None of that prevented Gingrich and Co. from trying to destroy FDA (and Kessler) altogether a few years later.

In the meantime, there were also a number of unforeseen consequences. And David K. is a lot less sanguine about the impact of PDUFA now than he was at the time.

I’ve learned a lot, and, for that, I give a lot of the credit to you and Ed and all the good folks here at Pharmalot. Thank you.

http://oversight.house.gov/documents/20070501193354.pdf

He is certainly not as enthusiastic about it as he once was, particularly because of the ways it has drained away CDER resources from other needs, as discuseed above.

Regardless of who is responsible for the current system, it is ripe for corruption.

The following comments are from David Kessler:

“Even if FDA’s funding were doubled or tripled, its resources and ability to detect emerging risks on the thousands of marketed drugs and devices would still be dwarfed by those of the drug and device companies who manufacture those products…

For that reason, the tort system has historically provided a critical incentive to drug and device companies to disclose important information to physicians, patients, and the FDA about newly emerging risks…

My greatest concern with preemption is that it would, I believe, dramatically reduce the incentives for manufacturers to act quickly and responsibly to detect, analyze, investigate, and take action on potentially serious and life threatening adverse reactions once a drug is on the market.” – David Kessler, Former FDA Commissioner, Oversight Committee Meeting, May 14, 2008”

PDUFA has a complicated history that involved a good deal of input from industry, FDA, and others at the time. So while Congress approved it, it seemes too simple to me to say they “set up” the PDUFA system.

The jury is still out on the full range of its impacts. As above, it certainly had the result of taking other CDER internal budgetary resources and moving them to new drug review.

As Jack2 points out, the FDA is a regulator. It regulates based on the laws passed by Congress and signed by the President. Congress set up the user fee structure, not the FDA. Congress decided that rather than fund the FDA to the extent that is required to operate effectively, a better alternative was to extract user fees from the industry. This is common practice at the federal, state and municipal level. If you don’t like it, go to your congressman and ask him/her to fully fund the FDA and ban user fees. In the end, it is not the user fee that impacts the positions taken by the FDA, but the leadership put in place by the administration.

Atlex

The FDA is attempting to make the law, enforce the law, and adjudicate the law, all on the side of Pharma–using fees paid to them by Pharma.

I’m not saying the FDA doesn’t need more money; I am saying, they shouldn’t be paid by the industry they police.

Actions talk. The FDA has shown that they are going to act on the side of big business.

What has PDUFA contributed to that? I’m not sure. In the past, way before PDUFA, industry presumed virtual free reign under some FDA regimes. Ask Frances Kelsey (who was ultimately supported by her own senior managers).

My own sense is that inappropriate “coziness” has more to do with who is in FDA senior positions than with PDUFA per se.