Public Citizen expert slams aspects of FDA draft drug labeling guidance

The US Food and Drug Administration recently issued draft guidance that would let the pharmaceutical industry essentially circumvent drug labeling rules and tell doctors that its products have fewer risks than those described in the FDA-approved labeling.

This is discussed by Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, in a Journal of the American Medical Association (JAMA) Internal Medicine article.

In June 2014, the FDA issued draft guidance for the industry on distributing scientific and medical publications about the risks of approved medication and biological products. According to Dr Wolfe, the guidance, as written, would allow pharmaceutical companies that believe that the FDA-approved labeling information overstates a medication’s risks to tell doctors that the risks are in fact, lower. Company salespeople could inform physicians of the purportedly lower risks by distributing peer-reviewed articles – without the agency either reviewing the data or approving it – and discuss with doctors the information about the lower risks.