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FDA Statement

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to advance new ways to increase the availability of naloxone as one means for reducing opioid overdose deaths

For Immediate Release:
Statement From:
Scott Gottlieb, M.D.

With the number of overdose deaths from prescription and illicit opioids doubling from 21,089 in 2010 to 42,249 in 2016, it’s critical that we continue to tackle this human tragedy from all fronts – including, and importantly, looking at new ways to increase the availability of naloxone.

This potentially life-saving treatment is a critical tool for individuals, families, first responders and communities to help reduce opioid overdose deaths. We recognize that emergency treatment of known or suspected opioid overdose is an urgent public health priority. And to advance these efforts, there is still a need to improve access to naloxone.

To that end, we’re announcing today an upcoming two-day advisory committee meeting in December to solicit input and advice on strategies to increase the availability of naloxone products intended for use in the community.

At this meeting, we’ll be asking our external advisors from the FDA’s Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management Advisory Committees to consider various options for increasing access to naloxone. They will help us weigh logistical, economic and harm reduction aspects of different strategies. And we will consider whether naloxone should be co-prescribed with all or some opioid prescriptions to reduce the risk of overdose death.

There is the potential for significant costs and burdens that may be associated with naloxone co-prescribing. These include the direct economic costs to consumers and health systems. They also include practical considerations such as the need for manufacturing volume growth for naloxone, and the risk of drug shortages of this product that could come from a sudden spike in prescribing.

The committee will be asked to evaluate these and other considerations, as part of our effort to consider any potential challenges to wider co-prescribing of naloxone for all or some prescription opioid patients.

December’s public meeting builds on the ongoing work that we’ve undertaken to get this life-saving medication into the hands of those who need it most. When someone overdoses on an opioid, it can be difficult to awaken the person and breathing may become shallow or stop. This can lead to death if there is no medical intervention.

But, if naloxone is administered quickly, it can counter the overdose effects, usually within minutes. Naloxone can save lives. But it’s not a substitute for immediate medical care for a patient who is overdosing on an opioid. Moreover, the person administering naloxone should seek further immediate medical attention on the patient’s behalf.

We’ve been working hard to improve the availability of naloxone products.

In addition to the approval of injectable naloxone for use in a healthcare setting and both prescription auto-injector and intranasal forms of naloxone, which facilitate use by laypersons, we’ve also released draft guidance for industry to facilitate the development of generic naloxone hydrochloride nasal spray.

We’ve also made progress on our work to advance the development of an over-the-counter (OTC) naloxone product as a way to promote wider access to this medicine. Although the auto-injector and nasal spray formulations have instructions for use, they don’t have the consumer-friendly Drug Facts Label (DFL), which is required for OTC drug products. Before submitting a new drug application or supplement for an OTC drug product, companies need to develop this DFL and conduct the required studies to show that consumers can understand how to use the product without the help of a health care professional. We recognized the important public health opportunity to bring naloxone OTC. So, to further encourage companies to enter this space, the FDA created a model DFL and simple pictogram. And we are in the process of conducting label comprehension testing for this product. This is the first time the FDA has proactively developed this OTC framework for a drug as a way to help activate the advance of OTC products. Using this information, naloxone manufacturers could focus their efforts on final label comprehension testing of how well consumers understand product-specific information that hasn’t been already tested on the more general model DFL. We plan to release the results of this work soon.

We plan on discussing the potential development of OTC naloxone at the upcoming meeting. Another topic we plan to discuss is the work that many organizations and local municipalities across the U.S. have done to develop programs for making naloxone available in the community. We hope to glean insight from these efforts to further our own goals at expanding naloxone availability.

We look forward to this important discussion on ways to make naloxone more available to treat opioid overdose. And we are committed working with other federal, state and local officials, health care providers, patients and communities across this country to combat the staggering human and economic toll created by opioid abuse and addiction.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Michael Felberbaum

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