Introduction: The Opioid Crisis
Every day in the United States, more than 130 people die after overdosing on opioids, such as prescription pain relievers, heroin, and fentanyl. These deaths are part of the ongoing, national opioid crisis. The federal government, at the highest levels, is taking action to address the opioid crisis.
In April 2019, Alex M. Azar, Secretary of Health and Human Services, or HHS, renewed a determination that a public health emergency exists nationwide as a result of the consequences of the opioid crisis. President Trump has initiated a multi-pronged Initiative to Stop Opioid Abuse and Reduce Drug Supply.
Recently, the U.S. Food and Drug Administration, or the FDA, approved the first generic naloxone hydrochloride nasal spray. Naloxone can reverse or block the effects of opioids and prevent deaths, if timely administered.
The FDA has also described action to help facilitate an over-the-counter, or OTC, naloxone product. As explained in the FDA's announcement: "When someone overdoses on an opioid, the person may lose consciousness and breathing may become shallow or stop. This can rapidly lead to death if there's no medical intervention." … "However, if naloxone is administered quickly, it can counter the overdose effects, usually within minutes." … "One potential way to improve access to naloxone is to make it available for over-the-counter (OTC) sale."
To encourage naloxone OTC development, the FDA developed two model Drug Facts Labels, or DFLs, containing easy to understand pictograms. A DFL is required for OTC drug products. The DFL for an OTC naloxone nasal spray can be found here.
Priority Review of ANDA Drug Products for Emergency Treatment of Opioid Overdose
Earlier this week, the FDA took a further step to help combat the opioid crisis by announcing that the agency would prioritize the review of abbreviated new drug applications, or ANDAs, for drug products indicated for the emergency treatment of known or suspected opioid overdose. The FDA's action is based on the Public Health Emergency prioritization factor in Manual of Policies and Procedures 5240.3, or MAPP 5240.3.
MAPP 5240.3 section 4, recites, in part, that submissions which "could help address a public health emergency declared by the Secretary of the U.S. Department of Health and Human Services … may receive a priority review." Priority review is defined as the "FDA will either (1) give a shorter goal date or (2) grant an expedited review."
Specifically, the FDA will prioritize the review of ANDA submissions for the following reference listed drugs (RLDs)—"approved drug products to which new generic versions are compared to show that they are bioequivalent"—found in the Orange Book:
- Narcan (naloxone hydrochloride) injection, NDA 016636
- Narcan (naloxone hydrochloride) nasal spray, NDA 208411
- Evzio (naloxone hydrochloride) auto-injector, NDA 205787
- Evzio (naloxone hydrochloride) auto-injector, NDA 209862
- Revex (nalmefene hydrochloride) injection, NDA 020459.
The FDA notes it will "prioritize the review of ANDA submissions that reference any of the aforementioned RLD's, with the goal of improving access to these crucial medications." The agency also makes important clarifications, including that: new ANDAs for the RLDs may be eligible for: "enhanced communication and support in the form of product development, pre-submission, and mid cycle review meetings" in addition to being eligible for priority review. These ANDAs "may also be eligible for increased assessment communications."
ANDAs that have been submitted for review and that reference the RLDs, starting with the next solicited amendment, may receive expedited review, and may be eligible for increased assessment communications.
Conclusion
Generic drug manufacturers submitting qualifying ANDAs should take advantage of the FDA's actions with the goal of getting on the market sooner.
Charles Andres contributed to the preparation of this WSGR alert.
