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FDA Proposal Seems Risky for Patients

FDA Stamp of approval on medicine

The Food and Drug Administration is proposing to allow pharmaceutical companies to contradict official safety warnings in sales presentations to customers.

This new FDA proposal would allow drug makers to present product information that undermines official warnings to customers, as long as it comes from a peer-reviewed journal article. Under the proposal, the FDA would not "object to the distribution of new risk information that rebuts, mitigates, or refines risk information in the approved labeling." Studies must be "well-designed" and "at least as informative as the data sources" the FDA used in generating the official warning.

Although manufacturers support this proposal with the argument that this policy would allow them to share the latest research with doctors and hospitals, many public-health advocates have expressed their criticism. They argue that because individual studies can differ widely in their results, a drug company could easily mislead customers and possibly endanger patients by presenting only a selection of new research.

Sidney Wolfe, founder of Public Citizen's Health Research Group stated that the proposal "seriously undermines FDA authority...Its main supporters are drug companies and their associations, all of which would benefit from being allowed and encouraged to sell more drugs by making them seem safer than FDA has judged them to be."

Read more here.

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