FDA Whistleblower
@FDAWhistleblow1
Ron Kavanagh, Clinical Pharmacologist, Ex-FDA Reviewer 10 yrs, 7 w Neuro/Psych Fired 4 reporting felonies 2 FBI & 4 1st Amendment speech & petitioning Congress
True stories: Tom Laughren the psych medical director was heard yelling at one of his reviewers. "OUR JOB IS TO APPROVE DRUGS!" In a meeting I attended with a company about a non-approval, the company rep said "We paid you for an approval!"
Less rubber stamping at FDA is a good thing. On the other hand, qualified approvals are worth celebrating (and this part really shouldn't have to be said). Something about the idea of a sad and lonely rubber stamper at FDA made giggle.
Showed my wife. She said it was AI. I don't care. I think it's cute.
.@RxRegA Technically under federal law a senior employee is anyone at GS-15 or above. That would make almost every MD a senior employee As well as a lot of other people including both the clinical pharmacology division directors and associate division directors.
or staffer(s), both described as Senior.
Sometimes it is.
whistleblowing isnt your life but it is to the people your protecting
Being forced to use new computer programs, where there's little to no training, no manuals, and that often don't work so that time is wasted is standard for the FDA. However, it doesn't matter to management they just want to hit deadlines, and IT is afraid to tell them. Plus,…
Maybe Elsa won't solve the 20% cut & add'l departures at FDA: "AI is supposed to save our time, but I guarantee you that I waste a lot of extra time just due to the heightened vigilance that I have to have" to check for fake or mispresented studies, a 2nd @US_FDA employee said.
Vice versa, I've seen FDA conspire with a drug company to use long term safety data to dismiss treatment emergent suicide that occurred in the first 2-3 weeks of treatment. Made me realize that what's been said about tricyclic antidepressants since the 1960s. That they induce…
The acceptance of scientism and denial of facts is why so many are harmed. Drs have neither the truth nor the time or critical thinking skills to filter even the most fundamental of flaws. You cannot use data from short term studies to comment on long term results!!!!!!
A new government report raises questions about the effectiveness of involuntary outpatient treatment. STAT explores the conflicting evaluations and what’s at stake for patients in mental health care.
George Tidmarsh named new CDER chief, per Bloomberg bloomberg.com/news/articles/…
There was also a bill on patent thickets that I didn't look at but that I assume could apply to drugs.
H.R. 4486: To direct the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to conduct a study, and submit to Congress a report, on the human health impacts of exposure to microplastics in food and water. govtrack.us/congress/bills…
H.R. 4525: To protect an individuals ability to access medicines approved by the Food and Drug Administration to protect a health care providers ability to provide such medicines, and information related to such medicines. Probably about mifepristone (RU-486, Plan-B)…
S. 2345: A bill to allow for expedited approval of generic prescription drugs and temporary importation of prescription drugs in the case of marginally competitive drug markets and drug shortages. govtrack.us/congress/bills…
S. 2353: A bill to direct the Secretary of HHS, acting through the FDA Commissioner , to conduct a study, and submit to Congress a report, on the human health impacts of exposure to microplastics in food and water. Took me a while to figure out why this might fall under FDA. I…
S. 2341: A bill to amend the Federal Food, Drug, and Cosmetic Act to impose requirements for substances generally recognized as safe, to require the Commissioner of Food and Drugs to reassess the safety of chemicals added to food, and for other purposes. govtrack.us/congress/bills…
H.R. 4435: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency with respect to cosmetic ingredients, and for other purposes. govtrack.us/congress/bills…
H.R. 4433: To amend the Federal Food, Drug, and Cosmetic Act to ban certain substances in cosmetic products, and for other purposes. govtrack.us/congress/bills…
H.R. 4434: To amend title VI of the Federal Food, Drug, and Cosmetic Act to ensure the supply chain transparency needed for companies to make safe cosmetics, and for other purposes. govtrack.us/congress/bills…