Big Pharma through regulatory fees pays over 50% of FDA’s budget and the money is all ear marked to review drugs for approval. Money to monitor following GMP’s Is lacking and is root cause of the baby formula fiasco!
I wouldn't have approved most baby "formula"* in the first place, even if manufactured according to GMP, but that may be another thread. ICIA (now AstraZeneca) wanted me to contribute to their PAC to get this fee-based "review" enacted. Drug approvals took too long if congressional appropriations had to fund them, you know. Burnt up on-patent time (also extended). Oh for the days of reasonable drugs like propranolol! (ICI bought Atlas Powder, of which Stuart Pharmaceuticals was a subsidiary, because they coveted the profits on propranolol.)
* Those who really need formula are much better off making their own, even though the FDA advises against it. Decent recipes are available. Use goat milk in the interim.
Because they're bribed to. Pharmas pay cost of evaluating drug applications. That seems to mean approve* if the FDA want any more such grants.
* Though only of the application paperwork, not the drug itself, in the case of Comirnaty.
Big Pharma through regulatory fees pays over 50% of FDA’s budget and the money is all ear marked to review drugs for approval. Money to monitor following GMP’s Is lacking and is root cause of the baby formula fiasco!
I wouldn't have approved most baby "formula"* in the first place, even if manufactured according to GMP, but that may be another thread. ICIA (now AstraZeneca) wanted me to contribute to their PAC to get this fee-based "review" enacted. Drug approvals took too long if congressional appropriations had to fund them, you know. Burnt up on-patent time (also extended). Oh for the days of reasonable drugs like propranolol! (ICI bought Atlas Powder, of which Stuart Pharmaceuticals was a subsidiary, because they coveted the profits on propranolol.)
* Those who really need formula are much better off making their own, even though the FDA advises against it. Decent recipes are available. Use goat milk in the interim.
Great Substack. I wholeheartedly agree!