Last Call For The FDA Goes Viral, Con't

The last shred of independent, objective authority in the Food and Drug Administration has been lit on fire in Health and Human Services Secretary Alex Azar's office trashcan, as the agency is now fully and totally under control of Azar and by default, under control of Donald Trump.

In a stunning declaration of authority, Alex M. Azar II, the secretary of health and human services, this week barred the nation’s health agencies, including the Food and Drug Administration, from signing any new rules regarding the nation’s foods, medicines, medical devices and other products, including vaccines.

Going forward, Mr. Azar wrote in a Sept. 15 memorandum obtained by The New York Times, such power “is reserved to the Secretary.” The bulletin was sent to heads of operating and staff divisions within H.H.S.

It’s unclear if or how the memo would change the vetting and approval process for coronavirus vaccines, three of which are in advanced clinical trials in the United States. Political appointees, under pressure from the president, have taken a string of stepsover the past few months to interfere with the standard scientific and regulatory processes at the health agencies. For example, a much criticized guideline on testing for the coronavirus was not written by C.D.C. scientists, and was posted on the agency’s public website over their objections. It was reversed on Friday.

Outside observers were alarmed by the new memo and worried that it could contribute to a public perception of political meddling in science-based regulatory decisions. Dr. Mark McClellan, who formerly headed the F.D.A. and now runs Duke University’s health policy center, praised the agency’s work on vaccine development but said the policy change was ill-timed.

“We’re in the midst of a pandemic, when trust in the public health agency is needed more than ever,” he said. “So, I’m not sure what is to be gained with a management change with respect to F.D.A. when they are doing such critical work.”

Dr. Peter Lurie, president of the Center for Science in the Public Interest and a former associate commissioner of the F.D.A., called the new policy “a power grab.”

Many rules issued by federal health agencies are signed by lawyers or by the heads of agencies, including the F.D.A., under the umbrella of H.H.S. The new memo requires the secretary to sign them, which Dr. Lurie said could lead to delays in the regulatory process.

“It will introduce an element of inefficiency within government operations that is wholly unnecessary and likely to gum things up,” he said.

Brian Harrison, chief of staff for Mr. Azar, described the new policy as “a housekeeping matter,” aimed at no agency in particular. He said it would have no bearing on how the agency dealt with coronavirus vaccines.

“This was simply pushing a reset button,” Mr. Harrison said. “This is good governance and should have no operational impact.”

The funny part is Brian Harrison is right: this won't have an "operational impact" on the FDA approval process for a COVID-19 or other vaccines going forward because the process was always going to be Azar approving a vaccine to help Trump politically no matter what FDA testing and protocols say.

 I practically guarantee you there will be a vaccine "approved" and distributed to medical personnel before the election. There's going to be a big fight about this and whether or not anyone takes the vaccine, but it will absolutely be announced in late October and will be made available "soon" for widespread use.

That "soon" part will be a lot trickier should Trump win, but the point is Azar and Trump believe it will win him the election. Actually having the vaccine work, well, that will come later.