Balancing Act - Pharmaceutical Technology

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Balancing Act
Perhaps Congress can help FDA meet its multiple oversight demands.


Pharmaceutical Technology


A widely cited statistic holds that two-thirds of all drug withdrawals occur within the first three years of release, so several organizations—Consumers Union and the Institute of Medicine among them—have suggested imposing a two- or three-year moratorium on these ads following a drug's release. That would give drug manufacturers and regulators time to gather accurate safety data about the drug and, said Consumers Union, "result in a major reduction in the use of drugs eventually found unacceptably risky."

With Senate approval, PDUFA will now go to the House for a vote—expected in July. Perhaps between now and then, US representatives will impose the advertising moratorium and make the bill one that truly protects the public from unsafe drug claims as well as unsafe drugs.

Michelle Hoffman is editor in chief of Pharmaceutical Technology,


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