What Dr. Makary Said About the FDA That Left Fox News Host Stunned

Posted: Oct 04, 2021 9:30 AM
What Dr. Makary Said About the FDA That Left Fox News Host Stunned

Source: AP Photo/Andrew Harnik, File

Merck & Co’s stock price rose sharply on Friday after the drug company announced positive clinical trial results from its experimental anti-viral Covid-19 pill. Data showed the pill halved the chances of dying or being hospitalized for at-risk populations—a breakthrough advancement in the fight against the global pandemic. 

Discussing the development on Fox News Monday morning, Dr. Marty Makary, a professor of surgery and health policy at the Johns Hopkins University School of Medicine, called it the “most profound scientific achievement since the vaccines.” 

“A 50 percent reduction in the death rate, an oral pill with a simple 5-day course. It’s safe, it works against all variants, it can be used in combination with other therapies,” he said. “The [Food and Drug Administration] needs to enact an expanded access protocol to liberate this medication. We've got 1.7 million on the shelf, we need to give it to people sick with Covid today under this protocol while they consider if for an emergency use authorization.”

Host Brian Kilmeade and Makary then discussed how the FDA has done this in the past with convalescent plasma and Regeneron.  

Kilmeade wondered why, then, Merck isn’t going “to bat for their own drug.”

“Well, they’ve got to be very careful with the FDA," Makary responded. "If you do something out of line with what they want you could offend them and the FDA is vindictive and they will hold up authorizations and approvals.”

The Fox News host couldn’t believe what he just heard.  

"Are you kidding? The FDA is vindictive?” he asked.

"First of all this is the most political FDA in U.S. history," Makary claimed. "Second of all, the FDA has a long history of pulling products from companies that are unrelated to mistakes in other medication and device applications so companies have to be very careful, and that’s why you generally don’t see pharma complaining about the bureaucracy and red tape at the FDA—"

“They’re afraid,” Kilmeade interjected.

“Yeah, they’re afraid of the backlash,” Makary confirmed. 

“Yeah, that’s healthy,” the host responded sarcastically. 

Based on the Covid pill's clinical findings, "Merck plans to submit an application for Emergency Use Authorization (EUA) to the U.S. FDA as soon as possible," the company said Friday.

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