Merck Antiviral Drug Moves Closer to Approval

JEFFREY A. SINGER, CATO INSTITUTE

A Food and Drug Administration Advisory Panel just approved, narrowly, the Merck antiviral drug Molnupiravir. This is just step one. We now have to wait for the FDA to decide on emergency use authorization.The U.K. approved Molnupiravir on November 4.

Merck applied to the FDA for approval on October 11. Vaccines are the best long‐​term defense against COVID-19, but antivirals are the best first‐​line defense, especially when new variants can develop that escape the immunity provided by vaccines. Rather than wait weeks for the vaccine to take effect, antivirals—like antibiotics—work immediately to kill the pathogen.

The FDA’s bureaucratic foot‐​dragging must stop, especially with politicians considering reinstating lockdowns and bans on elective procedures.

Pfizer submitted its antiviral, Paxlovid, to the FDA on November 20. Let’s hope the FDA is quicker on Paxlovid—especially since the clinical trials were so impressive that, for ethical reasons, Pfizer interrupted the trial and immediately sought emergency use authorization.


Used with permission. Cato Institute / CC BY-NC-SA 4.0


Jeffrey A. Singer is a general surgeon in private practice in metropolitan Phoenix, AZ. He is principal and founder of Valley Surgical Clinics, Ltd., the largest and oldest group private surgical practice in Arizona. He was integrally involved in the creation and passage of the Arizona Health Care Freedom Act, and serves as treasurer of the US Health Freedom Coalition, which promotes state constitutional protections of freedom of choice in health care decisions. He was a regular contributor to Arizona Medicine, the journal of the Arizona Medical Association from 1994-2016. He also serves as a member of the Advisory Board Council, as well as an adjunct instructor, at the Center for Political Thought and Leadership at Arizona State University. He writes and speaks extensively on regional and national public policy, with a specific focus on the areas of health care policy and the harmful effects of drug prohibition. He received his B.A. from Brooklyn College (CUNY) and his M.D. from New York Medical College. He is a Fellow of the American College of Surgeons.