FDA proposal would allow drugmakers to rebut warnings

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 drug’s 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 differ widely in their results, a drug company could easily mislead customers — and possibly endanger patients — by presenting only a selection of new research.

The proposal “seriously undermines FDA authority,” Sidney Wolfe, founder of Public Citizen’s Health Research Group wrote Wednesday to 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 drugmaker 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 drugmakers can tell customers about their products has been the subject of regulation and sometimes — 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, critics said. 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 a letter to the FDA, the chief pharmaceutical lobbying group, PhRMA said while FDA has an “important role in evaluating the safety and efficacy of new medicines … we also must recognize the critical need for healthcare professionals to receive the most current, accurate and comprehensive scientific information.”

Read more here: http://union-bulletin.com/news/2015/mar/14/fda-proposal-would-allow-drugmakers-rebut-warnings/

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K J McNulty
K J McNulty
5 years ago

I am a Pharm D who used to work for a big pharma company. They must not make these changes!!! It will put patients at risk. Most of the representatives do not have a medical background. The current limits are pushed all of the time. If these changes happen, patients will have no idea whether or not they are at risk. They will become guinea pigs.

MaryBeth
5 years ago

I agree with KJ. FDA has a set of standards to test all drugs and their side effects. If individual companies start testing and contradicting the results, where are the standards. Patients won’t be getting reliable data and could suffer. Big Pharma should have scientist work in conjunction with FDA while the tests are being done and not try to confuse patients by contradicting them afterwards.

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