Tag: Pharmaceutical
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 »
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 »
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 »
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 »
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 »
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 »
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 »