FDA CHANGES GENERIC DRUG POLICY TO ACCELERATE REVIEWS
The FDA is changing its generic drug review policy, abandoning its "first come, first served" approach when there is a potential public health risk to ensure that these submissions are not delayed, the agency said.
The FDA faces a growing workload that will likely lead to a backlog of abbreviated new drug applications (ANDAs), requiring an exception to long-standing agency policy, the FDA's Oct. 18 "Review Order of Original ANDAs, Amendments and Supplements" said. The FDA will consider expedited review for "products to respond to current and anticipated public health emergencies, products under special review programs such as the President's Emergency Plan for AIDS Relief, products for which a nationwide shortage has been identified and first generic products for which there are no blocking patents or exclusivities on the reference-listed drug."
If an ANDA does not qualify for this exemption, reviewers will continue to use existing review policies, which prioritize applications based on when they arrived and consider whether an amendment is major or minor, if it is an original application and other factors.
The Generic Pharmaceutical Association lauded the new policy as a means to ensure that the public has timely access to generic drugs.
The document is available at www.fda.gov/cder/mapp/5240-3R.pdf (http://www.fda.gov/cder/mapp/5240-3R.pdf).