House Energy and Commerce Committee unanimously passed Food and Drug Amendments of 2022, its version of the Food and Drug Administration’s user fee legislation Wednesday. The bill combines aspects of the bill proposed by Democrats and Republicans while negating others. The act allows FDA to hire and maintain the personnel necessary to review drug applications and evaluate drug safety and efficacy.
Unlike previously proposed bills, the 2022 Food and Drug Amendments provide detailed ways to expedite the drug withdrawal process. To withdraw a drug from the market, the FDA must provide the drug sponsor with a notice and explanation, as well as an opportunity to meet with the FDA. FDA must also provide the drug sponsor with a written appeal, provide a notice and comment period for the proposed withdrawal, publish comments received; convene an advisory committee to discuss the appropriate withdrawal.
The news comes after Biogen’s increased focus on the FDA’s accelerated approval process, The maker of a controversial Alzheimer’s drug, It was announced last month that it would cut marketing The product lacks sufficient data to support market authorization.
“Since its inception in 1992, the FDA’s Accelerated Approval Program has allowed early-stage patients access to life-saving medicines for cancer, AIDS and many other serious diseases and conditions,” according to a statement from the FDA.
Brittney Cafero, a partner at Reed Smith who represents clients across the healthcare industry, said the new language passed Wednesday “continues the system by which the FDA can request post-approval studies,” albeit with some changes.
These changes include requirements related to post-approval studies. For example, the FDA can waive the requirement for post-approval studies, but must publish the rationale for that decision on its website. In addition, the FDA must specify conditions for post-approval studies prior to the drug’s approval date, and can require studies to be conducted prior to approval.
It also stipulates that the FDA can withdraw approval because the drug company has not conducted post-approval studies, or studies have failed to show clinical benefit or other evidence that it is not safe or effective.
Of the 125 new drugs approved in 2021, 17 passed the accelerated pathway, FDA data shows. A total of 278 drugs have been approved since the accelerated approval program launched in 1992.
Carvero said the 2022 food and drug amendments will likely pass the House of Representatives next.
Earlier this week, the Senate Help Committee drafted a Proposed Bill author: Senator Patty Murray (D-WA) and Ranking member Richard Burr (RN.C.) reauthorized all of the various FDA user fees that do not recognize the accelerated approval pathway, but there is still time to review and add them.
“While improvements to the accelerated approval pathway are not included in the [Senate] Draft, not sure it will be incorporated into the final legislation,” Caero said. “The accelerated approval improvements could be added during committee marking or to try to align the bill with the bill currently passing through the House. ”
Comments to the Senate draft bill Expires on Sunday.
