Drugs

Taxpayer Group Calls for More Relaxed FDA

David McFarland

— 1 min read
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The Koch-supported Taxpayers Protection Alliance has issued a report, Reforming the FDA: Saving Money, Saving Lives, calling on the agency to “pursue a series of reforms that, if enacted, would save consumers millions of dollars and millions of lives. Across all divisions of the agency, a more permissive approach will increase healthcare innovation and lower costs.”

The report says that with a $5.7 billion budget for FY 2019, the agency falls short in providing Americans adequate access to the products they need or want. “The prescription medication approval process remains languid and demands increasingly outdated statistical guidelines from drug sponsors,” the group asserts.

While FDA says that its medication approval process has been significantly streamlined, and consumers have access to a record number of novel drugs approved by expedited procedures,” the report says, “these improvements in NDA processing times mask a cumbersome clinical trials process that is an increasingly costly and stringent prerequisite to FDA consideration. Drug manufacturers have responded to tightened agency statistical standards by withdrawing experimental medications from clinical trials, and only send FDA the relatively few NDAs likely to pass final approval.”

According to the taxpayer group, the final FDA approval rate appears to be greater than 80%, even though medications’ probability of success from Phase 1 is likely below 15%. “Research demonstrates that this increased statistical stringency by FDA has likely cost more lives than it has saved,” the report says. “Based on disease cost burden and mortality data, the agency likely has too conservative a process for approving a majority of medications for oncology and various degenerative disorders.”

Recommendations in the report include: 

  •          finalize a 2010 draft guidance that acknowledged the benefit of alternative statistical approaches and consider clinical trial results that consistently approach the 95% confidence interval, even if they do not consistently meet that threshold;
  •          examine the feasibility of removing efficacy standards for new medications, shifting Phase 3 trials to the post-approval period and making them voluntary for medications that have demonstrated their safety to FDA; and
  •          tighten advisory committee waiver standards for conflicts of interest and set a committee vacancy target level of 0% rather than the current 10%.

The report also has recommendations for tobacco products and foods.

 

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