Illustration: Tiffany Herring/Axios
An HHS inspector general's report raises new concerns with the FDA's accelerated approval process, which has received increased scrutiny in recent Congresses.
Why it matters: Concerns over the expedited pathway stem in large part from the agency's controversial approval of the Alzheimer's drug Aduhelm. The new report examines whether there are similar concerns with other drugs given fast-track reviews to fill unmet needs.
Driving the news: The IG identified three out of 24 accelerated drug approvals reviewed that raised concerns, suggesting that problems do not permeate all the approvals, but that there are still issues to be addressed.
- Those three drugs are Biogen's Aduhelm, Sarepta's Exondys 51 for Duchenne muscular dystrophy and Covis' Makena for preterm birth.
- The concerns raised include approving the drugs despite concerns from FDA advisory committees or agency reviewers, and not properly documenting meetings with manufacturers of the drugs.
- Aduhelm and Makena were subsequently pulled from the market.
What's next: Congress passed new legislation aimed at reforming the process at the end of 2022.
- Part of that legislation established a council within the FDA to review the accelerated approval process.
- The IG recommends that FDA define specific factors that would require the council to get involved in a drug's approval.
- It also says FDA should take steps to ensure that meetings with drug company sponsors are properly documented.
The bottom line: The IG report states that oversight is important because "there is risk that an accelerated approval drug will not ultimately provide a clinical benefit for patients, necessitating safeguards and transparency in FDA decision making."
