After a 20% reduction in force on April 1 that excluded many drug, device, and food reviewers, and a few weeks after the resignation of former Commissioner Robert Califf, speculation was rampant about how the FDA would function under its new leadership. But according to some pharmaceutical industry insiders, the agency’s work seems to have continued without any major delays.
For drug companies, the FDA sets regulatory guidelines at multiple junctures as they develop a new medicine and run clinical trials. One of the most important junctures is when they prepare an investigational new drug application, which details what a company is developing and how it plans to test its safety in humans. FDA reviewers typically refer to these policies throughout the approval process. But the offices that develop these guidance documents were also among those affected by the layoffs, leaving a vacuum in technical decision-making that could lead to delays.
The agency has also issued a few new drug-specific guidance documents, which are a critical tool for generic manufacturers to help them speed up the approval process. But Tenbarge says these new documents lack detailed explanations about how generic makers can prove that their drugs are equivalent to the original medicines, leading to unnecessary delays.
In other approval news, a study of cancer drugs approved through the Accelerated Approval pathway found that 63% were converted to regular approval after more than five years and that 43% demonstrated clinical benefit in confirmatory trials. This trend is important to monitor, especially given CMMI’s dim view of these drugs and proposals to significantly reduce Medicare reimbursement through the Medicare Drug Price Negotiation Program.