013, the Inquisition collided with the Internet. On that date, the Food and Drug Administration issued a Warning Letter threatening 23andMe, Inc. with seizure of product, injunctions and civil monetary penalties based on allegations that 23andMe – which provides customers with information about their personal genomes – is selling misbranded and adulterated medical devices. In plain terms, FDA has sought to restrict dissemination of this information for no other reason than an undocumented fear people might misuse it. If FDA follows through on its threats of regulatory action, this dispute could provide the forum for defining the First Amendment limits of the FDA’s power to regulate public health by restricting dissemination of information.
By way of brief background, for $99, 23andMe provides a receptacle for a saliva sample and a mailer. Upon receipt, 23andMe extracts selected genetic information … Read More »
FDA’s Warning Letter to 23andMe: Ethical and Legal Issues
The FDA’s warning letter to 23andMe, the maker of mail-order genetic tests, highlights the challenging legal and ethical issues posed by such products. While the FDA’s letter focuses on charges that (a) 23andMe’s DNA collection kit is an adulterated Class III medical device because it has not obtained prior regulatory clearance, and (b) the product is misbranded because 23andMe has failed to provide adequate evidence that its product provides accurate results, the situation raises additional questions.
For example, should direct-to-consumer medical genetic testing (DTCMGT) be regulated as “the practice of medicine”? To date, DTCMGT, which takes place outside of the traditional medical setting, has not been subjected to state law regulatory requirements applicable to “the practice of medicine” imposed on medical providers. Such requirements could assure involvement of a genetics professional in the testing, which could reduce risks of inadequate informed … Read More »
FDA Final Guidance on Mobile Medical Applications
Summary
On September 23, 2013, the FDA issued a guidance (“Final Guidance”) explaining how medical device regulations will be applied to medical mobile applications (MMAs).[1] The Final Guidance provides mobile application manufacturers with recommendations on how to comply with the regulatory and statutory requirements governing medical devices. The Guidance indicates that the FDA intends to limit its enforcement authority to only those mobile applications that operate as medical devices and pose a significant risk to patients if they fail to function as intended.
The Final Guidance outlines three categories of mobile applications (mobile apps) generally: (1) mobile apps that are not medical devices as defined under the Federal Food, Drug, and Cosmetic Act and are therefore not subject to FDA regulation; (2) mobile apps that may meet the definition of a medical device but over which the FDA intends to exercise enforcement … Read More »
Impact of Healthcare Mobile Apps on Treatment
The use of healthcare applications on mobile devices continues to have a growing impact on medical treatment as consumers are using mobile devices to take more responsibility for their own care. Recently, digital marketing agency Digitas Health compiled data on the impact of mobile health care applications in “CONSUMER MOBILE HEALTH IMPACT ASSESSMENT: How the Use of Mobile Impacts Disease Treatment and Therapy.” Digitas’ findings provide useful insight for marketers and health and wellness brands looking for new ways to effectively reach patients and their physicians with information on available treatment options.
Mobile devices are becoming a continuous part of the healthcare process and are being used by patients in both waiting rooms and exam rooms. In fact, one in three patients surveyed claimed that either they or their physician used a mobile device in the exam room. The study shows … Read More »
Photocopiers – A Recurring Data Security Risk
In a case that illustrates the data privacy risks associated with modern copiers, the United States Department of Health and Human Resources (HHS) has announced a $1,215,780 settlement with Affinity Health Plan, Inc. (Affinity), arising from an investigation of potential violations of the HIPAA Privacy and Security Rules.
This matter started when Affinity was advised by CBS Evening News that CBS had purchased a photocopier previously leased by Affinity. CBS explained that the copier’s hard drive contained confidential medical information relating to Affinity patients. As a result, on August 15, 2010, Affinity self-reported a breach with the HHS’ Office for Civil Rights (OCR). Affinity estimated that the medical records of approximately 344,000 persons may have been affected by this breach. Moreover, Affinity apparently had returned multiple photocopiers to office equipment vendors in the past without erasing the data contained upon the … Read More »
FDA and CBP to Begin New Pilot Programs
Both the Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) are expected to begin pilot programs to give additional benefits to importers who have secured their supply chains and internal controls this September. On August 20, 2013, the FDA announced it will begin accepting applications to participate in its Secure Supply Chain Pilot Program (SSCPP) which will run for two years, from February 2014 through February 2016. CBP has not yet officially announced, but is expected to announce within the next month, that it will begin a test pilot for its Trusted Trader Program.
Through the SSCPP, the FDA hopes to prevent the importation of adulterated, misbranded, or unapproved drugs by allowing the Agency to focus its resources on imported drugs that fall outside the program and may pose risks. The FDA plans to increase the rate at … Read More »
Ethical Issues Surrounding Noncompliance in Organ Donation
Within a few months of the controversial lung donation to a child who was placed on the adult organ donation waiting list by way of a judge’s ruling, the media has been buzzing about yet another controversial case.
15-year old Anthony Stokes received a heart transplant at Children’s Healthcare of Atlanta on August 20. Anthony had originally been denied a spot on the heart transplant list due to his noncompliance, one of the medical center’s contraindications for being listed for a heart transplant. Apparently, a doctor told Anthony’s family that his “history of noncompliance” related to his low grades and time spend in juvenile detention. A week later, Anthony’s doctors and the hospital reversed their decision, giving him top priority on the transplant list.
Anthony began having chest pain this summer, which led to his admission to the hospital and ultimate diagnosis … Read More »
Sixth Circuit Approves NLRB Micro-Bargaining Units
As originally posted on
On August 15, 2013, the Sixth Circuit Court of Appeals affirmed the National Labor Relations Board’s (NLRB or the Board) controversial ruling in Specialty Healthcare, 357 NLRB No. 83 (2011), which has allowed the proliferation of what some term “micro-bargaining units.” This decision makes it easier for unions to organize employees from all industries into smaller units than in the past and makes it challenging for employers to successfully challenge smaller bargaining units.
The Board’s Specialty Healthcare decision overruled its decision in Park Manor Care Center, 305 NLRB 135 (1991), which set forth the Board’s previous test for determining the appropriateness of a bargaining unit in non-acute healthcare facilities. Park Manor Care established a “pragmatic and empirical community of interest” approach that considered traditional community-of-interest factors, as well as evidence considered relevant by the Board during rulemaking … Read More »
“Dear Doctor” Letters: FDA Removes Behavior Tracking Recommendations from Proposed Guidance
On July 9, 2013, the United States Food and Drug Administration (FDA) announced a modification of certain recommendations contained in the November 2010 draft guidance (Guidance) relating to the content, format, and dissemination of Dear Health Care Provider (DHCP) letters communicating important safety information by manufacturers or distributors of medications or biologics. Specifically, the FDA revised a provision recommending that manufacturers evaluate the extent to which their target audience receive the letters and are aware of the communicated information and removed a provision requiring manufacturers to assess the overall impact of the letters on behavior modification.
Regulating the Content of Dear Health Care Provider Letters
The November 2010 Guidance details recommendations relating to the content and format of DHCP letters. See 75 FR 69449 (Nov. 12, 2010). DHCP letters are used to inform health care professionals about important new safety concerns that … Read More »
Navigating the Isolated DNA Patent Eligibility Jungle
Introduction
For over 150 years the Supreme Court has provided three categories of exceptions to patent eligibility under 35 U.S.C §101: abstract ideas, laws of nature, and physical phenomena, since these are the basic tools of scientific and technological work.[1] The Roberts Court has revised the standard for review of “abstract ideas” and “laws of nature” in Bilski v. Kappos and Mayo v. Prometheus, respectively. The Court’s much awaited decision in AMP v. Myriad addressed the “physical phenomena” exception with respect to patents claiming isolated DNA.[2]
The recent decision in Myriad will have an impact reaching far beyond the patentability of isolated DNA. Patent eligibility for isolated DNA is crucial for the continued growth of the biotechnology and diagnostics industries. The decision, disallowing patenting of isolated DNA, will have a chilling effect on these industries. Furthermore, the decision casts a cloud on … Read More »
Drug Import Regulation: On the Brink of Historic Change
On Friday, July 12, 2013, the Food and Drug Administration (FDA) hosted a public meeting to discuss the implementation of the drug supply chain provisions to Title VII of the Food and Drug Administration Safety and Innovation Act (FDASIA). The meeting included a host of speakers that shared their perspective on the best course of action for implementation of Section 713 (Standards for Admission of Imported Drugs) and Section 714 (Registration of Commercial Importers of Drugs and Good Importer Practices) of the regulations. The meeting was also open to public comment from industry, trade, and other stakeholders who shared their perspective. Since then, industry groups, drug importers, and other stakeholders have been preparing comments to guide the implementation process. Final comments on the implementation of Sections 713 and 714 are due by August 12, 2013.
The globalization of the drug supply … Read More »
This Conversation May Be Recorded
As the pharmaceutical industry changes, it must take note of the impact such change has on employee relations and the potential for lawsuits. Big Pharma has shed thousands of jobs in the past few years, with reports showing that the industry has lost more than 6,000 jobs from January –May 2013, up from the approximately 5000 lost in the first 5 months of 2012. And there will be more to come as the industry continues to react to lab failures, pressure to cut costs and lower prices due to lower profits, and increased competition from generics.
The result is employee disruption felt not only by those displaced, but also by the remaining workforce which often finds itself under stress from having to maintain productivity with fewer numbers, and who may feel threatened by the culture of layoffs. Either way, employee relations … Read More »
CMS Issues Sunshine Act FAQs
CMS recently issued an FAQ clarifying one of the most puzzling questions regarding implementation of the Sunshine Act reporting requirements: whether manufacturers must report transfers of value (“TOVs”) to non-physician employees of teaching hospitals. CMS’s answer is that “[n]on-physician employees of a teaching hospital and non-physician employees of a physician-owned practice or other physician-owned entity are not covered recipients for the purposes of [the Sunshine Act regulations]. Accordingly, payments or other transfers of value made to these non-physician employees generally do not need to be reported.” However, CMS added, the TOV would be reportable if the employer requested that the manufacturer make the TOV to the employee, or if the manufacturer designated that the TOV was made on behalf of the employer. In addition, CMS added that if the manufacturer makes a TOV to a non-physician employee, requiring, instructing or directing that it be passed on … Read More »
Organ Transplantation in Children: What is Ethical?
New ethical questions have been spurred by the recent lung transplantation case involving a 10-year old girl from Pennsylvania. Sarah Murnaghan, who was diagnosed with cystic fibrosis, had been fighting for her life, ever since her grim prognosis. While she was able to work her way up to the top of the donor list for children, 18 months later, the lungs she needed were still nowhere to be found. With her condition worsening over the beginning of this year, she was in desperate need of a transplant, and her parents were running out of options to find a solution.
That is when Sarah’s parents began to question the Organ Procurement and Transplant Network’s Policy 3.7.6, indicating that any child under the age of 12 cannot receive priority for deceased adult donor lungs. Backing up a step, to take a look at the … Read More »
French Sunshine Act Implemented…Awaiting Guidance
As pharmaceutical and device manufacturers and others are scrambling to finalize interpretations and implementation of the U.S. Physician Payment Sunshine Act, the French government added to the activity by releasing similar transparency regulations. On May 22, 2013, the French Ministry of Health published Decree No. 2013-414, implementing the French Sunshine law, which was enacted on December 29, 2011 and is known as the Bertrand law, after the French Minister of Health, Xavier Bertrand. The compliance date was set for June 1, 2013, and reporting is retroactive to January 1, 2012, giving companies a mere 10 days to interpret the regulations and compile and report data. It is expected that a Circular (i.e., guidance document) interpreting the Decree will be released soon.
The French Sunshine law requires reporting by companies that produce, market, or provide services associated with products listed in a particular … Read More »
Overlapping Post-Marketing Challenges for Biopharmaceuticals: Pharamacovigilance, Products Liability, and Biosmiliars
Krista Cosner recently published, “Overlapping Post-Marketing Challenges for Biopharmaceuticals: Pharmacovigilance, Products Liability, and Biosimilars,” in the following publications: Bloomberg Services (May 16), BioTech Watch (May 16), Life Sciences Law & Industry Report (May 17) and the Product Safety & Liability Reporter (June 5).
Read entire article below.
Download (PDF, Unknown)
Privately Held Medical Device and Drug Companies Face Unique Sunshine Act Challenges
As widely reported, the Centers for Medicare and Medicaid Services (“CMS”) recently issued regulations implementing the Sunshine Act provisions of the Affordable Care Act. These regulations require medical device and pharmaceutical companies to submit annual reports to CMS describing all payments and “transfers of value” to physicians and teaching hospitals. Companies must begin to collect data on August 1, 2013, and the first annual report will be due on March 31, 2014. CMS will post the reports on a public website.
Less discussed is the additional reporting duty imposed on privately held drug and device companies. Privately held companies must also report information about each shareholder/owner who is either a physician or who has a physician as an immediate family member. The new regulation defines “immediate family member” broadly to include spouse, parent, child, sibling, stepparent, stepchild, stepsibiling, grandparent, grandchild, and … Read More »
What Goes Up…Must Come Down: Viagra patent invalidated by Canadian Supreme Court
Pfizer and Teva have been fighting a legal battle over Pfizer’s patent for Viagra in Canada. The first shot was fired when Novopharm Limited, now Teva Pharmaceutical Industries, applied for a notice of compliance in order to produce a generic version of Viagra in Canada. Teva alleged that Pfizer’s Canadian Patent 2,163,446 was invalid for obviousness, lack of utility and insufficient disclosure. The lower Federal Court held that the patent was valid because the invention was not obvious. The lower court also concluded that the invention was useful, and that the patent did not fail to adequately disclose it. The lower court prohibited the issuance of the notice of compliance.
Teva dropped its allegations of obviousness, and appealed to the Supreme Court of Canada. In a decision published on November 8, 2012, the Supreme Court held 7-0 that the patent was … Read More »
The Perils and Promise of 3D Printing: Are DIY Life Sciences in Your Future?
With news that 3D printing (without question one of the coolest technologies to come down the road in quite some time) can be used to produce guns, we must now ask ourselves what other things might be built using a 3D printer. What about, say, a medical device? Or human tissue? Or body parts?
Some folks are batting around billion dollar numbers, imagining that the official market for these breakthroughs will be the big story in the years to come. And, to be sure, that “official” marketplace will be an important element in the new world of bio-mechanical printing. But as an IP lawyer, my first thought was this is going to be crazy.
So what is 3D printing, and why is it such a big deal? 3D printing is, as you might imagine from the name, a technology that permits three-dimensional … Read More »
Robyn Shapiro talks about conflicts of interest at MAGI East 2013
Robyn Shapiro spoke in Boston on May 7th at the MAGI East conference. Robyn’s presentation focused on how to deal with conflicts of interest in an evolving landscape. Her review of the Sunshine Rule and its implications in clinical trials and research opened up a lively discussion of how sponsors and researchers can approach this challenging development in regulation
Can Human Genes Be Patented?
On Monday, April 15, 2013, the United States Supreme Court will hear a challenge to Myriad’s patents on two isolated genes, BRCA 1 and BRCA 2. The two patented genes, when mutated, can put women at higher risk for breast and ovarian cancer. With the granted patents, Myriad has secured its position as the only place to go for testing of these genes, with a high price tag. Scientists, researchers and patients who believe the patents are blocking further research and limiting the availability of testing, are leading the challenge against Myriad’s patents.
Below is an in-depth look at patent eligibility and the challenge against Myriad, from Mercedes Meyer (may take a few moments to load):
Download (PPT, Unknown)
Five Tips for Dealing with “First Inventor to File”
It’s here.
Thanks to the America Invents Act (AIA), as of March 16, 2013, the U.S. patent system became a “first inventor to file” system. That is, the inventor who files first will get a patent, even if the inventor who first conceived the idea files at a later date. This is very different from the old system, which was a “first to invent” system that awarded patents to the first inventor, even if that inventor was not the first to file.
The new system obviously puts a premium on timely action. The days of lengthy product testing to flesh out and perfect an invention may be gone forever. The system no longer accommodates those who linger. It rewards those who can move quickly.
Here are some suggestions for being ready to move quickly and exploit “FITF.”
File early. By all means, don’t rush … Read More »
Ninth Circuit Affirms Conviction and Sentence in InterMune Pharmaceutical Marketing Fraud Case
On March 4, 2013, the Ninth Circuit affirmed the conviction and sentence of InterMune founder Scott Harkonen based upon a fraudulent press release that misrepresented the results of a clinical trial in the off-label use of the drug Actimmune to treat the fatal lung disease idiopathic pulmonary fibrosis (IPF). A jury convicted Mr. Harkonen of wire fraud based upon the press release, and the district court sentenced him to three years’ probation and a $20,000 fine. (He also was excluded from participating in federal health care programs for five years, and has challenged that determination with a lawsuit of his own).
Giving great deference to the jury verdict, the Court of Appeals (in an unpublished opinion) rejected Harkonen’s First Amendment challenge to his conviction, finding that there were sufficient facts to support the jury’s findings that the press release misrepresented the … Read More »
Proposed New Requirements on FDA Acceptance of Data from Clinical Studies for Medical Devices
On February 25, 2013, the FDA proposed new regulations to amend its current requirements on the acceptance of clinical data for medical devices. Specifically, the FDA is proposing to amend its acceptance criteria for data from clinical studies outside of the United States used as support for an investigational device exemption (IDE) application, a premarket notification (510k) submission, a premarket approval (PMA) application, a product development protocol (PDP), or a humanitarian device exemption (HDE) application, by requiring that such studies be conducted in accordance with good clinical practice (GCP) standards. In addition, the proposed rule seeks to amend the 510(k), HDE, and IDE requirements for FDA acceptance of data from clinical studies conducted inside the United States to parallel existing FDA requirements for PMA applications. Should these proposed requirements ultimately become final, medical device manufacturers will need to ensure that their clinical … Read More »
Agree to Disagree: FDA and Customs Origin and Drug Labeling Requirements
When merchandise is imported into the United States, there is a slew of information required to be reported to United States Customs and Border Protection (Customs) and the Food and Drug Administration (FDA). The information is transmitted electronically, usually by the importer’s designated customs broker. Among the key elements transmitted to Customs and the FDA is the country of origin of the imported product. Unfortunately, the answer to this question is not always easy, and in many cases Customs and the FDA do not agree. While it may not always be possible to reconcile the two agencies’ requirements, compliance with both is nonetheless required.
Country of origin determination and labeling for pharmaceutical products is a prime example of where the FDA and Customs do not see eye-to-eye. The FDA generally defines origin based on the last country of manufacture. Moreover, FDA … Read More »
Sequestration: The Ripple Effect on the Life Sciences Industry
With sequestration scheduled to take effect today, the looming cuts to the U.S. Food and Drug Administration are concerning for the whole of the life sciences industry. The budget sequestration will cut 8.2% from the federal budget, resulting in about $320 million less in spending for the FDA in FY 13 than it had in FY 12. This will put pressure on the FDA to furlough or lay-off employees. The concern is that these effects will result in slower drug and device approvals, and substantially hamper product development.
The Prescription Drug User Fee Act (PDUFA) law, passed by Congress in 1992, allows the FDA to collect fees from drug manufacturers to fund the new drug approval process. This added funding source allowed the FDA to increase the number of new drug reviewers by 77% in the first eight years of the … Read More »
Yahoo’s Ban on Working from Home: Does it Raise Red Flags for Life Sciences Companies?
Yahoo’s widely reported decision to require its remote workforce to physically report to one of Yahoo’s office locations – or face termination of employment – has caused a social media stir. Here are some of the common questions, and our thoughts about whether Yahoo’s decision signals a trend applicable to Life Sciences companies.
Q: Can Yahoo fire its remote workforce if they refuse to return to the office?
A: For the most part – yes. If employees are employed “at-will,” then they can be fired with or without cause, and without notice. In other words, Yahoo’s statement that they feel the business is best served by the regular, spontaneous interactions resulting from having employees in the office is a legitimate non-discriminatory reason to require employees to return to the offices. Therefore, any employee who refuses to physically report to a Yahoo office location can … Read More »
CMS’s Final “Sunshine” Rule: Implications for Research
On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) released its long-awaited final rule (Final Rule) implementing Section 6002 of the Patient Protection and Affordable Care Act (ACA), commonly known as the “Physician Payment Sunshine Act” (Sunshine Act or Act).[1] The Sunshine Act was included in ACA to enhance disclosure and transparency of financial arrangements among physicians, teaching hospitals, and manufacturers of certain products (federally reimbursable drugs and biologicals as well as covered medical devices and medical supplies), and thereby reduce the risk of inappropriate financial incentives interfering with medical judgment and patient care. The Final Rule details requirements for processing and reporting payments by pharmaceutical, device, biological, and medical supply “applicable manufacturers”[2] to physicians and teaching hospitals that are “covered recipients.”[3] The Final Rule also sets forth requirements for reports of ownership and investment interests held … Read More »
2013 Should Bring Clarity to Analysis of Settlements of Pharmaceutical Patent Litigation
The Federal Trade Commission (FTC) recently filed a brief with the U.S. Supreme Court in a case that promises to bring some clarity to the analysis of settlements of pharmaceutical patent litigation. Under the Hatch-Waxman Act, a generic drug manufacturer can file an application with the Food and Drug Administration (FDA) stating that a pioneer manufacturer’s patent is invalid or that its generic drug does not infringe the patent. By statute, such an application is a technical act of patent infringement, permitting the pioneer manufacturer to file patent litigation. Some of these patent infringement suits are resolved by settlements that include a payment by the pioneer manufacturer to the generic manufacturer, which agrees to refrain from producing its generic drug for a specified period. The FTC refers to these settlement agreements as “reverse payment agreements” or “pay-to-delay” agreements.[1]
The legality of … Read More »
2013 Life Sciences Employment Outlook: What Does It Mean for HR Compliance?
On January 30, 2013, BioSpace.com, an online life sciences recruitment company, released BioSpace Annual Report: Life Sciences Employment Outlook. The report is based on a site demographic study, review of industry job openings from 2010-2012 and salary data collected by BioSpace. The report is cautiously optimistic about employment security/opportunity in the life sciences industry. BioSpace reports that unemployment is down 3.4% since 2010, and average salaries are inching back up from the low point in 2010 towards the high level mark recorded in 2008. Employees with a doctorate or MD degree have the highest spike in average salary growth since 2010.
California, NJ/NY and Massachusetts remain as the top 3 hiring locations in 2012. The study notes that large companies are continuing to explore outsourcing jobs in process, manufacturing and production to overseas locations in India, China and South Korea. As … Read More »
HIPAA/HITECH Omnibus Final Rule: Implications for Research
The Department of Health and Human Services’ HIPAA/HITECH Omnibus Final Rule (Final Rule) includes a number of provisions that will alleviate certain restrictions and administrative burdens in human subjects research and help streamline the documentation associated with research. Here are the significant changes:
Compound Authorizations
The current HIPAA Privacy Rule generally prohibits “compound authorizations,” which are authorizations for use and disclosure of protected health information (PHI) that are combined with any other legal permission. An exception to this general prohibition permits combining an authorization for use and disclosure of protected health information in a research study with any other written permission for the same study, including an informed consent to participate in the research. However, until March 26, 2013, the effective date of the Final Rule, even the same study exception is unavailable if one of the authorizations or permissions conditions treatment, … Read More »
Affliction and Social Media
Tasteless comments about the growth of social communication often fall back on the hackneyed metaphor of “spreading like a cancer.” The growth is uncontrolled, we are told, metastasizing in unexpected locations with ruthless speed. The body politic, we are told, is being rotted within by mutation. The traditions of the past are under siege, and we require radical surgery for a cure.
The panic is unwarranted, but the metaphor may be more apropos than we realize.
The astonishing (and Pulitzer Prize–winning) The Emperor of All Maladies describes the halting progress made in the fight against cancer since it was first identified by the Egyptian physician Imhotep 4500 years ago. For most of that grim history, cancer has been misunderstood, misidentified, and a hopeless diagnosis for its victims. Research was driven by a small number of obsessed, charismatic individuals, many of whom were … Read More »
UPDATE: Second Circuit Rejects Government’s Off-Label Enforcement Approach
UPDATE TO EARLIER POST:
On Wednesday, January 23, Food and Drug Administration officials said the government will not appeal the decision in the United States v. Caronia, No. 09-5006-cr (2d Cir. Dec. 3, 2012). The FDA decided against asking the court to rehear the case, and will not appeal to the Supreme Court. The FDA stated that it “does not believe that the Caronia decision will significantly affect the agency’s enforcement of the drug misbranding provisions of the Food, Drug & Cosmetic Act.”
Read Jesse Witten’s recent post on this case here.
HHS Releases HIPAA Omnibus Final Rule
On January 17, 2013, the Department of Health and Human Services (HHS) publicly released the long-awaited HIPAA Omnibus Final Rule (Final Rule). The Final Rule (1) implements many provisions of the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act), expanding the privacy and security standards directly governing covered entities and business associates; (2) modifies the interim final rule for Breach Notification for Unsecured Protected Health Information (Breach Notification Rule); (3) modifies the HIPAA Privacy Rule to strengthen the privacy protections for genetic information by implementing section 105 of Title I of the Genetic Information Nondiscrimination Act of 2008 (GINA); and (4) makes certain other modifications to the HIPAA Privacy, Security and Enforcement Rules to improve their workability. Notably, the Final Rule does not address the anticipated accounting of disclosures requirements, which was the subject of … Read More »
Long-Awaited HIPAA and HITECH Final Rule Released
A final omnibus rule has been released by the Department of Health and Human Services. The final rule makes changes to the Health Insurance Portability and Accountability Act (HIPAA) regulations related to privacy and security. The final rule, in its entirety, can be found here.
Check back soon for a response from our life sciences team.
Follow continued coverage from our Government & Regulatory Affairs colleagues here.
Where to Spend Your Healthcare Investment Dollars
In a blog entry written over the summer, I expressed the view that the next 5-10 years will present tremendous transactional opportunities in the life sciences/health care industry. Nothing has happened to dampen that view. In fact, President Obama’s reelection, which means that the Patient Protection and Affordable Care Act is here to stay and will be fully implemented over the next few years, and our ongoing deficit reduction concerns, mandate that efficiency, cost control and strategic ways to provide better quality healthcare will be at center stage. So let’s focus in on some investment opportunities that may be interesting.
For those willing to tackle regulatory and reimbursement hurdles, there should be many opportunities in the provider world. This could take the form of hospital mergers and consolidations, spin-off of various medical and lab services that have been provided at hospitals and … Read More »
Second Circuit Rejects Government’s Off-Label Enforcement Approach
Last week’s decision in the off-label promotion case, United States v. Caronia, No. 09-5006-cr (2d Cir. Dec. 3, 2012), is an important blow to the Government’s off-label promotion efforts. In a 2–1 decision, the Court squarely rejected the simplistic theory that the Food, Drug and Cosmetic Act (“FDCA”) imposes a blanket prohibition against off-label promotion by pharmaceutical and device manufacturers, but it does leave open the door to future prosecutions that rely in part on off-label promotion.
In Caronia, the Department of Justice obtained the conviction of Alfred Caronia, a pharmaceutical sales representative, for conspiracy to introduce a misbranded drug into interstate commerce. The FDA prohibits the introduction into interstate commerce of a misbranded drug (or device). 31 U.S.C. § 331(a). A drug is misbranded if, among other ways, its labeling fails to contain “adequate directions for use,” 21 U.S.C. § 352(f), … Read More »
Massachusetts Refines Its Sunshine Law; Final Federal Sunshine Regulations Moving Ahead
The relationship between health care providers and drug and device manufacturers has been a focus of lawmakers at both the federal and state level. While we continue to await final federal regulations implementing the Physician Payment Sunshine Act (federal Sunshine Act), which generally requires disclosure of financial arrangements among physicians, teaching hospitals, and drug and device manufacturers,[1] Massachusetts has refined its requirements governing relationships between physicians and drug and device manufacturers. Amendments to the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct regulations[2] (the Massachusetts Regulations) broaden the scope of permissible meals and refreshments that may be provided by manufacturers to health care practitioners and clarify issues related to preemption of the Massachusetts Regulations by the federal Sunshine Act. The Massachusetts changes and impending release of final federal regulations underscore the continuing need for drug and device manufacturers to … Read More »
Whistleblower Lawsuit Against Drug Maker Fails Because “Off-Guideline” Marketing Does Not Constitute “Off-Label” Marketing
In welcome news for the pharmaceutical industry, the U.S. District Court for the Eastern District of New York, in United States ex rel. Polansky v. Pfizer, Inc., 2012 U.S. Dist. LEXIS 163557 (E.D.N.Y. Nov. 15, 2012), issued a decision distinguishing between unlawful “off-label” marketing and lawfully marketing a drug for use outside of recommended guidelines. By way of background, the Food and Drug Administration approves “labels” (which, in some cases, may be lengthy and more akin to pamphlets or brochures) that must accompany prescription medications. A label states the purposes for which a medication has been determined to be safe and effective, and pharmaceutical companies are prohibited from promoting or marketing the medication for other “off-label” uses.
Since early 2004, Pfizer, Inc. has been defending a qui tam action that its former Director of Outcomes Management Strategies, Dr. Jesse Polansky, filed under … Read More »
DOJ and SEC Issue Long-Awaited Resource Guide to the Foreign Corrupt Practices Act
On November 14, 2012, the Department of Justice and the Securities and Exchange Commission published their much anticipated Resource Guide to the U.S. Foreign Corrupt Practices Act.1 There is little new in the Guide to clarify the circumstances under which the government will charge companies or individuals with FCPA violations. Instead, the Guide reiterates previous government pronouncements that the FCPA should be construed broadly, and cites its own charging decisions as “authority” for what the statute proscribes. Basically, the Guide is a comprehensive compilation of “authority” formerly found only in various Government press releases, settlement agreements and guilty pleas. Thus, the guidance is somewhat of a disappointment for the experienced FCPA practitioner and for companies that already have robust compliance programs. In a few areas – notably in its discussion of gifts, travel and entertainment – the Guide does offer … Read More »
Patent War Between St. Jude Medical and Volcano Has Mixed Results
St. Jude Medical and Volcano have been embroiled in a legal battle over patents held by both companies, related to pressure wire technology that is used for heart patients. The battle began over two years ago when St. Jude Medical sued Volcano, in Delaware district court, for infringement of 5 of its patents for pressure guide wire products. The patents in suit were U. S. Patent No. 5,938,624, U.S. Patent No. 6,196,980, U.S. Patent No. 6,112,598, U.S. Patent No. 6,167,763 and U.S. Patent No. 6,248,083. St. Jude requested an injunction and damages for infringement of the five asserted patents.
Volcano replied by counterclaiming, alleging that St. Jude Medical had infringed four of its own patents, but later dropped one of those patents from the suit. The three remaining patents asserted by Volcano against St. Jude were U.S. Patent No. 6,976,965, U.S. … Read More »
Tougher Sanctions on Iran: What it Will Mean for Businesses
Tougher sanctions went into effect on October 9, 2012, that broadly expand the extraterritorial reach of the U.S. Government with regard to conducting business with Iran. Most significantly, with the Iran Threat Reduction and Syria Human Rights Act of 2012, any business owned or controlled by a U.S. parent may expose its parent to sanctions for its business activities with Iran.
Significantly, the new law allows for the imposition of civil penalties of up to $250,000, or twice the value of the transaction, for activities completed by any foreign entity owned or controlled by a U.S. parent, if such activities would violate U.S. sanctions laws if they were to be undertaken in the U.S. or completed by a US person. Stated another way, if a U.S.–owned or U.S.–controlled foreign entity enters into a transaction with an Iranian party that the parent … Read More »
New post from Capitol Health Record on call for more new medicines from Presdient’s Council of Advisors on Science & Technology
Published by Capitol Health Record on October 3, 2012
Written by: Amy Walker
Last week, the President’s Council of Advisors on Science and Technology (PCAST) released their “Report to the President on Propelling Innovation in Drug Discovery, Development, and Evaluation.” The report recommends that the United States set a goal of doubling the number of new medicines “that meet critical public health needs” over the next ten to 15 years.
PCAST, which was formed in April 2009 by President Barack Obama, is an advisory group consisting of leading scientists and engineers which makes science and technology policy recommendations to the President and the Executive Office of the President.
For the report, PCAST analyzed trends and challenges in biomedical research and development over recent years, finding that scientists need better methodologies and tools for translating discoveries and pharmaceutical developers and regulators need to incorporate efficiencies … Read More »
The Federal Circuit’s Recent “Safe Harbor” Ruling Could Impact Biosimilars Drug Development
A recent Federal Circuit case, Momenta v. Amphastar, involves the Hatch-Waxman 271(e)(1) safe harbor, and is rousing the biologics and biosimilars industry. In particular, the court held in Momenta, that section 271(e)(1) does apply to certain post-approval activities.
As background, Momenta Pharmaceuticals, Inc. and Sandoz Inc. filed for a preliminary injunction against Amphastar Pharmaceuticals, Inc., International Medication Systems, Ltd., Watson Pharmaceuticals, Inc. and Watson Pharma, Inc. in the U.S. District Court for the District of Massachusetts alleging infringement of U.S. Patent No. 7,575,886. The ‘886 patent generally claims processes for analyzing heterogeneous populations of sulfated polysaccharides. Momenta alleged that Amphastar infringed the claimed processes when developing and manufacturing of batches of generic Lovenox (enoxaparin), a low-molecular-weight complex polysaccharide, for commercial sale. (Momenta used the claimed processes to gain approval of its own generic enoxaparin one year earlier.) The district court granted Momenta a preliminary injunction, concluding that Amphastar’s testing … Read More »
Are Biosimilars the Next Generation of Small Drug Manufacturers?
New reports suggest that while generic drug makers are aggressively consolidating in the United States and United Kingdom, smaller generic drug manufacturers’ viability is threatened, forcing them to seek niche therapeutic areas. Manufacturing biosimilar biologicals may be an answer for the smaller generic drug companies, due to several factors. First, while manufacturing complexities create market entry barriers, recent shortages of the biologics supply in the U.S. have increased the market demand. Also, low margins are causing large manufacturing companies to exit the biologics market. Furthermore, the patents for many top selling biologics will expire in the next 3 to 5 years, creating an opportunity for new market entrants. Finally, the new abbreviated approval pathway for biosimilars in the U.S. may be more conducive to the needs of smaller firms: efficient approval process, lower development costs, and protection for first generation biologics.
Background
In … Read More »
Electronic Health Records: Looking Past Skepticism
With more instances of Electronic Health Record (EHR) data breaches popping up in the news, skepticism is beginning to build as to whether or not the health care industry can handle the switch from paper to digital. In the most recent incident, The Surgeons of Lake County, located in northern Chicago, fell victim to a data breach by hackers who were able to gain access to e-mails and electronic medical records. Adding to the nation’s interest in this specific incident, the hackers have encrypted the data, holding it “hostage” for ransom from the health care facility. The hackers are demanding payment in exchange for a password that will allow doctors to regain access to their patients’ electronic health records.
Aside from data breaches, EHRs have come under fire for other kinks and flaws related to their implementation. In late July, a … Read More »
The FDA Proposes New Rule on Unique Medical Device Identification and Marking Requirements
The United States Food and Drug Administration (FDA) has proposed a rule establishing a unique device identification system for medical devices and requiring a unique device identifier (UDI) to be placed on medical devices and device packages. See 77 FR 40736 (July 10, 2012). The FDA intends the unique device identification system to reduce medical errors, create greater accuracy in adverse event reporting and post-marketing surveillance, and facilitate recalls. The proposed rule, which was promulgated in accordance with the Food and Drug Amendments Act of 2007, is the result of pilot testing and public input. The UDI requirements, process, and implementation schedule are of particular interest to medical device and instrument manufacturers, and will have an impact on manufacturing and supply chain operations. Comments on the proposed rule may be submitted to the FDA by November 7, 2012.
Goals of the … Read More »
Pharmaceutical Industry Executives Face Enforcement Risks Under The Responsible Corporate Officer Doctrine
The recent decision of the D.C. Circuit in Friedman v. Sebelius, No. 11-5028 (D.C. Cir. July 27, 2012), demonstrates the enforcement risk to pharmaceutical and medical device industry executives under the “responsible corporate officer” (RCO) doctrine. Under the RCO doctrine, officers, managers and in-house counsel employed by life sciences companies could face misdemeanor criminal liability and exclusion from Medicare and other federal health programs, even if they were not personally involved in wrongdoing. Indeed, an executive can be liable under the RCO doctrine even if they did not know that their organization had engaged in wrongdoing, so long as the executive should have known of the organization misconduct by virtue of the executive’s position within the organization.
The RCO doctrine originated in United States v. Dotterweich, 320 U.S. 277 (1943), in which the Supreme Court upheld the misdemeanor conviction of the president of a … Read More »
House Bill Introduced on Clinical Trial Database Registry
On August 2nd, H.R. 6272, the “Trial and Experimental Studies Transparency (TEST) Act of 2012” was introduced in the House. TEST would amend the Public Health Service Act to expand the clinical trial registry data bank. Among other requirements, the bill would require all foreign clinical studies to meet the same requirements as domestic trials (if used to support an application for U.S. marketing).
Also, the bill would require that results from most covered trials be posted on the registry data bank within one year of the “primary completion date” of the trial. Delayed submission of results up to two years after trial completion would be allowed for trials on drugs of devices that have no previous history of approval for use. The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) would be instructed to provide Congress … Read More »
Social Medicine?
It isn’t difficult to see that the main impact of social media penetration in our culture is an epidemic of oversharing. Americans under the age of 25 have a very different approach to privacy than, say, your average 30 year-old, and feel weirdly comfortable sharing details of their private lives. E-mail is considered to be outlandishly formal, large scale sharing over social networks and texting is commonplace, and the barriers between personal and institutional communication are nearly non-existent.
This has led, predictably, to mass sharing of medical information online — even two years ago, news organizations were reporting on the rise of “e-patients” who talk to medical experts and amongst themselves in order to obtain treatment, piece of mind and/or the thrill of exposure.
Suddenly, there is widespread information about adverse outcomes and side effects, in every search that someone does for … Read More »
Jesse Witten featured on Inside Counsel
On August 3, 2012, Jesse Witten published an article on his thoughts on Eucomed’s code of ethics.
To read the entire article, click here.
Tremendous Transactional Opportunities
For deal junkies, the next 5-10 years should be quite interesting in the life sciences/health care industry. We have already seen large pharmaceutical company consolidations, financial buyers investing in health care institutions and partnerships between payors and providers. And much of this before the Supreme Court decided that health care reform is here to stay.
What is driving this? Need, opportunity, cash and innovation. Pharmaceutical company brand drugs are losing their patent protection, the cost/risk of developing new drugs is enormous, heath care costs need to be controlled, people are living longer, health care reform is triggering new behaviors and strategies and, despite the difficult financial times, there is much cash available for investment. Also, much of the broader life sciences/health care industry has been slow in technology adoption, while technology and social media continues advancing, being available to a broader … Read More »
Medical Device Security: How Safe is Wireless Technology?
The health care industry has seen a jump in the number of medical devices that use wireless technology. With this rapid technologic development comes concern about the safety, security and privacy of patients. There is specific concern in this regard with respect to the following commonly used devices: Implantable Medical Devices (IMDs), External Medical Devices, and Portable Devices.[i]
Last year a security researcher successfully demonstrated how an outside breach of a wireless insulin pump allows for the hacker to shut off or alter the settings of the device. This poses a serious risk for those with portable and implantable medical devices that are controlled via wireless technology. In addition to a breach of control of these devices, the risk of malware on such FDA-approved medical devices is also a concern. In the event that an FDA-approved medical device is infected with … Read More »
First-Ever Electronic Medical Records and Advanced Imaging Technology Being Brought to 2012 London Olympics
For the first time in Olympic history, advanced imaging technology will be used to help detect athletes’ use of performance-enhancing drugs. GE Healthcare Life Sciences’ biomolecular imager will lend a big hand in helping to test athletes for recombinant erythropoietin (EPO), a performance-enhancing drug used to boost the number of red blood cells, which enables improved oxygen flow and allows athletes to raise their workout intensity and endurance. The GE provided equipment, the ImageQuant LAS4000, uses technology that offers extremely detailed information to accurately identify EPO doping. We first saw the popularity of this drug grow among Tour de France cyclists.
Many other tests will be performed, in addition to the EPO test, in an attempt to create the most advanced drug testing laboratory in the history of the Olympics. GlaxoSmithKline will be the official lab services provider for the 2012 Olympic and … Read More »
Thoughts on the D.C. Pharmaceutical Detailer’s License Requirement
The District of Columbia regulates many activities that go unregulated in other jurisdictions. One example relevant to pharmaceutical companies is the requirement that in D.C., detailers must obtain a license before they may speak in person with a physician, nurse or other health professional. Pharmaceutical detailers also must undergo 15 hours of continuing education every two years and must keep records of their interactions with licensed health professionals or their employees.
The District of Columbia requires that individuals obtain a license from the D.C. Board of Pharmacy in order to engage in the practice of “pharmaceutical detailing” in D.C. See D.C. Code § 3-1207.41; 17 DCMR § 8300.1. A person is engaged in pharmaceutical detailing if, acting as a representative of a pharmaceutical manufacturer or labeler, he or she communicates in-person with a licensed health professional or a representative of a licensed … Read More »
Still Waiting for Guidance on Informed Consent of Decisionally-Impaired Subjects
A July 11, 2012 article by Gina Kolata in the New York Times describes a recent discovery of a rare gene mutation that protects people from Alzheimer’s disease by slowing the production of beta amyloid. Excessive amounts of beta amyloid in the brain are believed to cause Alzheimer’s. The discovery bolsters hope that drugs, currently in development, that reduce levels of brain amyloid will prove effective in slowing the progression of Alzheimer’s.
The lack of clear guidelines for enrolling in clinical research decisionally-impaired subjects, or those who may become impaired over the course of a study may hinder efforts to conduct trials of Alzheimer’s drugs. In 2010, an Institute of Medicine summary of a workshop on the state of clinical trials in the United States noted that 27% of investigators in the U.S. failed to enroll any subjects in trials in … Read More »
Massachusetts Amends Its Drug and Device Marketing Law
On July 8, Governor Deval Patrick signed a bill amending the Massachusetts law regulating marketing activities by pharmaceutical and device manufacturers, one of the strictest state laws in the country.
The law previously barred pharmaceutical and device manufacturers from providing meals to health care practitioners outside the practitioner’s office or hospital setting. See 111N Mass. Gen. Laws § 2. The amendment will now permit pharmaceutical and device manufacturers to provide modest meals and refreshments outside of the practitioner’s office or hospital setting, if the meal or refreshment is furnished with a non-CME educational presentation for the purpose of providing bona fide medical information, and the meal is furnished in a venue and manner conducive to communicating information. The amendment directs the Massachusetts Department of Public Health to promulgate regulations to define “modest meals and refreshments.” Pharmaceutical and device companies, however, will … Read More »
Q&A with Drinker Biddle’s Jesse Witten
Jesse Witten was recently interviewed by Law360 Life Sciences:
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Q&A With Drinker Biddle’s Robyn Shapiro
Robyn Shapiro was recently interviewed by Law360 Life Sciences:
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U.S. Supreme Court’s Affordable Care Act Decision: Impacts on Life Sciences
The June 28, 2012 U.S. Supreme Court decision upholding the Patient Protection and Affordable Care Act (“Act”) impacts the life sciences industry in a number of ways, including impacts on innovation and compliance initiatives by medical device, pharmaceutical, and biotechnology companies.
Innovation
A number of provisions in the Act provide incentives and resources for product innovation. First, it is expected that more than 30 million Americans will obtain health care coverage on account of the Act. A bigger pool of Americans with health coverage to pay for treatment will yield growth in pharmaceutical sales and, perhaps, the ability to charge higher drug prices, which, in turn, could spur innovation. In addition, the Act created the Therapeutic Discovery Project Program, through which $1 billion in new therapeutic discovery project grants and tax credits will be awarded. In 2010, 2,923 companies specializing in biotechnology … Read More »
Drug and Device Development Outsourcing
As companies outsource drug and device development overseas, reducing development time and research and development costs, additional legal concerns are raised. Last month a Shanghai court sentenced a researcher, employed by a leading Chinese pharmaceutical research firm, with 18 months’ probation, and ordered the employee to pay restitution for stealing and selling two patented compounds, owned by Merck.
The compounds were developed at the research firm, on behalf of Merck. Apparently the employee gained access to the compounds and sold them illegally. This case raises two important issues for manufacturers who outsource. First, can the outsourcing agreements with research firms adequately protect intellectual property rights and data from this type of misappropriation? Secondly, do patent portfolio strategies need to take into consideration these types of risks? To learn more about the case see the article attached….
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HHS-OIG Changes Boilerplate in its Advisory Opinions, But It’s Still Unfair
I just noticed that in late 2011, the HHS-OIG modified some of the boilerplate in its advisory opinions. The boilerplate is very objectionable, probably calls for a due process violation, and may well be disregarded by a court.
Since late 2011, HHS-OIG advisory opinions have contained the following sentence stating that advisory opinions may not be introduced in evidence to show that a person (other than the person requesting the advisory opinion) did not violate the Anti-Kickback Statute or Civil Monetary Penalties Law:
This advisory opinion may not be introduced into evidence by a person or entity other than [name redacted] to prove that the person or entity did not violate the provisions of sections 1128, 1128A, or 1128B of the Act or any other law.
Previously, the comparable boilerplate sentence stated:
This advisory opinion may not be introduced into … Read More »
Drinker Biddle’s Health Government Relations Team Hosting: Health Care Reform & Supreme Court Review Webinar
From Capitol Health Record: By the end of June, it is expected the Supreme Court will rule on the constitutionality of the Patient Protection and Affordable Care Act. Join us to gain a better understanding of the four questions before the Court and the political, legislative and regulatory implications of the Court’s pending decisions. Our panel also will discuss the different possible outcomes of the Court’s deliberations and their respective political and policy ramifications. Regardless of where you work or who you represent, this presentation will provide important insight and analysis to help inform your business, association, legislative and/or regulatory planning.
Register now to participate in this webinar, featuring the DBR Health Government Relations team!
U.S. clinical trial website pairing — a need for privacy safeguards
Fox Trial Finder is a welcomed initiative in ongoing efforts to facilitate clinical trial participation. In a recent interview with ABC’s Diane Sawyer, Michael J. Fox, who suffers from Parkinson’s disease, said that in addition to his support for stem cell research addressing Parkinson’s, he also supports research looking for a cure on other fronts, including drug therapies and diagnostic tests. (Article Link) Toward that end, Fox’s Foundation for Parkinson’s Research recently launched an online initiative called Fox Trial Finder. This website promotes research across the country by pairing patients with clinical trials in their areas, based on the individual’s symptom profile. The foundation’s webpage notes that 30% of all clinical trials fail to recruit even one subject, and that 85% of clinical trials are delayed because of insufficient subject enrollment – so Fox’s initiative (and others like it that … Read More »
World’s First Stem-Cell Drug Approval Achieved in Canada
On May 17, 2012, Osiris Therapeutics announced that Canadian health regulators approved Prochymal, its drug for acute graft-versus host disease in children who have failed to respond to steroid treatment. Prochymal is the first stem cell drug to be approved anywhere in the world for a systemic disease. Graft-versus-host disease, a potentially fatal complication from bone marrow transplant, involves the newly implanted cells attacking the patient’s body. Until now, there have been no approved treatments for the disease. Prochymal is designed to control inflammation and promote tissue regeneration. Since the drug is made up of bone marrow stem cells derived from an adult donor, it circumvents ethical concerns that are raised by the use of stem cells derived from embryos. The Canadian approval is contingent on Osiris conducting further post-market testing—and it’s anticipated that if the FDA approves the drug when … Read More »
7th Circuit Finds Pharma Sales Reps are Exempt Employees on Eve of Anticipated Ruling from Supreme Court
In a significant opinion for the pharmaceutical industry, the U.S. Court of Appeals for the Seventh Circuit found this week that pharmaceutical sales representatives at Eli Lilly and Abbott Laboratories are exempt from overtime under the administrative employee exemption in the Fair Labor Standards Act (“FLSA”). That exemption applies to employees who 1) primarily perform nonmanual work directly related to the business of the employer, and 2) exercise discretion and independent judgment with respect to matters of significance to the business of the employer.
The Seventh Circuit, rejecting the position of the Department of Labor as amicus curiae, found that the administrative exemption applied because the substantial work of the sales representatives is to prepare for, make, and document their sales calls to physicians to persuade them to prescribe the companies’ products, and that they exercise “significant discretion in the manner and mode of delivery of … Read More »
Abbott Off-Label Settlement Facts and Figures
The government has made available materials relating to Abbott’s $1.5 billion settlement. (See link below). Here are some quick observations.
Abbott pled guilty to a misdemeanor for “misbranding” its drug Depakote as a result of off-label promotion. Between January 1998 and December 2006, Abbott promoted Depakote to treat behaviors associated with dementia, but FDA had approved the drug only to treat certain types of epileptic seizures and biopolar mania, and to prevent the onset of migraines. (That’s all according to the Plea Agreement and Agreed Statement of Facts filed in court). Abbott has agreed to pay a criminal penalty of $500 million and an additional forfeiture of $198.5 million.
The documents filed in court as part of the plea indicate that the value of the misbranded drugs was $198.5 million (that’s why the forfeiture was for that amount) and that Abbott … Read More »
A Rose By Any Other Name … May Carry A Higher Duty Rate
As countries work to harmonize international trading rules and develop bilateral and regional Free Trade Agreements (FTA), there remain certain international trade truths that all international traders should understand. Central to those is the principle of tariff classification. No matter the country, all imported products must be classified under the Harmonized Tariff System and will be assessed duty at the corresponding duty rate applied by the importing country. This globally managed system of tariff classification is guided by the World Customs Organization (WCO) and applies to all WCO member states.
International trade truth number two is that all merchandise must be classified, and therefore assessed duty, based on its condition at the time of entry. Tariff classification may be based on a variety of factors, including what a product is, its material composition, how it works, where it is used, and to whom it … Read More »
New FDA Informed Consent Requirements for Applicable Clinical Trials: Practical Approaches for Implementation
For applicable clinical trials regulated by the U.S. Food and Drug Administration (FDA) that are initiated on or after March 7, 2012, sponsors, investigators and institutional review boards will have to assure compliance with an additional informed consent requirement.1 A revision of FDA regulations requires investigators and sponsors of such clinical trials to include the following statement in informed consents:
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Website will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
ClinicalTrials.gov is the National Institutes of Health (NIH) website where all “applicable clinical trials” must be registered and trial results posted in accordance with the U.S. Food Drug Administration Amendment Act of 2007 (FDAAA).2 Registration … Read More »
CMS’s Proposed “Sunshine” Regulations: Implications for Research
On Dec. 19, 2011, the Centers for Medicare & Medicaid Services (CMS) released a Proposed Rule to implement § 6002 of the Patient Protection and Affordable Care Act (PPACA), commonly referred to as the Physician Payment Sunshine Act (Sunshine Act). The Sunshine Act was included in PPACA to enhance disclosure and transparency of financial arrangements among physicians, teaching hospitals, and manufacturers of federally reimbursable drugs and biologicals and covered medical devices and medical supplies, and thereby reduce the risk of inappropriate financial incentives interfering with medical judgment and patient care. The Proposed Rule details requirements for processing and reporting payments by pharmaceutical, device, biological and medical supply “applicable manufacturers”1 to physicians and teaching hospitals that are “covered recipients.”2 The Proposed Rule also sets forth requirements for reporting ownership and investment interests held by physicians and their immediate family members in applicable … Read More »
Life Sciences – Just Another Way to Say “Intellectual Property”?
There is no corner of the American economy more deeply dependent on intellectual property rights than the life sciences. Of course, we all know that patents have long been central to the success of pharmaceutical and medical device manufacturers, and the unanimous decision in the Prometheus case this past month has brought additional scrutiny to a market segment often misunderstood in the popular press. That said, for players in the life sciences space, patents are only one of many ways that intellectual property shapes their business. In fact, the trademark, unfair competition and copyright laws can be just as critical, and a strategic understanding of their value can provide companies with real ownable distinction in the market.
What is a product with “ownable distinction?” It is the opposite of a generic commodity, and it is the holy grail in the life sciences. It … Read More »
The FTC Finally Issues its Report on Consumer Privacy
Interactive marketing is everywhere, and the Federal Trade Commission has struggled mightily over the past several years to deal with complex privacy issues that grow out of sophisticated, data-intensive marketing practices. On March 26, the FTC released its long-promised final report on consumer privacy. Critically, we now have a sense of the FTC staff position on future legislation, best practices and the secondary market in customer data.
The FTC was clear that it wants additional legislation to address general privacy concerns, data security and breach notifications. This is a change from the staff’s prior position that self-regulation would be sufficient, and lends weight to current efforts before congress to do exactly that (although the fact that we are currently in a highly partisan election year does diminish the likelihood of immediate action).
The rest of the report flowed logically from the principles … Read More »