Doctor concerned with health care law

Breaking news and expert analysis on legal and compliance issues

[Back To Home][Back To Archives]

From Health Law Daily, March 11, 2019

FDA helps broaden access to naloxone with model label for non-prescription use

By Leah S. Poniatowski, J.D.

FDA satisfied with independent study results, releases models of drug facts labels for stakeholders pursuing non-prescription approval of opioid antagonist.

In an effort to help stem the opioid crisis, the FDA has made model drug facts labels available for naloxone, an opioid antagonist, allowing sponsors to seek non-prescription approval and make the drug more widely available (Notice, 84 FR 8728, March 11, 2019).

Background. Following an opioid overdose, the respiratory and central nervous systems become depressed to life-threatening levels. Naloxone is a prescription opioid antagonist and, if timely administered, can save the life of someone experiencing an overdose. In light of the public health crisis presented by the increased misuse and abuse of illicit and prescription opioids, the FDA recognizes that making naloxone more broadly available can help stem the deaths from overdoses. At present, naloxone is only available by prescription and must be approved for non-prescription use.

Behavioral studies. In order for a prescription drug to be approved for non-prescription use, the drug sponsor must conduct consumer behavior studies to ensure the safety and efficacy of the drug without professional supervision. With respect to naloxone, some sponsors have indicated that the study requirement presents a burden to develop the nonprescription version of the drug. In response, an independent research contractor undertook a 700-person study of label comprehension using two FDA-created model drug facts labels, reflecting the two methods of administration: nasal spray and injector. An FDA team separate from the label development group concluded that the label comprehension study results were adequate and that the labels can be used. Sponsors interested in marketing non-prescription naloxone can base their label on the models and add device-specific information. Sponsors would need to retest label comprehension thereafter.

FDA interaction. Sponsors interested in developing nonprescription naloxone are strongly encouraged by the FDA to contact the Division of Nonprescription Drugs Products to request a meeting concerning their drug development programs.

MainStory: TopStory Notices FDCActNews DrugBiologicNews LabelingNews SafetyNews

Back to Top

Health Law Daily

Introducing Wolters Kluwer Health Law Daily — a daily reporting service created by attorneys, for attorneys — providing same-day coverage of breaking news, court decisions, legislation, and regulatory activity.

A complete daily report of the news that affects your world

  • View full summaries of federal and state court decisions.
  • Access full text of legislative and regulatory developments.
  • Customize your daily email by topic and/or jurisdiction.
  • Search archives for stories of interest.

Not just news — the right news

  • Get expert analysis written by subject matter specialists—created by attorneys for attorneys.
  • Track law firms and organizations in the headlines with our new “Who’s in the News” feature.
  • Promote your firm with our new reprint policy.

24/7 access for a 24/7 world

  • Forward information with special copyright permissions, encouraging collaboration between counsel and colleagues.
  • Save time with mobile apps for your BlackBerry, iPhone, iPad, Android, or Kindle.
  • Access all links from any mobile device without being prompted for user name and password.