Thatβs nothing at all and is a normal part of the IND application process. The FDA collects fees from the companies to comp for the massive amount of man-hours that go into reviewing their data, inspections, audits, etc. Iβm not saying itβs not abused, but thatβs the reason given. Even small companies get assessed applying for IND approval.
This is how the system has worked since, IIRC, 1992.
Prior to that, the FDA had been fully taxpayer funded. It was grossly underfunded and it could take years to evaluate a New Drug Application (NDA). It was horribly inefficient and the result was a lot of frustration that promising new drugs that could save lives were trapped in miles of red tape and bureaucracy.
So, we got a conservative solution. We asked the people who used the government service to fund it. If you wanted this government service, you had to pay for it, not different than paying a fee to enter a Nation Park which funds its upkeep. What emerged was the Prescription Drug User Fee Act, which is now regularly and unceremonious renewed every 5 years because it works.
So, if you file for FDA approval of a new drug in the US, you pay a fee which covers the cost of reading through all of that research, evaluating it, and making a determination whether that drug is safe and effective to be sold in the US as a prescription drug. All pharma companies pay such fees. It's not a bribe. It's literally just paying the government to employ competent scientists to evaluate a literal mountain of evidence, often thousands of pages, and make a recommendation to approve or not approve a drug.
Billions of dollars get spent just getting a product ready for market in the United States. Hundreds of millions of that are spent on licenses and applications for govt patents, etc.
While it is still ridiculous, it is pretty standard stuff, tbh.
Thatβs nothing at all and is a normal part of the IND application process. The FDA collects fees from the companies to comp for the massive amount of man-hours that go into reviewing their data, inspections, audits, etc. Iβm not saying itβs not abused, but thatβs the reason given. Even small companies get assessed applying for IND approval.
https://www.fda.gov/industry/prescription-drug-user-fee-amendments/standard-costs-thousands-dollars-components-process-review-human-drug-applications
Is that the price to get to front of line?
Funny part is, it's still not approved:
Go here: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine
Scroll down to "For Healthcare Providers" Ages 12+ Page 13, first bulletin
There really is nothing to see here.
This is how the system has worked since, IIRC, 1992.
Prior to that, the FDA had been fully taxpayer funded. It was grossly underfunded and it could take years to evaluate a New Drug Application (NDA). It was horribly inefficient and the result was a lot of frustration that promising new drugs that could save lives were trapped in miles of red tape and bureaucracy.
So, we got a conservative solution. We asked the people who used the government service to fund it. If you wanted this government service, you had to pay for it, not different than paying a fee to enter a Nation Park which funds its upkeep. What emerged was the Prescription Drug User Fee Act, which is now regularly and unceremonious renewed every 5 years because it works.
So, if you file for FDA approval of a new drug in the US, you pay a fee which covers the cost of reading through all of that research, evaluating it, and making a determination whether that drug is safe and effective to be sold in the US as a prescription drug. All pharma companies pay such fees. It's not a bribe. It's literally just paying the government to employ competent scientists to evaluate a literal mountain of evidence, often thousands of pages, and make a recommendation to approve or not approve a drug.
I get paying fees for assesment, though this can easily be abused if all those books are not open to public scrutiny with every dime accounted for.
Billions of dollars get spent just getting a product ready for market in the United States. Hundreds of millions of that are spent on licenses and applications for govt patents, etc.
While it is still ridiculous, it is pretty standard stuff, tbh.
F*ck oil-sponsored medicine.
What was the percentage for The Big Guy?