Amid Overdose Epidemic, Public Health Advocates Urge FDA to Make Opioid Overdose-Reversing Drug More Available
On Friday, the Food and Drug Administration held a groundbreaking and powerful full-day hearing on making the generic, prescription-only opioid overdose antidote naloxone more widely available. In partnership with the FDA, the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Center for Disease Control (CDC) held the hearing to consider making the overdose-reversing drug more widely available -- outside of conventional medical settings -- to reduce the growing number of overdose fatalities from drugs such as OxyContin, Percocet and heroin.
Over two dozen public health, harm reduction and parent advocates, along with physicians and other medical professionals flew in from around the country for this unprecedented opportunity to advocate for expanding access to the lifesaving drug. Virtually every major overdose expert in the country attended, and urged the FDA to move naloxone to over-the-counter status (OTC).
Many advocates were visibly stunned and heartened when Dr. Bertha Madras, former deputy director of the White House Office on National Drug Control Policy, explained that her previous statements about the need to keep access to naloxone limited had been misconstrued. While she doesn’t believe that it should be available without a prescription, “life comes first,” she said. She equated a near-fatal accidental overdose with attempted suicide, riling many in the room who know that not everyone who accidentally overdoses on a prescription pain killer is a suicidal drug addict, but agreed with others that naloxone does indeed prevent death and should be made more widely available.
Naloxone is currently available in two forms: via intramuscular injection and a nasal spray. Many officials at the meeting agreed the intranasal form is preferable, primarily due to ease of use, but argued that more research is needed. FDA officials went out of their way to explain to pharmaceutical companies, researchers and advocates what needs to be done to move forward with developing and marketing intranasal naloxone, through the regulatory process and to ultimately make nasal naloxone available OTC.
The officials expressed a sense of urgency, and in a few cases became visibly choked up, as they heard stories about lives saved and others lost. While emergency room physicians and paramedics have routinely administered naloxone to people experiencing opioid overdoses for decades, access to naloxone remains limited due to a number of regulatory and ideological hurdles.
Since receiving FDA approval in 1971, naloxone is believed to have saved tens of thousands of lives. According to a recent CDC Morbidity and Mortality Weekly Report, increased access to naloxone through a very small number of underfunded overdose prevention programs has already saved more than 10,000 lives. If a limited number of small, underfunded community-based naloxone distribution programs have already saved so many lives, and naloxone has such a long track record of safety and efficacy, why the delay in dramatically scaling up access to this lifesaving medicine? At a time when deaths due to accidental drug overdose have exceeded the number of fatalities from motor vehicle crashes and more than 28,000 die from an accidental overdose every year, why would there be any hesitation in scaling up availability of this affordable, generic drug? Two words: profit and stigma.
Due to its status as a generic drug, and with a total market value of approximately $22 million, the financial incentive for new manufacturers to tackle the long, expensive process of bringing naloxone to over-the-counter status is minimal. One official explained that the cost of the additional research required to bring it OTC would likely exceed the total dollar value of the market. Meanwhile, people continue to die from preventable overdose every day because the solutions are expensive and time-consuming. The cost involved, coupled with drug warriors' belief that making naloxone more widely available will encourage people to take more drugs in riskier ways, presents real challenges. While no research supports the supposition that naloxone encourages risky behavior, drug warriors continue to cling to preconceived ideas about the value of saving the lives of people who use drugs.
So what’s the solution? We have what has been called by many experts “a miracle drug,” which can cost as little as $40 per lifesaving dose, that most physicians either don’t know about or won’t prescribe due to regulatory restrictions, with a 40-plus-year track record of safety and efficacy. It can’t be abused and you can’t get addicted to it. It brings people back from the brink of death. It is the only drug of its kind in the world. It works and everyone knows it. The only question that remains is, who is going to make the critical investment to bring this miracle drug to the masses?
The Drug Policy Alliance released a new policy brief titled "Expanding Access to Naloxone: Reducing Fatal Overdose, Saving Lives," to coincide with the FDA hearing. The brief details how naloxone is already saving lives, and includes steps that policymakers and public health officials can take to further reduce fatal overdoses.