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PNHP RESOURCES

Expert says FDA draft guidance would let drug industry tell doctors medications are safer than they really are

By Public Citizen
Press release, Aug. 15, 2014

WASHINGTON – The U.S. Food and Drug Administration (FDA) recently issued draft guidance that would let the pharmaceutical industry essentially circumvent drug labeling rules and tell doctors that its products have fewer risks than those described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 issue is discussed by Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, in an article published in JAMA Internal Medicine today.

In June 2014, the FDA issued draft guidance for the industry on distributing scientific and medical publications about the risks of approved medication and biological products.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 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.

Wolfe says that to protect patients and the public health, when new information supports a reduction in risk, the company should inform the FDA and provide the evidence, as is required under current regulations. If the agency is convinced, the label can be changed.

Off-label risk reduction is the wrong approach, Wolfe writes. The article also discusses how people can voice their opinions to the FDA on this by Aug. 25, when the docket on the guidance closes.

The URL link for commenting on the FDA draft guidance is here:
http://www.regulations.gov/#!documentDetail;D=FDA-2014-D-0758-0001

Dr. Wolfe’s article is available here:
http://archinte.jamanetwork.com/article.aspx?articleid=1897291

"Proposed US Food and Drug Administration Guidance for Industry on Distributing Medical Publications About the Risks of Prescription Drugs and Biological Products: A Misguided Approach," by Sidney M. Wolfe, M.D., JAMA Internal Medicine, Aug. 15, 2014

Public Citizen has initiated a petition that asks the FDA to not permit Big Pharma to undermine information about pharmaceutical risks:
http://action.citizen.org/p/dia/action3/common/public/index?action_KEY=12559&start=150