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FDA Proposal About Drug Marketing Puts Patients at Risk

Proposed guidance from the U.S. Food and Drug Administration (FDA) is receiving significant criticism from patient safety advocates. It would allow pharmaceutical companies to inform doctors that the prescription labels approved by the FDA overstate a medication’s risks by distributing peer-reviewed articles and by having discussions with doctors.

As Reuters reports, the FDA maintains that the revised drug label guidance accounts for the fact that the risks associated with a particular medication change over time. Under the proposal, drug companies could provide health care providers with data suggesting that side effects are less severe than stated on the label or even “call into question a causal relationship between a drug and an event in the approved labeling.”

Pharmaceutical companies would not be able to distribute information about new risks or side effects, as any changes must be directly reported to the FDA. Nonetheless, critics of the proposal maintain that it would still undermine the legitimacy of FDA-approved drug labels.

“[This proposed guidance is reckless and seriously undermines FDA authority,” Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, wrote in a recent letter to the Department of Health and Human Services. “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.”

According to Public Citizen, 99 percent of the 1,782 comments submitted to the FDA also oppose the proposal. It offered the following examples:

  • “This is a misguided FDA proposal that could result in physicians relying not on approved warning labels but on information provided by drug companies that may be more concerned with profits than patients.”
  • “Drug reps stretch the truth more than enough.”
  • “How can this be considered in any way? Where I come from you do not let the fox in the hen house.”

The FDA has stated that it is considering all of the feedback it has received. We will be closely tracking the status of the proposed guidance. Please check back for updates.

If you or someone you love has been seriously injured by a dangerous or defective drug or medical device, don’t hesitate to contact a San Diego product liability attorney at the Law Offices of Robert Vaage for a free consultation.