The United States is in the midst of a public health crisis. More than 59,000 people are believed to have died from drug overdose in 2016, an increase of nearly 20 percent from the previous year. Most of these deaths are caused by opioids like prescription painkillers, heroin and the potent synthetic drug fentanyl.
The Trump administration has said that addressing the opioid epidemic is a top priority. On Aug. 10, President Trump declared opioid use and overdose a national emergency. If the White House is serious about this problem, there is a simple step it should take as soon as possible to save thousands of lives.
A vast majority of opioid deaths are preventable if the person overdosing is given naloxone, a safe, easy-to-use and relatively inexpensive drug that has successfully reversed tens of thousands of overdoses over the years. But this medicine is often not on hand when and where it is needed. Making it more readily available could save many lives.
On Aug. 8, Tom Price, the secretary of health and human services, highlighted the importance of naloxone, saying it should be “as present as needed and possible anywhere across the country.” A week earlier, the Trump administration’s newly convened Commission on Combating Drug Addiction and the Opioid Crisis released an interim report endorsing increased access to the lifesaving drug. It made several recommendations that would increase its availability, including developing model legislation to require that naloxone be prescribed in combination with high-risk opioids.
But the commission failed to endorse one step that could be a game changer in what it calls a “national emergency”: making naloxone available over the counter.
Naloxone, approved by the Food and Drug Administration in 1971, has been designated an “essential medicine” by the World Health Organization and has been used for decades in emergency rooms, ambulances and clinics. It is not a controlled substance, it is not believed to have any potential for abuse, and it has no clinical effect if given to someone not on opioids. With minimal training, anyone can easily administer it.
But because it requires a prescription, naloxone is often not immediately available at the scene of an overdose. Every state has passed legislation to make naloxone easier to get, but the involvement of at least one medical professional is still required because only the F.D.A. can make the drug available without a prescription. This federal prescription requirement is a major barrier to access: Many people who are at risk of overdose lack health insurance or fear the stigma and judgment they may experience when asking a doctor for a naloxone prescription.
Although the F.D.A. has held several meetings on changing naloxone’s prescription status over the past five years, the agency has not taken any substantive action to make the drug available over the counter. That needs to change.
In general, to be approved for over-the-counter use, a drug must meet a few conditions: 1) The benefits outweigh the risks; 2) the potential for abuse and misuse is low; 3) the consumer can tell when the medication is needed; 4) it can be adequately labeled; and 5) health professionals are not necessary for its safe and effective use.
Naloxone meets all of these criteria. Two formulations — a nasal spray and an auto-injector — were specifically designed to be used by laypeople, and people with minimal training have already used them to save many thousands.
Under F.D.A. regulations, a petition to move a prescription medication to over-the-counter status can come from a manufacturer, the F.D.A. commissioner or “any interested person.” The F.D.A. has taken minimal action so far, creating a draft label for over-the-counter use in the hope that a drug company will ask for approval to market naloxone over the counter.
This has not happened, and amid a public health crisis, the F.D.A. should take action on its own. The administration’s commissioner should immediately undertake an expedited review of the evidence and exempt one or more formulations of naloxone from the prescription requirement. If additional information is needed, the F.D.A. should expeditiously gather it. If the agency fails to act, Congress can and should require it to make that determination within a short time frame.
Mr. Trump has repeatedly vowed to end the opioid epidemic. Making naloxone available over the counter would be an important and easy step that the administration could take quickly to save lives. The F.D.A. can help the president achieve this goal — one widely shared by Americans of all political persuasions — by making naloxone easier to get.
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Megan McLemore is a senior health researcher at Human Rights Watch. Corey Davis is a senior attorney at the National Health Law Program.
