Drugmakers consult FDA policies at multiple junctures as they design their drugs, run trials, and apply for approval. Upheaval at the agency since April 1 – including mass layoffs and a lack of informal guidance – has some observers worried about how it might affect the regulatory process.
Before testing their drugs in humans, researchers prepare an investigational new drug application (IND). They must also ask regulators specific technical questions, which can sometimes be lengthy if the research is complex. A longer wait time for these early meetings could put the brakes on drug development, says Hesselink. “The companies that have limited capital need to get to human data as quickly as possible so they don’t spend a year and a half burning their money before getting approved.”
Once a company has the clinical trial results it needs, it can submit a new drug application (NDA) or biologics license application (BLA) for FDA review. If the drug receives priority review, the FDA can make a decision within 10 months of accepting the application. Otherwise, it takes about a year for the FDA to complete a standard review.
Several new drugmakers may seek accelerated approval of their therapies this year. These are drugs that are based on first-in-class mechanisms of action and can help treat diseases with few effective treatments. For example, rezdiffra (selective cholinesterase inhibitor) for schizophrenia and cobenfy (drug that targets cholinergic receptors to treat Alzheimer’s disease) are both expected to receive this designation.