FDA Policy/General

Biden Impact on FDA Centers/Programs Analyzed

Three Covington & Burling attorneys say a stronger regulatory focus can be expected at FDA in the administration of president-elect Joe Biden. In an online post, the attorneys outline their expectations by Center and program.

CBER and CDER

additional effort to promote generic and biosimilar competition;
supply chain and “Buy American” policies through greater use of the Defense Production Act and Procurement Act of 1949 and using the Biomedical Advanced Research and Development Authority to make science-based purchasing decisions and strengthen federal stockpiles;
permission for states to import drugs from Canada, possibly leaving the FDA final rule on the importation of drugs from Canada in place;
increased support for regenerative medicine efforts; and

continuing efforts toward decentralized clinical trials using digital health technologies.

CDRH

MDUFA 5 negotiations with the possibility for additional device and diagnostic reforms sought by some Democratic members of Congress;
a return to prior levels of quality system and promotional Warning Letters;
little change to premarket review;
administration may review and revoke the August HHS policy on laboratory-developed tests.

Dietary Supplements

FDA may push to modernize the Dietary Supplement Health and Education Act to expand agency authority over dietary supplements and industry should be prepared to consider what it would like to see in such legislation.

CBD

FDA efforts to find a pathway toward allowing CBD in food and dietary supplements likely to continue at a slow pace, while a guidance on the agency’s CBD enforcement policy that has been at the Office of Management and Budget for review could be changed.

CVM

CVM can be expected to focus on antibiotic resistance associated with dose-form animal antimicrobials.

OTC Drugs

CDER will continue to focus efforts on implementing the over-the-counter monograph reform legislation that was passed as part of the Coronavirus Aid, Relief, and Economic Security Act.

Digital Health, Real-World Evidence, and Technology Initiatives

a fresh look at FDA digital and technology initiatives given that some congressional Democrats have raised questions about the agency’s precertification pilot and the acceptance of real-world evidence.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome