The federal agency stated its position at a press briefing on Wednesday held jointly with the drug czar’s office, the Centers for Disease Control and Prevention and the Drug Enforcement Administration (DEA) to announce the agencies’ strategies to fight prescription drug misuse and report on new analyses of data on the sources of misused prescription drugs. In the U.S., 15,000 people die of opioid overdose — from prescription drugs including Oxycontin and Vicodin — each year.
FDA Commissioner Dr. Margaret Hamburg noted at the press conference that “last week, the FDA convened an important public meeting on naloxone,” referring to the agency’s hearing on whether to make naloxone, a prescription drug, widely available to all over-the-counter. (I covered that hearing here.)
Naloxone (sold under the brand name Narcan) is a nontoxic, non-addictive drug that can reverse potentially fatal opioid overdose. The drug is currently available without a prescription only through certain channels: namely through small, community-based distribution programs that put the life-saving drug in the hands of people at high risk and their families. These programs have dispensed 50,000 doses of naloxone since 1996 and have reported 10,000 cases of overdose reversal.