Wonkblog: How the First Amendment is undermining the FDAs power to regulate drugs
The Food and Drug Administration is proposing to allow pharmaceutical companies to contradict official safety warnings in sales presentations to customers.
While an FDA warning about a drugs dangers can scare off buyers, the new proposal would allow the companies to present customers with information that undermines official warnings as long as it comes from a peer-reviewed journal article.
The proposal is supported by pharmaceutical manufacturers, who argue that the policy would allow them to give doctors and hospitals the benefits of the latest research.
But the proposal is drawing an avalanche of criticism from public health advocates who argue that because individual studies can differwidelyin their results, a drug company could easily mislead customers - and possibly endanger patients - by presenting only a selection of new research.
Most such research is paid for by pharmaceutical companies and while the academic journals who publish their results seek to weed out error, they are not always successful.
The proposal seriously undermines FDA authority, Sidney M. Wolfe, founder of Public Citizens Health Research Group wrote Wednesdayto the agency. Its main supporters are drug companies and their associations, all of which would benefit from being allowed and encouraged to sell more drugs by making them seem safer than FDA has judged them to be.
Under the proposal, FDA would not object to the distribution of new risk information that rebuts, mitigates, or refines risk information in the approved labeling. The studies must be well-designed and at least as informative as the data sources that the FDA used in generating the official warning.
For example, under the proposal a drug-maker could present evidence that the severity or frequency of a side effect is less than what is suggested by the FDA-approved label. Or it could question whether the drug causes the side effect at all.
Exactly what drug-makers can tell customers about their products has been the subject of regulation and sometimes - such as when the side effect has led to heart attacks, cancer, or suicide - billion-dollar penalties. But the industry has pushed back in recent years, arguing that under First Amendment, the government cannot curtail their right to disseminate information.
The proposal seems bound to increase drug sales because it is explicitly geared toward undermining the FDA warnings, rather than enhancing them. The proposal allows the dissemination of information that rebuts or mitigates the risk identified by the FDA, or information that "refines" the risk as long as it does not indicate greater seriousness of the risk. In other words, the proposed guidance does not cover the case when a drug may be more dangerous than the FDA-approved label suggests.
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Wonkblog: How the First Amendment is undermining the FDAs power to regulate drugs