Alerts and Updates

FDA Implements Expedited Review of ANDA Submissions for "Sole-source" Drug Products

March 31, 2016

“Expedited review” means that a submission will receive heightened review priority as determined by the Office of Generic Drugs Division of Project Management staff and OGD management.

The U.S. Food and Drug Administration (FDA) recently updated its Manual of Policies and Procedures (MAPP) 5240.3 on Prioritization of the Review of Original ANDAs, Amendments and Supplements to Revision 2, adding a new category of expedited review of abbreviated new drug application (ANDA) submissions for “sole-source” drug products.

“Expedited review” means that a submission will receive heightened review priority as determined by the Office of Generic Drugs (OGD) Division of Project Management staff and OGD management. Expedited review may be granted following a request from the applicant or at the OGD’s initiative. If expedited review is requested, the statement, “Expedited Review Request,” should be placed prominently at the top of the submission. The submission should include the basis for the expedited review request. Submissions that do not receive expedited review will be reviewed in the order in which they are received, to the extent possible and unless otherwise determined by the FDA.

The FDA will determine the eligibility for the “sole-source” products category of expedited review based on the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”). To qualify for the “sole-source” category, an ANDA submission must be for drug products that have only one approved drug product listed in the Prescription Drug Product List (the “active section”) of the Orange Book. Additionally, the reference listed drug cannot have any blocking patents or exclusivities at the time of the request. Such a submission may receive expedited review.

However, a submission will not receive expedited review if the reference listed drug product was approved pursuant to a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act.

In addition to expedited review for ANDA submissions for sole-source products, in August 2014, the FDA previously prioritized review of ANDA submissions for the following categories:

  1. Submissions containing patent certifications pursuant to 21 CFR 314.94(a)(12). Primarily, potential first generic products for which there are no blocking patents or exclusivities on the reference listed drug may receive expedited review. Submissions that include a Paragraph IV certification, but become eligible for approval during the review period as a result of no blocking patents or exclusivities (including 180-day exclusivity) and no applicable stays, may receive expedited review if no other generic version of the same reference listed drug has been brought to market under an approved ANDA.
  2. Submissions related to drug shortages, including those that can help mitigate or resolve a drug shortage and prevent future shortages.
  3. Submissions that are subject to special review programs, such as the President’s Emergency Plan for AIDS Relief.
  4. Submissions related to public health emergencies, including those that can help address a public emergency declared by the Secretary of the Department of Health and Human Services, or those that are anticipated under the same criteria that apply to such a declaration.
  5. Submissions related to certain government purchasing programs, including expiration-date extensions or packaging changes usually requested by the Government-Wide Quality Assurance Program.
  6. Submissions subject to statutory mandates or other legal requirements.
  7. Supplements for which expedited review is requested under 21 CFR 314.70(b)(4) for public health reasons or if a delay in making the change described in the supplement would impose an extraordinary hardship on the applicant. 

Overall, the FDA will begin prioritizing ANDAs for generic drug submissions for which there is currently only one supplier and for which blocking patents or exclusivities do not exist. The expedited review will provide incentives to generic pharmaceutical companies for developing a generic version of a product that has only one competitor on the market. Such a policy is intended to increase competition and reduce drug shortage.

For Further Information

If you have any questions about this Alert, please contact Frederick (Rick) R. Ball, Jiazhong (Jason) Luo, Jordana A. Garellek, any member of the Pharmaceutical, Medical Device, Pharmacy and Food industry group or the attorney in the firm with whom you are regularly in contact.

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.