By Pete Evich, AAHP Government Relations
As part of the President’s FY 2023 Budget proposal, FDA has called upon Congress to take up legislation that would give the agency additional authorities over accelerated approval of drugs and the ability to impose new requirements for dietary supplement makers and cosmetics facilities, among other statutory changes to the Food, Drug, and Cosmetics Act.
FDA’s proposals were released alongside the agency’s fiscal 2023 budget proposal that asks Congress for $3.7 billion in discretionary funding, an increase of $356 million, or nearly 11%, over fiscal 2022 levels.
FDA wants Congress to allow the agency to require sponsors of accelerated approval drugs — those whose applications have been accepted for filing or that have received approval — to first demonstrate that a proposed post-approval study is adequately designed to verify and describe clinical benefit and can be completed in a timely manner.
According to FDA, current law makes it difficult for the agency to take action when drug makers move too slowly on accelerated approval confirmatory studies. A statutory change would help provide greater assurance at the time of a drug product’s accelerated approval that the confirmatory study will progress in a timely manner and reap high-quality, interpretable results, FDA adds.
FDA’s accelerated approval pathway has been a major focus of lawmakers and policy watchers over the past year, spurred by FDA’s controversial approval of Biogen’s Alzheimer’s drug, Aduhelm. That drug’s approval, which was based on an unvalidated surrogate endpoint and scant evidence of efficacy, has highlighted key problems with the pathway, policy experts say.
FDA also proposes the dietary supplement law, the Dietary Supplement Health and Education Act (DSHEA), be amended to require supplement makers provide FDA with annual listings of individual dietary supplement products. The agency wants lawmakers to clarify FDA’s authorities over products marketed as dietary supplements to facilitate enforcement against unlawfully marketed products. According to FDA, these amendments would allow the agency to know when new supplement products are introduced, quickly identify dangerous or illegal products on the market, and take appropriate action to protect consumers when necessary.
In addition, FDA seeks legislation that would give the agency new authority over cosmetic firms and subject firms to registration fees, which would increase resources for FDA’s Cosmetic Safety Program. This proposal would require domestic and foreign cosmetic firms to register their establishments and list their products with the agency and require domestic and foreign cosmetic firms to report serious and frequently occurring adverse events to FDA. The cosmetics proposal also would provide explicit authority for FDA to promulgate good manufacturing practice regulations and to require that known cosmetic allergens be included in the ingredient list on the product label. Further, FDA also would be given mandatory recall authority for cosmetics that pose serious risks to public health.
FDA also requests more authority to request facility records or other information in advance or in lieu of inspections for dietary supplements, food, device, and tobacco product establishments. Under this proposal, FDA would be given authority to conduct remote, virtual regulatory assessments with dietary supplements, food, device, and tobacco product establishments, which may include live streaming video of operations, teleconferences, and screen sharing. FDA’s authority to conduct remote regulatory assessments is limited to requests for records and other information in advance or in lieu of drug inspections, and FDA currently lacks authority to require any establishment to participate in remote interactive evaluations
Lastly, FDA wants the authority to lengthen drug expiration dates, which it says could help mitigate shortages of critical drugs, including those that are life-supporting, life-sustaining, or used to prevent or treat debilitating diseases.