Turmoil at FDA or just another day?

SUMMARY: Marion Gruber, director of the FDA’s Office of Vaccines Research & Review, and deputy director Phil Krause will exit the agency because the White House is getting ahead of the agency on COVID booster shots. I would argue, however, that the FDA is a bureaucratic mess with changes needed at all levels of leadership.

(PBS.org) Nuplazid, a drug for hallucinations and delusions associated with Parkinson’s disease, failed two clinical trials. In a third trial, under a revised standard for measuring its effect, it showed minimal benefit. Overall, more patients died or had serious side effects on Nuplazid than after receiving no treatment. Patients on Uloric, a gout drug, suffered more heart attacks, strokes, and heart failure in two out of three trials than their counterparts on standard or no medication. Nevertheless, the U.S. Food and Drug Administration approved both of these drugs — with a deadly aftermath.

The FDA is increasingly green-lighting expensive drugs despite dangerous or little-known side effects and inconclusive evidence that they curb or cure disease.

Now two leading staff members of the FDA have resigned because the White House is getting ahead of the agency on COVID booster shots.

According to Medpage Today, “In the last 3 months, we have seen that the FDA does not have the ability to revoke accelerated approvals, even when the drugs and their sponsors fail to meet the promises made. And to wash that down, the FDA has now approved another uncertain drug for people who have Alzheimer’s, against the wishes of a different advisory panel”. That is a serious problem for drugmakers and patients.

While some are pointing fingers at the White House, I would push back and ask, “what in hell is taking the FDA so long to both approve COVID vaccines and booster shots?”. I would also like to know “who is advising President Biden when to comes to booster shots?

In late April, the FDA’s Oncologic Drugs Advisory Committee reviewed six accelerated approvals — a provisional pathway — involving a group of cancer immunotherapies where clinical trials had failed to confirm that the drugs extended survival or improved quality of life. Yet, the advisory committee voted to keep the accelerated approvals intact in four of the six cases. (source: Medpage).

Trust is not given because you’re part of an agency..it’s earned. The FDA has to earn the trust of both HCPs and the public. Putting people in charge who understand the atmosphere of drug approvals is a great first step.