Wednesday, March 11, 2015

FDA proposal would allow drug-makers to contradict safety warnings

The Food and Drug Administration is proposing to allow pharmaceutical companies to contradict official safety warnings in sales presentations to customers.
While an FDA warning about a drug’s dangers can scare off buyers, the new proposal would allow the companies to present customers with information that undermines official warnings as long as it comes from a peer-reviewed journal article.
The proposal is supported by pharmaceutical manufacturers, who argue that the policy would allow them to give doctors and hospitals the benefits of the latest research.
But the proposal is drawing an avalanche of criticism from public health advocates who 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.
The proposal “seriously undermines FDA authority,” Sidney Wolfe, founder of Public Citizen’s Health Research Group wrote Wednesday to the agency. “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: http://www.heraldonline.com/news/nation-world/national/article13432754.html#storylink=cpy

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