CDER Revises MAPP on Prioritization Review of ANDAs

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CDER is now prioritizing review of generic drug products for which there is only one approved drug product on the market.

On March 11, 2016, the Center for Drug Evaluation and Research (CDER) released a revision of the Manual of Policy and Procedures (MAPP) on the Prioritization of the Review of Original ANDAs, Amendments, and Supplements. In the revision, CDER cites submissions for “sole-source” drug products as an additional circumstance under which abbreviated new drug applications (ANDAs) for new generic drugs may be prioritized.

In the revised MAPP, CDER says “submissions for drug products for which there is only one approved drug product listed in the Prescription Drug Product List of FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations and for which there are no blocking patents or exclusivities may receive expedited review.” This applies except where the approved drug product was approved “pursuant to a suitability petition.”

This comes after a House Oversight and Government Reform Committee hearing in early February 2016 that focused on hikes in drug prices. The committee called upon executives from Turing Pharmaceuticals, who raised the price of Daraprim (pyrimethamine) nearly 5000%, and Valeant, who raised the price of Nitropress (nitroprussid sodium) 212% and Isuprel (isoproterenol) 525%, to give reasoning for the price jumps.

Part of the issue, the committee noted, was a decrease in market competition, particularly for older drugs like Daraprim, the only available treatment for toxoplasmosis. Turing purchased the 62-year-old drug and later raised the price from $13.50 per pill to $750. The lack of generic equivalents for Daraprim, the committee said, allowed the company to monopolize the market and may force patients to pay high out-of-pocket costs.

Recently there has been a call for a faster review process of ANDAs by FDA, to prevent a single drug from monopolizing the market. In February 2016, Steven Ostroff, acting commissioner of food and drugs at FDA, published a blog for the agency on modernizing the generic-drug review process. Ostroff cited the Generic Drug User Fee Amendment (GDUFA) as a potential method for increasing patient access to affordable generics. He says the agency is working to improve the process and recently cleared an ANDA backlog of 1100 that had accumulated since August 2014.


The most recent revision to the MAPP may be an important step towards modernizing the generic-drug review process. Prioritizing review of generics drugs for which there is only one approved drug product listed may be a method of combatting the decrease in market competition. This may also speed up FDA review process of generics. In an email to Bloomberg Business, Sandy Walsh, a spokesperson for FDA said the agency expects the change in prioritization to expedite review of 125 generic drug applications. Whether or not the revision will have a significant impact on the ANDA review process is yet to be determined.

In another effort to improve generic review, FDA announced that it is holding a public hearing in May 2016 on regulatory science initiatives for generic drugs. The agency is asking for public input for the meeting, which it will take into account while developing the 2017 fiscal year Regulatory Science Plan.

Source: CDER