The House Energy & Commerce Committee unanimously passed the Food and Drug Amendments of 2022, its version of the Food and Drug Administration’s user fee legislation on Wednesday. The bill combines aspects of both of the Democratic and Republican’s proposed bills, while nixing others. The bill allows the FDA to hire and maintain the personnel required to review drug applications and to evaluate the safety and efficacy of drugs.
Unlike bills that were previously proposed, the Food and Drug Amendments of 2022 provides a detailed method for expedited drug withdrawal procedures. To withdraw a drug from the market, the FDA will have to provide the drug sponsor with notice and an explanation as well as the opportunity to meet with the FDA. The FDA will also have to provide the drug sponsor a written appeal to the FDA, provide public notice and comment period for the proposed withdrawal, publish the comments received; and convene and consult an advisory committee to discuss the withdrawal.
This news comes in the wake of increased attention on the FDA’s accelerated approval process after Biogen, the maker of a controversial Alzheimer’s drug, announced last month it would cut back on marketing the product due to lack of sufficient data to support market authorization.
“Since its inception in 1992, FDA’s accelerated approval program has allowed earlier patient access to life-saving drugs that treat cancer, AIDS, and many other serious diseases and conditions,” according to a statement from the FDA.
Brittney Cafero, an associate at Reed Smith, who represents clients across the healthcare industry, said the new language passed Wednesday “continues the regime where the FDA can require post-approval studies,” although, there are some changes.
Those changes include requirements related to post-approval studies. For example, the FDA can waive the requirement for post-approval studies but it must publish the rationale for that decision on its website. Also, the FDA must specify the conditions for the post-approval study by the approval date for the drug and can require the studies to be underway prior to approval.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
It also provides for the ability of the FDA to withdraw approval as a result of drug companies not conducting the post-approval studies or if the studies fail to show the clinical benefits or other evidence shows that it is not safe or effective.
FDA data shows that 17 out of 125 total new drug approvals in 2021 went through the accelerated pathway. In total, 278 drugs have been approved through the accelerated approvals program’s inception in 1992.
The Food and Drug Amendments of 2022 will likely pass the House next, according to Cafero.
Earlier this week, the Senate HELP Committee drafted a proposed bill authored by Senator Patty Murray (D-WA) and Ranking Member Richard Burr (R-N.C.) to reauthorize all the different FDA user fees that doesn’t acknowledge the accelerated approval pathway, but there’s still time for it to be reviewed and added.
“Although the accelerated approval pathway improvements are not included in the [Senate] draft, that is not definitive that it will not be included in the final legislation,” Cafero said. “The accelerated approval improvements can either be added during Committee markup or added in an attempt to true up the bill to the one that is moving through the House right now.”
Comments on the Senate’s draft bill are due by Sunday.
