Congress Slowly Reforming FDA Accelerated Approvals, But With Pharma-Friendly Regulations

Congress Slowly Reforming FDA Accelerated Approvals, But With Pharma-Friendly Regulations

May 19th, 2022 // 9:34 pm @

As we previously reported, lawmakers in the House of Representatives are moving closer this month to cracking down on pharmaceutical companies that abuse the agency’s accelerated approval pathway, but the pending legislation is friendlier to the pharmaceutical industry than previous versions.

The House Energy and Commerce Committee announced in early May that the user fee authorization bill will have a new policy added by Rep. Frank Pallone (D-NJ) that makes it easier for FDA to take back its drug approval that was given through the accelerated pathway when the pharma company doesn’t finish the mandatory follow-up clinical studies.

FDA has an accelerated approval policy that lets FDA greenlight drugs without strong evidence that they help patients live longer. The fast-track approval process is always controversial, but those criticisms became much louder after the agency approval the Alzheimer’s drug Aduhelm made by Biogen, with the accelerated approval process.

Even the biggest supporters of the faster process say it’s wise to provide the agency with more power to punish companies who don’t do the follow-up trials in a reasonable period of time. At least 90 patient organizations wrote the legislators in Washington to argue that setting up clear guidelines when the withdrawal of an accelerated approval can be done. This, the patient groups say, is important for holding pharmaceutical companies accountable when they slip up.

The original bill would have revoked a drug approval as soon as the post-approval studies were one year late. But this provision has been deleted from the current draft.

The current bill also adds more steps FDA must take to rescind the accelerated approval. Before, FDA could take the approval by just contacting the company and allowing it to appeal, followed by opening the public docket to receive comments.

The new bill mandates that FDA has to meet with the pharma company at their request, answer all public comments, and FDA would need to call an expert panel on the matter if a sponsor asks for it.

The new bill also has language that lets the company support the follow-up studies with ‘real world’ evidence.

The reforms for the accelerated approval process are just one rider that is in this user fee bill. It involves about 50% of the agency’s operating budget. The bill must be passed by September 30.

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