Last summer, the FDA issued draft guidelines for changing what information drug company representatives must provide health-care professionals about the potential side effects associated with their product. Some of the revisions were 180 degrees different from what drug label warnings are required to contain now, and judging by public feedback, they’re not popular.
According to a recent story on AboutLawsuits.com, public comments to the FDA are almost unanimous in their opposition, and consumer watchdog Public Citizen reflected this wave of disagreement in a letter to Sylvia Burwell, secretary of the Department of Health and Human Services.
The FDA’s draft concerns new risk information, which it defines as “information that becomes available after a drug is marketed that rebuts or mitigates information about a risk already identified in the approved labeling or otherwise refines risk information in the approved labeling in a way that does not indicate greater seriousness or risk.”
For example, the feds could include drug data suggesting that the rate or risk level of a known side effect is lower than what was required for the label when the drug was approved for consumer use.
But how many times have drugs approved for marketing later proved to be much more dangerous than initially believed? To require label revisions or withdrawal from the market after people died or otherwise suffered serious harms? The diabetes drug Actos is an example of the former, when its risk of heart failure was discovered after it was released in 1999. The pain reliever Vioxx was yanked from the market in 2004, also after it was discovered to increase the risk of heart attack and stroke.
Because the FDA had published only one comment to the draft regulations by October, Public Citizen filed a Freedom of Information Act (FOI) request for access to more of what people were saying about the guidelines. By the time the letter was sent, the feds had posted about 80 comments.
According to the organization’s analysis of nearly 1,800 comments reviewed from the FOI request, 99% were opposed to the proposed guidelines for on distributing scientific and medical information on prescription drugs. Most of the comments indicated that the revisions would undermine the FDA’s authority and put patients at risk.
Public Citizen accused the FDA of hiding the clearly negative response – only 11 of 1,782 comments submitted by individuals, organizations or companies supported the draft guidelines. Ten of those were submitted by the pharmaceutical industry and one academic.
Opponents claimed that the revised regulations essentially would give drug sales representatives permission to lie to doctors regarding any serious health risks associated with their products, that providers could ignore them or that they don’t really exist. The relaxed requirements basically would permit Big Pharma to promote drugs “off-label,” which is illegal now.
Off-label use is when a doctor prescribes a drug to treat a condition for which it has not secured FDA approval. It’s not illegal for doctors to do so, but drug companies are prohibited from advertising them for those uses. They’re not allowed to promote drugs for any use until the FDA deems it safe and effective.
We regularly write about companies that routinely ignore this regulation (here and here), sometimes paying huge fines as a result. Of course, they continue to flout the rules because they make more money selling the drugs illegally than they pay in fines or settlements.
Dr. Sidney Wolfe, founder and senior advisor of Public Citizen’s Health Research Group, wrote the letter to Burwell. According a news release quoted by AboutLawsuits, he said, “As most of the comments stated, this proposed guidance is reckless and seriously undermines FDA authority. The FDA is supposed to be the government shield that protects patients when the industry pushes products that might not have a favorable benefit-to-risk ratio in order to line their own pockets. This guidance completely undermines that safety shield.”