Pandemic Timeline

Uncategorized

Senior FDA leaders stepping down

Tags:

Marion Gruber is the Signatory Authority listed on the Emergency Use Authorization.

Marion Gruber, director of the FDA’s Office of Vaccines Research & Review, and deputy director Phil Krause will exit the agency in October and November, respectively, according to a letter shared with CNBC by FDA spokeswoman Stephanie Caccomo.

A former senior FDA leader told Endpoints that they’re departing because they’re frustrated that CDC and their ACIP committee are involved in decisions that they think should be up to the FDA. The former FDAer also said he’s heard they’re upset with CBER director Peter Marks for not insisting that those decisions should be kept inside FDA. What finally did it for them was the White House getting ahead of FDA on booster shots.

Much of the discord within the agency centers on the administration’s decision to push ahead with boosters before FDA’s top scientists had a chance to weigh in.

Their announced plans to depart come as the Biden administration prepares to begin offering Covid vaccine booster shots to the general public the week of Sept. 20.

Meanwhile, Paul Offit, a member of FDA’s vaccine advisory committee, stated of the booster plan that it was “the administration’s booster plan; it wasn’t the FDA’s booster plan. The administration has kind of backed themselves up against the wall a little bit here.”

The booster decision … was made by and announced by the nation’s leading public health officials, including Dr. Walensky, Dr. Fauci, Surgeon General Vivek Murthy, Dr. Janet Woodcock —the acting FDA commissioner —Dr. Francis Collins, Dr. Kessler and others. And as our medical experts laid out, having reviewed all the available data, it is in their clinical judgment that it is time to prepare Americans for a booster shot.

“With 50% of its overall budget and 75% of its drug-testing budget coming from industry, the FDA long ago won its notoriety as the most corrupt and pliable of all federal agencies,” said Children’s Health Defense Chairman Robert F. Kennedy, Jr.

“Now, the White House has torn away its last shred of integrity by ordering top regulators to put politics before science.”

These FDA executives are upset because:

  • Biden said that boosters would be available September 20 without consulting them.
  • The CDC and its ACIP are making decisions that these executives believe belong to the FDA.
  • Their boss, Dr. Peter Marks, was not standing up to Biden and the CDC to protect the FDA’s authority.

There are indications that UK health officials are under pressure as well.  UK health officials are advising against jabs for children, but politicians are pressing forward anyway.

Both resigned FDA executive have since appeared as coauthors of an article in The Lancet.

Sources:

Related:

See also, on this site:

Comments are closed.