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WASHINGTON, D.C. – Today, as the U.S. Food and Drug Administration convenes a special three-day expert advisory meeting on the safety of Cox-2 inhibitors (Vioxx, Celebrex, Bextra), Reps. Pete Stark (D-CA) and Marion Berry (D-AR, 1st) introduced a bill in Congress to impose criminal penalties on CEOs and top executives of pharmaceutical manufacturers who knowingly withhold information on the dangers of their drugs.
“In the past six months, Vioxx was pulled off the shelves for causing heart attacks and new warnings were added to antidepressant drugs because of the risk of suicide among children,” said Rep. Berry. “In many cases, the evidence suggests that the manufacturers knew of their deadly consequences, but hid this information from consumers and the FDA. That’s a clear sign that the FDA’s current program to enforce drug safety laws is inadequate.”
“It is time for Congress to act to make corporate leaders personally liable for bottom line decisions that threaten patient safety,” said Rep. Stark. “By imposing jail time and personal fines, our bill would restore corporate responsibility within the pharmaceutical industry and protect consumers from future harm.”
The Pharmaceutical Research and Manufacturers Accountability Act or PhRMA Act would create new enforcement mechanisms in the Federal Food, Drug, and Cosmetic Act to impose jail sentences and large fines on CEOs and other drug company executives for failing to disclose safety concerns or deadly reactions to their drugs.
“It is time for pharmaceutical companies to realize the term ‘corporate responsibility’ is more than a slogan,” Berry added. “It must apply to the life and death decisions CEO’s make and must punish those who make the wrong decision merely to increase revenues.” |
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