FDA to Prioritize Generic Drug Applications

FDA to Prioritize Generic Drug Applications

On Friday, the Food and Drug Administration (FDA) released its updated Manual of Policies and Procedures (MAPP) on the prioritization of abbreviated new drug applications (ANDA) by the FDA Office of Generics. In response, John Rother, executive director of the Campaign for Sustainable Rx Pricing issued the following statement:

“The pharmaceutical market is broken and a lack of competition and transparency keeps the market from functioning properly.  Recently, the FDA took an important first step in acknowledging the need to introduce more competition by prioritizing generic applications where there is no competition.  This effort will give patients better access to affordable treatments,” said John Rother, executive director of the Campaign for Sustainable Rx Pricing.  While FDA’s action will help improve the market for generic drugs, much more needs to be done to lower the price of brand drugs, which are the real driver of costs in the system.”