Late last week, the U.S. Food and Drug Administration (FDA) announced that it was once again delaying implementation of the final rule issued January 9, 2017 related to amendments to its regulations regarding intended use (Final Rule). This implementation delay follows a Petition to Stay and for Reconsideration (Petition) filed February 8, 2017 by the Medical Information Working Group (MIWG), the Pharmaceutical Research and Manufacturers of America (PhRMA), and the Biotechnology Innovation Organization (BIO). The Petition argued that the Final Rule’s inclusion of a “totality of the evidence” standard is a new standard not found in the Food, Drug, and Cosmetic Act (FDCA) or case law related to intended use and was promulgated in violation in the APA because parties subject to this significant liability standard did not receive fair notice or a meaningful opportunity to comment.
Tag Archives: FDA
Deadline Looms for Pharmaceutical Manufacturers and Distributors to Comply with New Expanded Access Program Reporting Requirements
Certain pharmaceutical manufacturers and distributors of an investigational drug under an investigational new drug (IND) application must make their policies for evaluating and responding to requests under an expanded access program “public and readily available” by the end of this week pursuant to section 3032 of the 21st Century Cures Act (Cures). Cures, which became effective on December 13, 2016, provided a deadline for making the policies available on the later of: (i) 60 days after the enactment of Cures, or (ii) the first initiation of a phase 2 or phase 3 study with respect to the investigational drug. Therefore, the 60-day deadline expires on Saturday, February 11, 2017, for those manufacturers and distributors who are already conducting a phase 2 or 3 study under an IND. Continue reading
A notice was published today in the Federal Register regarding a two day public hearing that will be held on November 9-10, 2016 by the U.S. Food and Drug Administration (FDA) to obtain input from a wide range of stakeholders regarding communications by industry related to unapproved uses of FDA-regulated drugs, biological products and medical devices (collectively, “Medical Products”). The announcement noted that FDA has been engaged in a comprehensive review of its regulations and policies related to off-label communications of approved or cleared Medical Products since 2014, and input from the meeting will further inform FDA’s policy development.
All is Well: FDA to Host Webinar on its Final Guidance for Low-Risk General Wellness Devices on September 1, 2016
The U.S. Food and Drug Administration (FDA) recently released final version of its guidance, General Wellness: Policy for Low-Risk Devices (Policy), with a webinar slated for September 1st as part of the rollout. While not much has changed from the 2015 draft guidance, the number of mobile apps and general wellness products that are pushing the limits of what the FDA believes could be “devices” under the Food, Drug, and Cosmetic Act (FDCA) increases daily.
In order to fit under the FDA Policy, the product needs to both solely marketed for general wellness and present a low risk of safety to the user and other persons. The guidance provides useful examples that anticipate the desire to help “reduce the risk of” or “live well with” chronic conditions, the most interesting boundaries of the Policy for those wishing to differentiate themselves within the wellness industry.
Agency metrics on the 513(g) Requests for Information may provide some feedback on the impact of the Policy since its draft issuance, and future enforcement needs to be monitored for defining the limits of the Policy.
Chairwoman Edith Ramirez of the Federal Trade Commission (FTC) announced the release of new guidance directed towards developers of mobile health apps (the “Guidance”), while speaking today at the International Association of Privacy Professionals (IAPP) conference in Washington, DC. The Guidance is a tool created in collaboration with the FTC, the U.S. Department of Health and Human Services (HHS), and the Food and Drug Administration (FDA) to assist app developers in determining what laws and regulations apply to their products. Continue reading
Recently, the U.S. Food and Drug Administration (FDA) published draft guidance entitled “Postmarket Management of Cybersecurity in Medical Devices” (the Guidance) that sets forth ways in which medical device manufacturers should monitor and address cybersecurity risks. The Guidance is the latest manifestation of a federal agency weighing in on the continually growing concern caused by cybersecurity threats. Suzanne Schwartz of the FDA’s Center for Devices and Radiological Health commented that the Guidance “will build on the FDA’s existing efforts to safeguard patients from cyber threats by recommending medical device manufacturers continue to monitor and address cybersecurity issues while their product is on the market.”