Industry Distortion of the F.D.A.

NY Times ^ | Dec 8, 2004

[Tumbleweed_Connection]

Twelve years ago, the White House and Congress made an agreement with the pharmaceutical industry that seemed eminently reasonable at the time. The industry would supply substantial sums - reaching $200 million a year at latest count - to help the Food and Drug Administration hire more reviewers to speed the approval process for new drugs that might otherwise be held up solely by administrative logjams. The quid pro quo was that the government had to meet tight deadlines for reviewing drugs and had to keep steady its own financing for new-drug reviews, adjusted for inflation.

That seemed a reasonable way to ensure that the government did not cut back on its own funds and use the industry money to pay for reviewers already on the staff. But as an article by Gardiner Harris in The Times on Monday made clear, this 1992 deal - negotiated under the first President George Bush and updated under President Bill Clinton and again under the current president - has grievously distorted the agency's drug safety programs in unforeseen ways.

The blame lies with successive administrations and Congresses that failed to keep sufficient funds flowing to the F.D.A. for pharmaceutical programs. As a result, the agency has had to cannibalize programs to monitor the safety of drugs after they are on the market to keep up its reviews of new drugs before they are allowed on the market. The shift in emphasis is striking. In 1993, the agency's Center for Drug Evaluation and Research spent 53 percent of its budget on new-drug reviews, with most of the rest used for programs to ensure that drugs already on the market were safe. By last year, 79 percent of the agency's budget went for new-drug reviews.

Almost everything else has been starved. Half of the scientists in the drug center's labs are gone, reducing the agency's ability to conduct independent testing of suspect drugs. Collaborations with respected academic groups that assess drug side effects have ended. Both were savaged so money could be diverted to maintain a computerized listing of side-effect reports. This is the agency's main tool to detect postmarketing problems, and virtually all experts say it has serious shortcomings.

We are not optimistic that a Republican-dominated Congress and administration, beholden to drug industry campaign contributions, will leap to change a system that works to the industry's advantage. But the last three presidents and their Congresses got the F.D.A. into this bipartisan mess, so Washington ought to fix it. One solution would be to revisit the agreement so corporate money could be used to support a wide range of postmarketing checks, not just initial drug reviews. An even better approach would be to increase federal support for the F.D.A. so safety monitoring would be adequately financed and the industry's influence would be proportionately reduced. That should not prove frightfully expensive and would be a price worth paying.

[FreeKeys]

The problem is the same as with all governmental regulatory agencies. It's called "capture." The agency becomes a captive of whoever in the private sector cares the most about it, invariably those who are regulated (duh). That's why having a private regulator like the ultra-successful, untouchable, unbribable, politics-free Underwriters' Laboratories would be vastly preferable.

Check out: http://freedomkeys.com/complex.htm

[cosine]

In this case the problem is that the drug regulators get pilloried whenever someone dies from a drug ruled safe (no drugs, not even aspirin are safe so the fact that the FDA pushes this malarky is just another example of how messed up the regulatory structure is). If regulators rule a drug unsafe nothing happens except that thousands of people continue to suffer and die without making headlines.

Estimates suggest that the delay in approving beta blockers here for 10 years after they were widely used in Europe cost something on the order of 100,000 lives.

Result? A process biased towards long and drawn out regulatory procedure. A faster way would be to let firms market drugs but give regulators ability to withdraw them from market within a year or two if problems cropped up that weren't disclosed or expected.

[HiTech RedNeck]

Or, keep on marketing them but with suitable warnings; any refill prescriptions would have to be reissued by a doctor.