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FDA

Published On November 3, 2016

POLICY

The Patchwork Quilt of Naloxone Laws

A drug that reverses overdoses saves thousands of lives. Does its prescription status keep it from saving more?

Drug-related overdoses in the United States have reached an all-time high, and opioids are the main culprits. Heroin, prescription pain relievers and other opioids were involved in more than 60% of all drug overdose deaths in 2014, and the number of those deaths has tripled since 2000.

Naloxone is a major tool in saving those lives. The drug, in use since the 1970s, quickly throws an opioid overdose into reverse. But naloxone remains a prescription drug, which has made it tricky to use in an emergency. Possessing a prescription drug that was not prescribed to you is generally illegal for everyone but a medical professional, and so is administering it to anyone who doesn’t have a prescription. The first people at the scene of an overdose, however, are most often non-medical personnel—friends, passersby, police officers and others who work with heavy drug users.

In the mid-1990s, a handful of advocates began to bend the prescription laws, giving intravenous drug users “take-home” kits that contained injectable forms of naloxone that could be used to save their lives. Instead of prosecuting those workers, states have increasingly engaged in legal workarounds to protect them. New Mexico became the first state to make it easier for laypeople to administer the drug without fear of legal repercussions. As of June 2016, all but three states have passed legislation designed to make naloxone more available. In many states, this happened in conjunction with another workaround called a standing order, in which the state’s medical director issues a “prescription” that anybody who happens to be in the state can fill.

Now some advocates are pushing for a more straightforward fix: making naloxone an over-the-counter drug in the United States. Since 1976, more than 100 drugs have made the so-called Rx-to-OTC switch, including intranasal steroids (Flonase) and emergency contraceptives (Plan B). In 2012 and 2015, at the height of the opioid epidemic, the Food and Drug Administration held public workshops to discuss making this life-saving drug available over the counter.

The idea has been met with opposition. Regulatory officials are worried that increasing the availability of naloxone might give the impression of encouraging opioid misuse, while others wonder whether naloxone itself could be abused. Making naloxone OTC would “short-circuit doctor-patient relations,” says John Dombrowski, director of the Washington Pain Center, who spoke at the workshops. “These individuals have an addiction. They need to get help and advice.”

But advocates for the OTC designation have countered that naloxone is non-addictive. And though there are risks to consider, a patient who overdoses and dies of respiratory failure has no chance to recover from drug dependence or addiction.

Drugmakers are also a potential obstacle in the way of an OTC switch. Matt Ruth, a spokesperson for Adapt Pharma, which distributes Narcan (the only FDA-approved nasal spray of naloxone), says that certain factors would need to change before an OTC designation would make sense for his company, including more consumer demand and users who are better educated about the drug. The company also echoes the view that doctors should be involved in its use. “You want the physician to have a discussion with the patient, educating them on opioids and the inherent risks,” Ruth says.

The FDA could theoretically initiate the Rx-to-OTC transition without a drugmaker’s permission—through a process called public rule-making—but a forced switch has never been successfully invoked by the agency. For the moment, more moderate steps are in motion. Sarah Peddicord, an FDA spokesperson, says the agency has developed a model drug-facts label for naloxone—explaining proper diagnosis, usage and warnings. The FDA is also conducting tests to see how well consumers understand the guidelines, and to see if they can safely administer naloxone without a physician or pharmacist. This review, scheduled for completion next year, is a nudge to drugmakers, decreasing the time and expense they would otherwise have to spend on such studies.

The FDA has held similar hearings to encourage other OTC switches in the past, says David Spangler, senior vice president of the Consumer Healthcare Products Association, a trade group representing OTC manufacturers. But such switches occur only in the face of grave public health problems, such as avian or swine flu epidemics. The FDA’s action in taking these “extremely rare” steps signals that the agency believes naloxone has an important role to play in a public health crisis of the highest order.