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FDA Statement

Statement from FDA Commissioner Scott Gottlieb, M.D., on unprecedented new efforts to support development of over-the-counter naloxone to help reduce opioid overdose deaths

For Immediate Release:
Statement From:

With the number of overdose deaths involving prescription and illicit opioids more than doubling over the last seven years to nearly 48,000 in 2017, it’s critical that we continue to address this tragedy from all fronts. This includes new ways to increase availability of naloxone, a drug used to treat opioid overdose.

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. While the person administering naloxone should also seek immediate medical attention for the patient, the bottom line is that wider availability of naloxone and quick action to administer it can save lives.

Naloxone is a critical drug to help reduce opioid overdose deaths. Prevention and treatment of opioid overdose is an urgent priority. Increased availability of naloxone for emergency treatment of overdoses is an important step. One potential way to improve access to naloxone is to make it available for over-the-counter (OTC) sale. FDA-approved versions of naloxone currently require a prescription, which may be a barrier for people who aren’t under the care of a physician or may be ashamed or even fearful of admitting to issues with substance abuse. Having naloxone widely available, for example as an approved OTC product, is an important public health advance, and a need that we’ve been working on at the FDA.

Although FDA-approved prescription naloxone formulations have instructions for use in product labeling, 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 must develop a DFL and conduct studies to show that consumers can understand how to use the product without the supervision of a health care professional. Some stakeholders have identified the requirement to perform these studies as a barrier to development of OTC naloxone products.

To encourage drug companies to enter the OTC market and increase access to naloxone, the FDA took an unprecedented step: we developed a model DFL with easy-to-understand pictograms on how to use the drug. We also conducted label comprehension testing to ensure the instructions were simple to follow.

This is the first time the FDA has proactively developed and tested a DFL for a drug to support development of an OTC product. We proactively designed, tested and validated the key labeling requirements necessary to approve an OTC version of naloxone and make it available to patients. One of the key components for OTC availability is now in place. In short, we’ve crafted model labeling that sponsors can use to obtain approval for OTC naloxone and increase its access. This action was part of our broader commitment to addressing the opioid crisis.

Today, we’re announcing the results of our work, including posting two model DFLs (one for use with a nasal spray and one for use with an auto-injector) and the supporting FDA review. These efforts should jumpstart the development of OTC naloxone products to promote wider access to this medicine. The model DFL contains the information (except for individual product-specific information) that a consumer needs to administer naloxone safely and effectively.

During this period without a FY19 appropriation for the FDA, we’ve been focused on making sure that we continue critical aspects of our work, to the extent permitted by law. At this time, for products (such as naloxone) that are covered by a user fee program, our review of existing medical product applications and associated policy development regarding our review are funded by limited carryover user fee balances. We’ll continue to update the public on how we’re approaching our work during the lapse in appropriations.

Consumer comprehension of the model DFL was iteratively tested by an independent research contractor in a prespecified research design involving over 700 participants across a wide range of potential OTC naloxone users. This included people who use heroin; people who use prescription opioids; family and friends of people who use opioids; adolescents; and the general public. An FDA review team not directly involved in the conduct of the study independently reviewed the study report and determined that the comprehension results were satisfactory. Overall, the study demonstrated that the model DFL was well-understood by consumers and is acceptable for use by manufacturers in support of their OTC naloxone development programs. Using this information, naloxone manufacturers can now focus their efforts on final label comprehension testing of how well consumers understand the product-specific information that hasn’t been already tested in the model DFL. I personally urge companies to take notice of this pathway that the FDA has opened for them and come to the Agency with applications as soon as possible.

The model DFL comes in two versions. One is for use with a nasal spray and one for use with an auto-injector. But the product-specific instructions in each version are placeholders that have not been tested by the FDA for comprehension or human factors performance. Sponsors can replace these placeholders with their own product-specific information and test it if necessary. Apart from this product-specific information, the model DFL otherwise contains all the key information needed for an untrained bystander to administer naloxone. In designing the model DFL, the FDA team sought input from multiple stakeholders in the addiction care community, as well as from the FDA internal experts, to streamline the DFL to contain only the most critical information, so that it could be easily understood in an emergency. We’re grateful to the hundreds of study participants who helped us see this DFL through their eyes, which enabled us to refine the DFL multiple times until we reached a final version. These research participants enabled these efforts.

This work builds on our ongoing efforts to get this life-saving drug into the hands of those who need it most. In addition to the approval of injectable naloxone for use in a health care setting and both prescription auto-injector and intranasal forms of naloxone, which facilitate use by laypersons, we also released draft guidance to advance development of generic naloxone hydrochloride nasal spray.

Additionally, we also held a two-day advisory committee meeting last month to solicit input and advice on strategies to increase the availability of naloxone products intended for use in the community. We asked 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.

As part of HHS’ ongoing efforts to combat the opioid crisis and expand the use of naloxone, in April 2017, the Department announced its 5-Point Strategy to Combat the Opioids Crisis. Those efforts include: better addiction prevention, treatment, and recovery services; better data; better pain management; better targeting of overdose reversing drugs; and better research. In April 2018, Surgeon General VADM Jerome Adams issued an advisory encouraging more individuals, including family, friends, and those who are personally at risk for an opioid overdose to carry naloxone. In December 2018, Adm. Brett P. Giroir, MD, Assistant Secretary for Health and the Secretary’s Senior Advisor for Opioid Policy, released guidance for health care providers and patients detailing how naloxone can help save lives.

We’re taking many steps to improve availability of naloxone products and we’re committed to working with other federal, state and local officials; health care providers; patients; and communities across the 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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Sarah Peddicord

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