Senate Introduces FDA Reforms

Apparently what they think it needs to have is more power and responsibilities! Since when did the nanny-state become a bi-partisan agenda? Oh right, that's the "compassionate" part of the neo-con platform. Story from the WP:

"WASHINGTON - A bipartisan bill represents the best shot in years to improve the safety of drugs the Food and Drug Administration regulates, but needs bolstering to heal the ailing regulatory agency, witnesses told lawmakers Thursday.

The bill, introduced in August by Sens. Mike Enzi, R-Wyo., and Ted Kennedy, D-Mass., comes on the heels of a string of high-profile drug recalls and safety warnings. Among them was the 2004 withdrawal of the popular painkiller Vioxx after long-term use was linked to an increased risk of heart attack and stroke.

"Millions of Americans rely on the drugs that FDA approves. They take them for sickness. And now the FDA urgently needs treatment," Kennedy said.

Two panels of witnesses, including representatives from industry, consumer and patient groups, praised the bill's timeliness, saying it would improve safety - and the public's confidence.

"The initiative now before you represents the best opportunity in many years to fix these chronic problems," said Dr. Steve Nissen, a Cleveland Clinic cardiologist who served on an FDA advisory panel that in 2001 recommended new warnings on Vioxx.

Some of the bill's provisions, including a temporary ban on consumer advertising of newly approved drugs, echo proposals made in a September report on drug safety commissioned by the FDA. The report found that the FDA cannot track the safety of new drugs, nor respond quickly to problems, for want of money, people and power.

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More likely, drug companies need to run more trials before releasing a drug and spend more money on R&D than advertising. Most of the failures stated in the paper (Vioxx) are the fault of the pharmaceutical industry. Merck knew about the issues with Vioxx before it ever got to market and pushed it through counting on the bumbling FDA to approve it (ps - the FDA knew too, and tried to cover it up).

Secondly, this reform is basically a fluffy cloud of whipped air. The FDA doesn't need little tweaks, it needs to be burned to the ground and replaced with something else. How about instead of letting a politically-controlled arm of the executive branch decide what drugs get approved we have some sort of body made up of medical authorities and pharmacologists that asses the risks and benefits of new drugs and make a scientifically sound decision and hold big pharma to task? Or would that just be too sane for this country to handle?

If its shiny, purple, new and has the potential to make billions the FDA slides it through like a fish oil suppository. If its a vaccine for an STD or a cheap OTC contraceptive it gets bound up like a dolphin in a tuna trap. The FDA's problems are the same problems as FEMA's: it's agenda is the agenda of whatever the current administration happens to be.

Politically-appointed bueurocrats are the ones pulling the switches, not the medical community -- thats the problem with the FDA. Increasing after-the-fact fines on drug companies does nothing to address the underlying, shall I say it, diseased state of our healthcare system?