Tag: FDA
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 »
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 »
“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 »
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 »
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 »