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FOR IMMEDIATE RELEASE                                                               
Wednesday, February 16, 2005
CONTACT:

Lindsey Capps/Stark, 202-225-5065
Drew Nannis/Berry, 202-225-4076

REPS. STARK AND BERRY INTRODUCE BILL TO PROTECT PATIENTS FROM DANGEROUS PRESCRIPTION DRUGS

The PhRMA Act Would Impose Criminal Penalties on Pharmaceutical Company Executives who Knowingly Withold Information on Drug Safety

WASHINGTON, DC -- 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) 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.
 
“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.”
 
“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.”  
 
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.
 
“Congress has made it clear that corporate CEOs should be held personally accountable for willful accounting irregularities,” said Stark. “It is only right that pharmaceutical executives should be held accountable when they willfully disregard the risks of their drugs and thousands of Americans die.”
 
“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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