The U.S. Food and Drug Administration will soon prioritize and review generic emergency opioid overdose treatments, along with any other generic drug submissions that fit under any of their requirements. These submissions could receive either a shorter goal date or an expedited review.

An Overview

This recent change in policy differs from the 2006 review procedures where the FDA had a “first in, first reviewed” approach. Now, they aim to prioritise abbreviated new drug applications (ANDAs) so that consumers can have better access to generic, life saving drugs.

If an ANDA, amendment, or supplement meets any of the prioritization requirements, they are eligible for priority review, where they receive shorter goal dates or get an expedited review.

Prioritization Requirements

  • Submissions must not have more than three approved drug products listed in the “Orange Book” (Approved Drug Products with Therapeutic Equivalence Evaluations), and they must also not have any blocking patents
  • Submissions that would mitigate, resolve, or prevent drug shortages
  • Those in special review programs (such as the President’s AIDS relief program)
  • Submissions related to public health emergencies
  • Drugs related to government purchasing programs
  • Submissions that are subject to legal requirements or mandates
  • For those who, if their applications are delayed, will face extraordinary hardships relating to unforeseen catastrophic events
  • Submissions for “sole source” drugs

For more detailed requirements, click here.

Procedures

The Office of Generic Drugs (OGD) will be responsible for coordinating, and applying this new policy. Those companies who submitted a prioritization request will be identified and reviewed. All other submissions would be assessed for prioritization purposes at the time they are submitted. 

Submissions that meet requirements for prioritization by the OGD and the OPQ (Office of Pharmaceutical Quality) will be notified.

The FDA will only consider the submission a prioritization request if the cover letter clearly states “Priority Review Requested” and has the ANDA number written. The submission should also have supporting documents attached to the request.

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