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FDA Revamps Policy for Prioritizing Generic Drug Applications in Effort to Widen Access


In an effort to speed more generic drug approvals, the FDA said it is changing how it assigns priority review status to abbreviated new drug applications.

The FDA released another set of changes this week, this time changing how abbreviated new drug applications (ANDAs) are prioritized for review so that the agency’s resources are allocated to generic drugs that would have the biggest impact on public health.

Before, “roughly half of all ANDA submissions were designated as priority submissions, including many products that could not be marketed for several years as a result of blocking patents or exclusivities,” according to Sally Choe, PhD, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research.

Under the previous version of the Manual of Policies and Procedures (MAPP) 5240.3, Prioritization of the Review of Original ANDAs, Amendments, and Supplements, the FDA prioritized submissions from first filers and from applicants with paragraph IV certifications, even though the drugs would not be able to come to market for years due to a patent, 30-month stay, or exclusivity blocking final approval. A paragraph IV certification is a generic applicant’s assertion that the brand-name product’s patents listed in the Orange Book are invalid, unenforceable, or will not be infringed by the proposed generic product.

This did not improve generic drug access, the FDA said; wider access could have the effect of “potentially lowering costs by expediting the availability of safe, high-quality, effective generic medicines in areas of the market with limited competition,” said Choe.

Under the change, an original ANDA must meet certain criteria in order to have a priority review. Those include:

  • An explicit request from the applicant at the time of submission that includes the prioritization factor or factors under which the applicant believes the submission qualifies for priority review
  • The FDA determines that the submission relates to a drug shortage or public health emergency.

Among other things, prioritization factors include:

  • Submissions for which there are not more than 3 approved drug products
  • Applications containing a paragraph IV certification
  • Submissions for which final approval is dependent on the expiration of a patent or NDA exclusivity
  • Submissions for “sole source” drug products

The change applies to both regular generic drugs as well as complex generics, which generally mean drugs with complex active ingredients, complex formulations, complex routes of delivery, or complex dosage forms.

Separately, the House Energy and Commerce Committee made a bipartisan request earlier this month to FDA Commissioner Stephen Hahn, MD, asking for additional information about the approval process for complex generic drugs. According to the letter, the representatives want information about whether the agency’s “initiatives and commitments are sufficient to address the particular challenge of approving complex generic drugs” and to find out if “additional authority is needed to improve the approval process for complex generic drugs to increase access and reduce costs.”

Among other things, the committee asked for a list of list of all complex generic drugs approved by FDA since October 1, 2016, including the date of the first submission, the dates of other milestones and the date of approval, and the number of pre-ANDA meeting requests that FDA has received each year since the program was launched, the number of pre-ANDA meetings that FDA has held each year, and. the number of ANDAs that have been submitted for products discussed during these meetings.

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