Posted on 08/24/2021 1:41:51 PM PDT by Vendome
Caroline Chen of ProPublica has written a provocative article challenging the objectivity of the FDA in its approval of new drugs. Entitled: “FDA Repays Industry by Rushing Risky Drugs to Market”, Chen contends that the agency is beholden to the biopharmaceutical industry which pays three quarters of the FDA’s budget used for the drug review process. This is an astounding number. Is any other federal agency supported to this extent by the industry it regulates? Given this level of support, one might assume that the FDA would bend over backwards to meet the needs of its financial backers.
"...this all began about 25 years ago, when the U.S. was facing a “drug lag”. Because of a lack of resources at the FDA, drugs were being approved at a much slower rate here than in Europe. More than half of all drugs approved in the U.S. had been approved in Europe more than a year earlier. "
To solve this problem, Congress enacted the Prescription Drug User Fee Act (PDUFA) of 1992–a mechanism whereby charges were levied on pharmaceutical companies for each new drug application (NDA) filed. The revenues, known as “user fees”, were used to hire 600 new drug reviewers and support staff. These new medical officers, chemists, pharmacologists, and other experts were tasked with clearing the backlog of NDAs awaiting approval. In fact, one of the biggest years of NDA approvals occurred in 1996 when the FDA approved 56 new products
(Excerpt) Read more at forbes.com ...
Demand created the problem and givernment trusted other men not to be self serving fiends...
More from the article: As a concession to agreeing to these “user fees”, the pharmaceutical industry was promised that the FDA would reduce review times of NDAs to 12 months for those that were considered “standard” applications and to 6 months for priority applications that involved significant advances over existing treatments. The PDUFA Act has since been repeatedly renewed with PDUFA VI passing last year. And, as would be expected, “user fees” have gone up over the years, from $208,000 per NDA in 1995 to a whopping $2,421,495 for fiscal year 2018. Keep in mind that the industry didn’t exactly have a choice in this matter. PDUFA was a decision by Congress to make the pharmaceutical industry pay for the work it was generating at the FDA–work being done to get new medicines to Americans. It wouldn’t be surprising to see Congress eventually transfer 100% of the costs of FDA reviews of NDAs to industry.
Propublica.
Leftist/commie as the day is long.
The problem is the product testing is done under drug company contract.
Government for sale.
Pay to play..... Rule #1
The public was clamoring for drug approvals that made more sense.
Drugs in Europe had long been approved years before they could be approved in the USA and US citizens seeing positive results wanted drugs approved here as well and on the same time line.
The givernment couldn’t approve them fast enough with their budget limitations so they hatched this crazy partnership scheme with the BioPharma Industrial Complex and this is what we got.
The drug companies are experts at lying and cheating and bribing politicians.
Otherwise they would be out of business.
Think of it as Big Pharma in action.
Should clinical trials be done with public financing?
When submitting a medical device, pharmaceutical, IVD, etc. to the FDA for review the company doing the submission has to pay the FDA for their time. It has been that way for years.
The FDA reviews the data submitted to it, they do not collect the data themselves. Typically if a clinical trial is required those trials are run independently, not under the control of the manufacturer. Again the manufacturer must pay for the clinical trial but does not generate the results.
For example if our department generates a new product it undergoes trials at separate locations, generally at least two institutions are involved. Our department does not interfere with the clinical trials in any way. Then an independent contractor assembles and submits all manufacturing and clinical data, paid for by our company.
Yes, the FDA gets user fees from manufacturers, but imagine if they did not. The taxpayer would foot the bill for private gain.
Corporations provide 75% of campaign cash on average for all political candidates and institutions. Where is the news in this?
Money’s not all Big Pharma provides, is it...
Guess who works at the FDA?
Former Big Pharmers.
Can you say “revolving door”, boys and girls?
I knew you could!
Money’s not all Big Pharma provides, is it...
Guess who works at the FDA?
Former Big Pharmers.
—
It is the very definition of corporatism or to be more vernacular fascism.
Yup.
We are in such deep doo doo.
Duh! big pharma pays everyone off
Follow the science!!
Follow the money!!
Lmao. Our country is utterly corrupt. I’ve come to accept it and honor no previous loyalty.
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