“The Prescription Drug User Fee Act (PDUFA) is due for reauthorization in 2022”, says the National Institute of Health. “Beyond creating the user fee program which now generates a majority of the FDA Human Drugs Program budget… The majority of policy changes enacted through PDUFA legislation have favored industry through decreasing regulatory standards, shortening approval times, and increasing industry involvement in FDA decision-making” (1).
“User fees and increasing pharmaceutical company involvement with the FDA?” Please tell me that this doesn’t mean that the pharmaceutical industry pays “user fees” that account for over 50% of the FDA’s Human Drug Program budget to become more involved in decision making? Is this not billions of dollars?
I’ve never been accused of being the sharpest tool in the shed, but that sounds like cheating to me. Paying money to the very people who decide whether your drugs is approved? How does this differ from handing your IRS investigator a bag full of cash to close the deal? Are governmental regulators and politicians OK with this set up? Are doctors comfortable prescribing new drugs based on this questionable relationship between the FDA and drug companies? Am I the only one who sees a blatant conflict of interest here?
The important thing is that you now know this and can strike up a conversation with your doctor should a new drug be advised. I wish everyone had a naturopathic doctor to consult as a backup to a physician’s therapeutic recommendations. Be wise and extremely careful!
1. National Library of Medicine: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8917050/
Just because it has FDA Approval…
Prescription Drugs – Can We Live Without Them?
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