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Monday, May 14th 2007

More Power To The FDA, No Drug Imports

I can think of two things wrong with that title this bill. This bill being S 1082, which was passed last week. It expands the FDA’s tools in dealing with pharma.

Under the bill, the government would establish a surveillance system to track the adverse effects of prescription drugs. Scientists would analyze data on tens of millions of patients, looking for signals that particular drugs pose serious risks.

Under current law, the government and drug companies sometimes haggle for months over changes in drug labeling, and the drug agency can request but not compel manufacturers to perform studies after a drug has been approved.

Under the Senate bill, the government could order changes in a label and require the manufacturer to conduct more studies and clinical trials of a drug already on the market.

The bill would also require the government to establish a public database of clinical trials and their results. Lawmakers said this would make it difficult for drug companies to hide evidence of safety problems, as, they said, some companies had done.

The bill also doubled the fines the FDA could lay on pharma.

Okay, after that description of the bill it is clear that the “overhaul” of the FDA’s power is less than dramatic. The bill was benign enough for nearly everyone to jump on board. So I suppose there’s not a lot of complaining to do, even for those who see problems in the restrictions on personal choice and innovation which the power of the FDA contributes to. Granted castrating the already questionable authority of the FDA wasn’t exactly a popular (and thus reasonable) position…not after Vioxx and such.

This was about as benign an “empowerment” of the FDA as could’ve been hoped for, seeing as it doesn’t dramatically alter their realm of authority or their relationship with private industry. As well, if the description in the NYT’s piece is to be believed, it even does some good things in protecting patient and physician choice,

Mr. Enzi said the bill could speed the approval of new drugs, by giving the agency more tools to protect patients after treatments had been approved. The agency would no longer have to rely on “the nuclear option, which is pulling a drug completely off the market,” an extreme step that may disrupt patients’ care, Mr. Enzi said.

The agency could instead require a manufacturer to adopt a “risk evaluation and mitigation strategy” for a drug that posed serious risks.

As part of a risk-management plan, the agency could require that any television or radio advertisements for a drug describe its risks “in a clear and conspicuous neutral manner,” with fines for false or misleading commercials.

Sure we I could’ve hoped for more, say as Senator Robertson (R-KS) laid out,

Kansas Republican Pat Roberts wants to strip the bill’s controls over direct-to-consumer drug advertising.

“If the bill were to pass in its current form, we would have a situation where the secretary — at his discretion — is mandating certain warning requirements for all advertisements,” Roberts said in a statement. He called such requirements a violation of the First Amendment and said that instead drug companies should pay fines for misleading ads.

But the bill isn’t exactly a dramatic expansion of government intrusion in to health care. And there are more disappointing things. Chief amongst them is the dumping done on an amendment to allow drug importation; as well as the bizarre expansion of incentives for drug companies to test drugs in pediatric populations. Returning money to drug companies, even money they paid as fees and costs to the FDA, to do something they should do just doesn’t make a whole lotta sense from here.

The so close, yet so far story of Senator Dorgan’s amendment to allow drug importation is particularly distressing. The amendment passed by voice vote (so there’s not a record of who did and did not vote for it, ick). But was gutted by another amendment.

That’s pretty slimy. The requirements of the new amendment, which it was clear would end the possibility of prescription drug importation, included,

Opponents of a Senate proposal to allow the importation of prescription drugs claimed a surprisingly wide victory Monday, adopting an amendment that foiled the intent of a provision by North Dakota Democrat Byron L. Dorgan.

The Senate adopted, 49-40, a second- degree amendment by Thad Cochran, R-Miss., that would require the Health and Human Services Department to certify the safety and cost savings of any drug imports.

The Bush administration has said it cannot do that, so the effect of Dorgan’s drug importation language, subsequently adopted by voice vote, was rendered moot.

Oh well. Maybe in the future.