In the wake of a major court decision, the US Food and Drug Administration has issued new guidelines for public comment, covering how pharmaceutical companies present drug risks to doctors. In a freely-distributed commentary published in JAMA Internal Medicine, Public Citizen’s Sidney Wolfe writes that the FDA “has now tilted toward protecting industry’s commercial speech and away from protecting patients from the risks of prescription drugs and biological products.”
The new draft guidelines state that “FDA does not intend to object to the distribution of new risk information that rebuts, mitigates, or refines risk information in the approved labeling, and is distributed by a firm in the form of a reprint or digital copy of a published study, if the study or analysis and the manner of distribution meet the principles set out below…”
Those principles, writes Wolfe, give too much leeway to pharmaceutical companies. “When evidence supports a reduction in the risk associated with the use of a prescription drug or biological product, the manufacturer should send the evidence to the FDA, state the basis for the reduction in risk, and request a labeling change,” writes Wolfe. “The draft guidance, however, may encourage companies to promote the supposed evidence of lower risk in a peer-reviewed article directly to physicians, without the FDA ever having been informed[.]”
Wolfe writes that the draft guidance “has the potential to undermine the FDA’s drug safety laws and regulations and should be changed.” The FDA is accepting public comments on the guidelines until August 25, 2014.
Proposed US Food and Drug Administration Guidance for Industry on Distributing Medical Publications About the Risks of Prescription Drugs and Biological Products: Misguided Approach (Wolfe, Sidney M. JAMA Intern Med. Published online August 15, 2014. doi:10.1001/jamainternmed.2014.4547)
Guidance for Industry Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices (U.S. Department of Health and Human Services Food and Drug Administration, June 2014)
Regulations.gov (For electronic comment submissions.)