WASHINGTON — Nearly every person who’s run the Food and Drug Administration in recent history agrees the agency should break free from its political supervisors — a rare consensus from commissioners who served under Republican and Democratic administrations alike.
In two papers published Monday, all seven of the FDA’s most recent commissioners wrote that the current setup — in which the agency is a mere subdivision of the Department of Health and Human Services — interferes with the ability of its scientists to protect the health of the public. They described a situation in which a tangled web of responsibilities, along with political overseers who aren’t necessarily motivated by science, all make it harder for the FDA to keep people safe.
It seems that making an agency that regulates an enormous proportion of the US economy less accountable to voters (via elected officials) is a terrible idea.
Already industry often times has to deal with moving targets: what FDA agrees to in the design stage and what the entire new team due to FDA turnover accepts is sometimes totally different.
You saved the really bad news for the very end of this piece. Big pharma’s influence on FDA–on full view as we learn the history of the opioid plague–is probably at least as toxic as intra-governmental interference. Probably worse.
–I suggest an entirely different approach; a separation of FDA’s drug regulatory functions from current efforts to innovate for Faster Cures; a reformation of the FDA to be a healthcare version of the SEC responsible for regulating against bad actors and maintaining its’ drug approval role.
However, I would also suggest the formation of a new agency, the National Healthcare Innovation Agency; FDA’s current mission is confounded; I would suggest a healthcare agency similar to the Department of Commerce dedicated to helping particularly startup or relatively new healthcare concerns to navigate through a thicket of federal regulation and also to find and foster opportunities for public/private partnership within various federal and even state agencies (e.g.-NCATS, DARPA, etc.). This is particularly vital for the fostering of new pharma, those firms focused upon neglected and orphan disease, a field which appears to be distinct from big Pharma.
The recommendation to free FDA from HHS to avoid political manipulation is naive. Look at the history of AHRQ and subsequent attempts to independence. Congress just decimates the budgets of annoying agencies. Somebody has to be in charge, and that person is appointed or “fired” to use Trumpinology.
No question that FDA has become too political; CDC is even worse. One way to cede some independence would be to put them on a 5-year appropriation cycle mid-term presidential elections so their budget always comes up across 2 terms.