[Vendome]

Fuller quote: "How did we ever get to the point where private industry is providing so much support for a federal agency? Actually, 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. Patients, advocacy groups, pharmaceutical companies, and physicians were all concerned that important new medicines were being denied to Americans."

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.

[Vendome]

[Steve_Seattle]

" . . . 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 crazy. Why aren't they budgeted in the normal way, through tax dollars? Why allow such an obvious potential for conflict of interest?

[ifinnegan]

Propublica.

Leftist/commie as the day is long.

[Brian Griffin]

The problem is the product testing is done under drug company contract.

[packagingguy]

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.

[entropy12]

Corporations provide 75% of campaign cash on average for all political candidates and institutions. Where is the news in this?

[mewzilla]

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!

[Machavelli]

Duh! big pharma pays everyone off