FDA must act to increase naloxone availability

Our nation is in the midst of an addiction crisis, punctuated by a relentless epidemic of overdose deaths due to opioids and other drugs. With more than 700,000 American lives lost to overdose since 1999—and opioids a factor in 400,000 of them—it is imperative and long past time to dramatically expand access to the safe, life-saving medicine naloxone. The Food and Drug Administration (FDA) will hear options for that next week and should follow up with swift action.

Opioid misuse and addiction have escalated every year for almost two decades, continuing to devastate individuals, families and communities throughout the country. According to the CDC, 68 percent of drug overdose deaths in 2017—47,600 deaths—involved opioids. That is 193 lives lost to overdose each day, or one person every seven minutes. And while deaths due to opioids like heroin, methadone, morphine, oxycodone and hydrocodone appear to have plateaued in 2017, they remained at record levels. Meanwhile—due to a booming illicit market—28,000, or 60 percent, of the opioid deaths involved synthetic opioids such as fentanyl, carfentanil and fentanyl analogues, which collectively increased 45 percent over 2016.

{mosads}Naloxone is a medication that can reverse the effects of an opioid overdose and prevent death. In fact, it is preventing thousands of deaths already. Not enough, however. Not nearly enough.

On Dec. 17 and 18, two FDA external advisory committees will meet jointly at the request of Commissioner Scott Gottlieb, M.D., to discuss ideas for expanding the availability of naloxone—a priority also highlighted by U.S. Surgeon General Jerome Adams, M.D., in a rare national advisory in April. The committees accepted public comments on the topic in recent weeks and will ultimately make recommendations for the FDA to consider.

In Minnesota—where our organizations, the Hazelden Betty Ford Foundation and Steve Rummler Hope Network, are headquartered—in 2017 over 2,000 non-fatal opioid overdoses were treated in emergency rooms alone. That’s 2,000 people who were given the gift of life and the opportunity to get additional help and one day join the millions of Americans who, like us, are living full lives in long-term recovery from addiction. 

Naloxone is not a controversial solution medically. It saves lives and has no significant side effects. And, it is already carried by many first responders, such as EMTs and police officers. The surgeon general has recommended that more individuals—including family, friends and those who are personally at risk for an opioid overdose—should keep the medication on hand. We agree.

The issues are cost and availability. 

Injectable naloxone kits are relatively inexpensive, but they are the least user-friendly option, for a variety of reasons. A naloxone nasal spray, while much easier to use, costs about $135, and the naloxone auto-injector, costs $4,500. A generic version of the auto-injector may be available in mid-2019, retailing at approximately $178. With the rampant increase in fentanyl and its analogues, it now takes an average of two to three naloxone doses to reverse the effects of an overdose. With lives on the line, we believe everyone confronted with an overdose emergency should have access to the simplest and easiest-to-use delivery system. Therefore, we urge the FDA to heed all committee recommendations that address the affordability of auto-injectors and nasal sprays.

One specific action we would like to see in light of our national overdose crisis is the creation of a streamlined regulatory and approval regime for fast-track production of a generic naloxone nasal spray to compete with the higher-priced brand name products currently on the market.

A helpful tandem action would be to reclassify naloxone as an over-the-counter drug, rather than one requiring a prescription; doing so would be increase access and availability, while pushing down prices.

We also urge the FDA to strongly consider the idea of naloxone “co-prescribing.” Anytime an opioid prescription is written, a naloxone prescription should be included. Misuse of an opioid prescription—because you have developed an addiction, forgotten that you took a previous dose, or accidentally mixed it with other medicines—can cause an overdose and, indeed, has caused thousands of deaths. Amid the current crisis, prescribing naloxone alongside all prescribed opioids is a prudent way to get more naloxone out into the world.

Finally, we recommend that the FDA review the expiration- and efficacy-date standards for naloxone. According to recent research, naloxone products remain effective far past existing expiration dates. If the FDA is able to extend naloxone’s official shelf life, that would help with both availability and consumers’ costs.

While there is no silver-bullet solution to the opioid crisis, expanding access to naloxone is an essential step. It will help us help those we serve—saving lives and providing more people with the opportunity for long-term recovery.

Alexia Reed Holtum is the executive director of the nonprofit Steve Rummler HOPE Network, which began providing and advocating for solutions to the opioid crisis in Minnesota and nationally shortly after Steve died from an overdose in 2011. Alexia was Steve Rummler’s fiancé. Marvin D. Seppala, M.D., is the chief medical officer of the Hazelden Betty Ford Foundation, a nonprofit addiction treatment leader that has 17 locations nationwide and collaborates with an expansive network throughout health care.