PFIZER: Gave Generously During Drug Approval Hearings
In an article suggesting that men are "dying for sex" because the Food and Drug Administration approved Viagra "perhaps too quickly," U.S. News & World Report reports that Pfizer Inc. and other drug companies "lobbied Congress hard against beefing up" surveillance guidelines. According to U.S. News, Pfizer poured money into the campaign coffers of lawmakers during congressional hearings on reforming Food and Drug Administration policy -- a move that may have paid off for the company down the road when it went to market Viagra. In 1997, lawmakers passed the FDA Modernization Act (FDAMA), which allowed the FDA to speed up the approval process for lifesaving drugs. U.S. News reports that during the FDAMA and another FDA policy-related hearing, Pfizer's PAC donated $288,050 to campaigns and contributed $609,550 in soft money, "making it the biggest giver among pharmaceutical companies." The drug industry as a whole also poured money "into congressional campaign coffers -- $8.3 million in 1997 and the first nine months of 1998." In addition, U.S. News reports that in September of 1997, "Pfizer delivered several boxes of clinical data to the FDA." But not even two months later, the FDA decided not to consult "a cardio-renal committee" it had scheduled to meet in January 1998 to review Viagra's application. While Norman Stockbrigde, Viagra's principal FDA reviewer, said he believed Pfizer had submitted satisfactory data, committee member Lemuel Moye, said, "It's the first time such a drug has been approved, and I'm surprised (we didn't see the application)" (Brownlee/Schultz, 1/11 issue).
This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.