The FDA is a key factor in the development of new pharmaceutical treatments. 2024 saw significant approvals in oncology innovation, rare diseases, and first-in-class therapies that can redefine how drugs work. Keeping up with drug approval news is vital for pharmacies looking to optimize benefit strategies.
But the upheaval in the US Food and Drug Administration (FDA) since an April 1 reduction in force and voluntary buyouts removed thousands of staffers has left observers wondering if that upheaval could lead to delays in FDA drug-approval decisions. That’s because the FDA is involved in drug development at multiple junctures, and a loss of technical decision-making could ripple through the system.
One area of concern is the accelerated review program launched earlier this year by FDA Commissioner Dr. Makary, who aims to speed up the approval process for drugs that address urgent or life-threatening medical conditions. In an early example, the FDA granted priority review for Pergoveris, an injectable fertility drug already sold in Europe to help lower IVF costs for American families. It also approved JOURNAVX, an oral, non-opioid NaV1.8 pain signal inhibitor that’s a potential competitor to the more popular ketamine anesthetic.
But experts worry that the turbulence in the agency is affecting other areas of drug-approval decision making, including generics and drugs that target unmet medical needs. They warn that without the formal guidance documents that the FDA provides at these junctures, companies might be unclear on what they need to do to submit their applications. And without senior leadership stepping in to clarify the agency’s position, they may waste time on submissions that might otherwise be approved quickly.
About the Author
