FDA releases plan to expedite, promote generic drug development

As part of its effort to increase competition in the prescription drug market, the FDA released a list of drugs that are off-patent and off-exclusivity without approved generics and produced a revised manual of policies and procedures for review of abbreviated new drug applications, including prioritization for generic products.“No patient should be priced out of the medicines they need, and as an agency dedicated to promoting public health, we must do our part to help patients get access to the treatments they require,” Scott Gottlieb, MD, commissioner of the FDA, said in an agency press release. “Getting safe and effective generic products to market in an efficient way, being risk-based in our own work and making sure our rules aren’t used to create obstacles to new competition can all help make sure that patients have access to more lower-cost options.”