The Biden administration and its allies said Friday they want to make overdose-reversing drugs a ubiquitous part of American life, highlighting a plan to make naloxone available over the counter as House Republicans pressure the White House to stop fentanyl and address the overdose crisis.
Food and Drug Commissioner Robert Califf, speaking at the Whitman-Walker Health clinic in Washington, said he is pressing drugmakers to produce plans for making naloxone, which can revive a person suffering from opioid overdoses, available without a prescription.
The FDA says up to 4 milligrams of a naloxone nasal spray and up to 2 milligrams of an injectable form might be safe and effective for nonprescription use.
Dr. Califf said Friday that regulatory approval will hinge on whether manufacturers can demonstrate that users can take the drug properly — without outside help — and “the good that can be done can exceed the harm.”
More than 107,000 Americans died from drug overdoses in 2021. It was the highest death toll ever recorded and reignited questions about social isolation from the pandemic and efforts to thwart deadly fentanyl from pouring over the borders.
Fentanyl, which is often trafficked from China and Mexico, is viewed as a kind of Russian roulette. Users often overdose on the highly potent synthetic opioid without realizing it has been mixed into other drugs.
Dr. Rahul Gupta, director of the White House Office of National Drug Control Policy, said expanding naloxone is a key priority for Mr. Biden, who wants to make it a widely accepted tool like defibrillators, which reverse cardiac arrest, or smoke alarms that are in nearly every home and business.
“We have so many people, including young people, unknowingly ingesting drugs that they do not know have fentanyl in them and dying at just an unacceptable rate,” Dr. Gupta said. “There is today, no excuse — no excuse, absolutely — for not having [naloxone] everywhere.”
Dr. Gupta said the country loses someone to an overdose roughly every five minutes — largely due to opioids, though methamphetamines are a big problem, too.
“This is largely preventable,” he said.
Sen. Tammy Baldwin, Wisconsin Democrat, endorsed the over-the-counter push, pointing to a fire extinguisher in the corner of the Whitman-Walker Health clinic.
“They save lives. Naloxone saves lives also,” she said.
Health and Human Services Secretary Xavier Becerra and his top lieutenants ticked through a list of efforts they’ve made over the past year to help people kick drug addiction and thrive. Their overdose prevention strategy included harm-reduction strategies that let people use drugs in less dangerous conditions; funding for programs that thwart prescription-drug abuse; an expansion of the number of people who can prescribe and treat opioid use disorder with buprenorphine; and the establishment of an “office of recovery.”
“A year ago we decided to go in a different direction at the federal level. We decided that we’re not moving fast enough,” Mr. Becerra said.
Efforts to fight overdoses and expand access to naloxone have offered a rare slice of bipartisan cooperation in recent years.
Yet Mr. Biden is under pressure to move more aggressively in combatting fentanyl. Republicans say lax border policies are fueling the problem because cartels and traffickers are bringing the drug into the country.
House Minority Leader Kevin McCarthy said last Thursday that tackling the synthetic opioid is on the GOP’s to-do list when it retakes the House majority in the new year.
“The economy, making us energy independent, I think securing our borders, stopping fentanyl,” Mr. McCarthy told reporters at a state dinner with France at the White House. “Holding government accountable. They haven’t had much of that. And I think the country, this last election was a check and balance.”