July 9, 2020 3:27PM

FDA Should Help Defeat Another Viral Epidemic—HIV—By Reclassifying PrEP And PEP Over The Counter

Last October, California expanded the scope of practice of pharmacists to allow them to prescribe HIV pre‐​exposure prophylaxis (PrEP) and post‐​exposure prophylaxis (PEP) to people at risk. Similar legislation is currently being considered by the New York state legislature.

I have argued here that the Food and Drug Administration should reclassify PrEP and PEP as over the counter. While allowing pharmacists to prescribe PrEP and PEP is a step in the right direction, it would greatly improve access to the drugs for people at risk if they were available OTC. They can then be sold in retail and convenience stores in addition to drug stores. They might even be made available in vending machines, as is the case with emergency contraceptives, providing greater privacy along with convenience.

Research published this month by a team at the University of California San Francisco strengthens the argument for the FDA to move quickly on this. A randomized controlled trial of nearly 75,000 people in East Africa, an area of the world most affected by HIV, found PrEP resulted in a 74 percent reduction in new cases of HIV. The study found a 40 percent reduction in incidence among men and a 76 percent reduction among women. This latter discovery is particularly important, because clinical researchers have been uncertain as to the effectiveness of PrEP in women.

Medpage Today reported Catherine Koss, MD of the University of California San Francisco as saying:

“This shows in generalized epidemic settings, offering universal access to PrEP can reduce HIV incidence,” Koss said. “Moving forward, comprehensive HIV testing with linkage to treatment and prevention, including PrEP … [is a] promising approach to accelerated reductions in new infections.”

In response to the COVID-19 pandemic the FDA, in early March, relaxed many of its outdated and onerous regulations in order to fast‐​track the approval process for new tests and new drugs to combat the virus.

While the COVID-19 virus is on everyone’s mind, the HIV epidemic has been around for more than 40 years, with more than 36,000 people infected each year and 1.2 million Americans living with HIV.

The FDA should demonstrate the same commitment to the fight against HIV that it claims to have against COVID-19 by reclassifying PrEP and PEP OTC. ASAP.