The upheaval at the Food and Drug Administration that started with a mass reduction in force on April 1 seems to be having ripple effects on how the agency applies its rules. In particular, pharmaceutical companies may encounter delays at several points as they develop drugs and run clinical trials.
Before a drug can be tested in people, its maker must submit an investigational new drug application (IND). This document outlines what the molecule is, how it will be manufactured, and lays out detailed plans for animal studies and clinical trials. It takes about a year and a half to get an IND decision, but that process is already dragging on. A delay in that phase could mean fewer early-stage human studies.
Researchers can speed up the approval process by applying for an accelerated review or breakthrough therapy designation. In the latter case, researchers can present early data that indicates the drug will be a significant improvement over existing treatments. Both paths require a lot of lab testing and clinical trials.
In addition, companies can apply for a label expansion if a successful treatment has been approved to treat another disease. If researchers can demonstrate the safety and efficacy of the drug in a second condition, the FDA will grant the request.
Investors are watching for signs that Makary’s leadership will influence what drug makers choose to develop and test. Hesselink says he fears that negative statements about vaccines, messenger RNA therapies, and weight-loss medicines will push some companies to focus on areas the agency has already targeted for caution.