FDA Statement on Efforts to Increase Availability of all Forms of Naloxone

Addressing opioid overdose continues to be one of the most urgent public health priorities for the U.S. government and making potentially lifesaving treatments more readily available is one of the top ways we can address this crisis. As we observe Prescription Opioid and Heroin Epidemic Awareness Week, a time when we acknowledge the devastating toll the opioid crisis has inflicted on our country, we felt it was essential to clarify important information about naloxone, an emergency opioid overdose reversal treatment. Naloxone is a critical tool for individuals, families, first responders and communities to help reduce opioid overdose deaths.

Access to naloxone, however, continues to be limited in some communities. There are three FDA-approved forms of naloxone – injectable, auto-injector and nasal spray – and all three currently require a prescription, which can be a barrier for people who aren’t under the care of a health care provider or who are apprehensive about admitting to issues with substance abuse. However, in response to the crisis, most states and the District of Columbia have passed laws that allow pharmacists to dispense naloxone under a standing order, which takes the place of an individual prescription. Some states also have given pharmacists direct authority to prescribe and sell naloxone to consumers. Still, many pharmacists may be unaware of the standing orders and direct authority in their states or are unwilling to provide all forms of naloxone to consumers without an individual prescription.

There is also a persistent misunderstanding that the FDA-approved labeling for the injectable form of naloxone, the least expensive option, precludes administration outside a health care setting. This has created confusion among public health officials and community-based organizations about whether the injectable form of naloxone can be used as part of their distribution programs. The FDA-approved product labeling for the three forms of naloxone does not exclude dispensing by pharmacies or community distribution programs. All three forms of naloxone are FDA-approved and may be considered as options for community distribution and use by individuals with or without medical training to stop or reverse the effects of an opioid overdose.

The FDA is working with other federal, state and local officials as well as health care providers, patients and communities across the country to increase availability of all forms of naloxone and combat the toll to communities, individuals and the economy resulting from opioid abuse and addiction. As we continue to confront the opioid crisis, several efforts are underway at the FDA to make naloxone more readily available and accessible.

In April, we approved the first generic naloxone hydrochloride nasal spray, a generic of the brand product, Narcan. The FDA is also granting priority review to all generic applications for products that can be used as emergency treatment of known or suspected opioid overdose. As part of the priority review, sponsors will receive shorter goal dates or standard goal dates with earlier reviewer deadlines; enhanced agency communication with sponsors; and expanded agency engagement, such as pre-submission and mid-cycle meetings.

Making naloxone more widely available in every pharmacy as an approved over-the-counter (OTC) product would also be an important public health advancement – one we have been working on at the FDA. In January, we took an unprecedented step in helping to encourage development of OTC naloxone products. To encourage drug companies to enter the OTC market, the FDA designed, tested and validated the key labeling requirements necessary to approve an OTC version of naloxone. To do this, we developed a model Drug Facts label (DFL) with pictogram instructions so anyone with access to the drug can better understand how to administer it. To ensure the pictograms are easy to understand, we also conducted label comprehension testing with consumers. This was the first time the FDA proactively developed and tested a DFL to support development of an OTC product.

With one of the key components for OTC availability now in place, drug companies can use this information as part of an application to obtain approval for OTC naloxone. We are continuing to work with industry partners who are interested in developing these OTC naloxone products.

The FDA also held a public meeting in December 2018 on various options for increasing access to naloxone, weighing logistical, social and economic aspects of this important issue. There was overwhelming support from meeting participants to remove barriers to obtaining naloxone, particularly OTC naloxone, and to support community activities that expand its availability. As a result, we are currently exploring more ways to increase the availability of all forms of naloxone, such as working with manufacturers to see if shelf-life extensions for naloxone products are possible; conducting additional research on naloxone; and considering situations where co-prescribing of naloxone may be appropriate including possible updated product labeling.

The U.S. Department of Health and Human Services has ongoing efforts to fight the opioid crisis and expand the use of naloxone. In April 2017, the department announced a 5-Point Strategy to Combat the Opioids Crisis, including better targeting of overdose reversing drugs. 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 Giroir, M.D., Assistant Secretary for Health and the Secretary’s Senior Advisor for Opioid Policy, released guidance for health care professionals and patients detailing how naloxone can help save lives

Ultimately, the goal of increasing access to all forms of naloxone is to make this potentially life-saving treatment available to individuals at risk of an overdose – such as those with a history of overdose or substance use disorder – and those in the community most likely to observe an overdose. The FDA remains committed to using its regulatory authority to address this crisis, working with all our partners to expand the availability of all forms of naloxone, and encouraging prescribers and patients to discuss this topic. All together, these efforts have the potential to put a vital tool for combatting opioid overdose in the hands of those who need it most – friends and family of opioid users, as well as first responders and community-based organizations.

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