Drug Competition Action Plan by FDA
This week the FDA released a decision to support generics and published the list of off-patent and off-exclusively branded drugs without generics.
“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. 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. “I am committed to continuing to pursue additional policy steps, under the FDA’s current authority, to help reduce the burden on patients who have a difficult time paying for the medicines they need,” - said FDA Commissioner Scott Gottlieb, M.D.
FDA is also going to review all the generic drug application for a product to guarantee their further appearance on the market as soon as possible. The FDA will continue to refine and update the list periodically to ensure continued transparency around drug categories where increased competition has the potential to provide significant benefit to patients.