FDA to Prioritize Generic Drug Applications for ‘Sole-Source’ Products

The US Food and Drug Administration (FDA) on Friday announced it will begin prioritizing abbreviated new drug applications (ANDAs) for generic submissions for which there is currently only one manufacturer.

The change, which would effectively speed up the review of so-called "sole-source" generic drugs could increase competition, help with drug shortages and may even drive down the cost of expensive generics that have no competition. The change came in the form of an updated Manual of Policies and Procedures (MAPP) on the prioritization of ANDAs by FDA’s Office of Generic Drugs (OGD).

The update on the prioritization follows the introduction earlier this month of a Senate bill that would create a priority review voucher program that would reward companies for developing a generic with only one competing product on the market or on the FDA’s drug shortage list.

In addition to the prioritization of ANDAs for sole-source products, FDA has already prioritized:

• Potential first generic products for which there are no blocking patents or exclusivities on the reference listed drug;
• ANDAs related to drug shortages;
• ANDA submissions subject to special review programs, such as the President’s Emergency Plan for AIDS relief;
• ANDAs related to public health emergencies;
• Submissions related to certain government purchasing or procurement activities, including expiration-date extensions or packaging changes usually requested by the Government-Wide Quality Assurance Program;
• Submissions subject to statutory mandates or other legal requirements; and
• Supplements for which expedited review is requested under 21 CFR 314.70(b)(4).

Under the update, FDA says: “Submissions for drug products for which there is only one approved drug product listed in the Prescription Drug Product List (the ‘active section’) of FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the ‘Orange Book’) and for which there are no blocking patents or exclusivities may receive expedited review, except where the approved drug product was approved pursuant to a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act.”

Submissions that do not receive expedited review will be reviewed in the order in which they are received, FDA says.

OGD Division of Project Management staff, supervised by OGD management, will have overall responsibility for applying the prioritization policy outlined in this MAPP.

The MAPP was also updated to reflect the reorganization of CDER’s Office of Pharmaceutical Quality and to revise certain forfeiture timeframes consistent with the Food and Drug Administration Safety and Innovation Act of 2012.

Prioritization of the Review of Original ANDAs, Amendments, and Supplements