FDA Reform: Commonsense Fixes to the Drug Approval Process

Today, the Taxpayers Protection Alliance (TPA) released a report on the Food and Drug Administration (FDA)’s Drug Approval Process. Drug approvals are at their lowest since 2016 as developers spend $2 billion and roughly a decade to get a single product approved. TPA’s report addresses these shortcomings and provides evidence-based recommendations for reform.

The report’s recommendations include:

1. Embrace external controls
2. Evaluate clinical trial data by quality of empirics, not country of origin
3. Relegate manufacturing and logistics to post-approval monitoring

In announcing the report, TPA President David Williams, offered the following comment:

“TPA is hopeful this report will be a wakeup call that the FDA is failing patients with an approval process that works toward rejection and fails to consider unique benefits of a medication.

“The FDA has been dismissive of both external controls and clinical trials outside of the United States. The agency has also used manufacturing concerns to reject medications already approved elsewhere. There is no reason Americans should have greater access to cures outside of our borders.

“Congress should not be alarmed by the lowest approval rate since 2016 and recent uptick in complete response letters. TPA’s report includes empirical data and complete response case studies to help members of Congress understand the shortcomings of the current drug approval process. TPA hopes this report will lead to oversight and reform.”

 Read the full report below and here.