This opinion piece by Sidney Wolfe, M.D., appeared in the Washington Post on September 10, 2003.
With gusto, Food and Drug Administration Commissioner Mark McClellan has promoted, in speeches and press releases, one of his priorities: increasing the amount of accurate information conveyed to consumers about FDA-regulated products. “I consider it a public health hazard when people are misled by false claims,” he said recently.
Unfortunately, this rhetoric obscures a pattern of FDA actions and inaction under his leadership that decrease the amount of accurate information in the marketplace and, in McClellan’s words, create “public health hazards.”
For example, in 1996 Congress instructed the FDA to give companies just five more years to start providing written prescription drug information leaflets for distribution to patients at pharmacies. If the companies failed to do so within that time – that is, provide leaflets that set out useful, scientifically accurate information – the FDA could take over the responsibility.
At a recent FDA meeting to evaluate the industry’s effort, a University of Wisconsin researcher commissioned by the FDA to do a nationwide study of the content of the patient information leaflets stated that the industry’s effort had, quite simply, “failed.” In a review of 1,367 patient information leaflets involving four different prescription drugs obtained at drugstores around the country, the study found that, given a possible score of 100 if all the important information was included, the average score of the leaflets was 53 – a failing grade.
Sections of the label with particularly poor performance included precautions, contraindications to using the drug and information about adverse reactions. Nevertheless, although the FDA has allowed these companies more than 25 years to get the leaflets right, the FDA signaled again last month that it will give the private sector yet another chance, rather than switch to government-approved patient leaflets of the kind used in Europe. As a result, millions of patients each year will continue to get dangerously inadequate information about the risks of their prescription medicines. Preventable injuries and deaths are sure to continue.
To take another example, misleading advertising aimed at doctors and patients can make the difference between someone’s getting the right drug and the wrong one. But with its practically moribund enforcement of the laws concerning prescription drug advertising, the FDA is again failing to protect against companies giving inaccurate information to consumers and doctors. From a peak in 1998 of 157 actions, the number of prescription drug enforcement actions – letters from the FDA’s Center for Drug Evaluation and Research to pharmaceutical companies ordering them to stop specific drug ads that understate risks or overstate benefits – fell to 27 last year. This year, under McClellan’s leadership, lax enforcement has continued. With only 14 such actions taken thus far, the agency is on pace to break last year’s record low. There is no evidence that the accuracy of drug ads has improved so much that FDA enforcement actions are not needed as frequently as in 1998.
Another step backward on accurate information involves something akin to the snake-oil promotions of years past. The Nutritional Labeling and Education Act of 1990 unequivocally states that any health claim for food must be backed up by evidence based on “significant scientific agreement.”
But despite this express requirement, the McClellan FDA recently announced that it would allow food health claims that are supported by far flimsier evidence, including claims supported only by “very limited and preliminary scientific research.” This new regulatory scheme, which goes into effect this month, both legitimizes junk science and demonstrates the FDA’s disdain for enforcing a federal law.
I agree with Commissioner McClellan that inaccurate health and safety information is a “public health hazard.” Yet he and his FDA are failing to practice what he preaches.
The need for congressional oversight of the FDA has never been greater.