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Missing the forest for the trees

One of the biggest problems of the Food and Drug Administration (FDA) is the limited postmarketing surveillance of its approved medicines. It is widely believed that cases such as the Vioxx fiasco could have been avoided if the effects of drugs continued to be carefully monitored after they find their way to the market.

It is therefore good news that the US Senate is supporting a bill that would give the FDA power to require postmarketing studies, the publication of negative clinical trials to bolster transparency, and the authority to fine companies that don't comply with these requirements. Unfortunately, as highlighted by a recent New York Times editorial, the success of the proposed reforms depends on hefty fees imposed on drug manufacturers. Such dependence is problematic, as it might increase the influence of the pharmaceutical Industry over the decisions of the FDA.

There is, however, a more immediate problem: the bill may not be approved at all, as the White House is already threatening to veto it. The point of contention is a proposal to allow the importation of cheaper prescription drugs from Canada and other countries into the US. Critics of this idea argue that it is dangerous for the public to gain access to foreign drugs that may not meet the same safety standards of the FDA or may even be counterfeit.

Fair enough. In fact, officials have been making a similar point since the days of the Clinton administration, stating that they couldn't possibly guarantee the safety of an imported drug. Nevertheless, those in favor of lifting the ban on drug importation dismiss these arguments as mere stratagems of the pharma industry to protect their interests.

But ultimately the pressing question is: should the bill be put at risk of being vetoed for the sake of this evidently controversial issue? It doesn't look like the Senate is going to back down, and we are already painfully aware of how stubborness of the White House. What gives, then? Hopefully not the interests of the public.

Comments

It's very good that FDA takes another step to integrate pharmacy market of Canada.

I agree that the FDA needs power for postmarketing studies, and definitely needs to be more transparent. I also think that most Americans don't worry about Canadian drugs--Canada is a developed, industrialized country.

But it's hard to disagree with pundits who argue against importing drugs when you see things like China substituting antifreeze for glycerol in counterfeit medicine. These medicines are commonly had throughout the developing world. Will the benefits of this law outweigh a couple hundred deaths if something like the Panama incident happened in America??

Perhaps a compromise--maybe allowing only genuine Canadian, British, and French drugs--will allow this bill to be more palatable.

As a medical student actively involved in the American Medical Association, what can I and my classmates do to effect this change?

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