The proposal is supported by pharmaceutical manufacturers, who argue that the policy would allow them to provide doctors and hospitals with the latest research.
The information drug companies may present to customers must arise from sound research published in peer-reviewed journals. 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, and because many of them are funded by the industry, 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 M. 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.
The proposal seems bound to increase drug sales because it is explicitly geared toward lessening the FDA warnings, rather than heightening them. The proposal allows the dissemination of new information that "refines" the warning as long as it “does not indicate greater seriousness of the risk.” In other words, it does not cover the case when a drug may be more dangerous than the FDA-approved label suggests.
While the proposal calls for the new information to come from peer-reviewed academic journals, critics note that such research often suffers from industry bias.
The academic journals who publish the results of industry-funded studies try to weed out error, but they are not always successful.
Consider, for example, the case of testosterone drugs. Last week, the FDA required manufacturers of testosterone drugs to add information to the labeling about a possible increased risk of heart attacks and strokes.
Should a pharmaceutical firm want to "prove" that the FDA warning on testosterone is unnecessary, a company could fund its own study. The research on the safety on testosterone appears to be vulnerable to significant bias. A recent review of 27 testosterone safety trials showed that based on the 13 trials that were funded by the industry, testosterone drugs are relatively safe; over the 14 studies that were not paid for by pharmaceutical firms the risks of heart attacks and other troubles are doubled.
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.
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. The proposal follows others at the FDA that would give the drug companies greater latitude in recommending a drug to treat illnesses beyond what the FDA has approved.
Officials at PhRMA, the chief pharmaceutical lobbying group, rejected the idea that the proposal undermines FDA warnings. Instead, they said, the studies would "supplement" the information available to customers.
In a letter to the FDA, 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.”
“The Constitution‘s protection of an open and robust exchange of ideas—principles that are central to the meaning and purpose of the First Amendment—limits FDA‘s ability to regulate scientific communication,” according to the letter signed by PhRMA vice president Jeffrey K Francer. “PhRMA respectfully submits that FDA should give additional consideration to these First Amendment limitations in issuing final guidance.”
Francer was formerly an associate chief counsel at the FDA, according to PhRMA's Web site.
Robert Lawrence, a professor at Johns Hopkins schools of medicine and public health said the guidance suggests the FDA is "moving in the wrong direction" - that the agency should be seeking to provide more vigilance after the FDA approves a drug and more people encounter it.
“This would gut the whole regulatory process for drug safety,” Lawrence said. “FDA has expert committees that meet and review the data. We’re at risk of tossing that all out the window.”