FDA Considering Removing Regulatory Obstacles to Generic Competition

Mid-July 2017, the United States Food and Drug Administration held a public meeting to discuss options and steps to encourage innovation in drug development and accelerate consumer access to generic drugs. FDA believes that attempting to strike such a balance will speak to Congress’ initial intent when it enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments).  FDA Commissioner Scott Gottlieb opened the meeting with a discussion of the Agency’s position and the announcement of the intended 2017 release of two new documents to improve the generic approval process as part of his Drug Competition Action Plan announced earlier this year. The first document, a Good ANDA Assessment Manual of Policy and Procedures (MaPP), will be an internal CDER policy to streamline the ANDA review process inside FDA without lowering approval standards. As part of this MaPP, Complete Response Letters will make clear what aspect of the application needs improvement to obtain approval. The second document is a Good ANDA Submission Practices Guidance, which will point out common recurring deficiencies in ANDA and provide advice on avoiding them in an effort to ensure better higher quality submissions. During the meeting, several of the participants discussed the effect of patent and exclusivity periods, regulatory review timelines, insurance reimbursement practices, the number of generic competitors and timing of generic ent...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs