SENS. ENZI AND KENNEDY INTRODUCE DRUG SAFETY BILL
Months of negotiations have come to an end as the top Republican and Democrat on the Senate Health, Education, Labor and Pensions (HELP) Committee finally introduced their comprehensive overhaul of the nation's drug safety efforts.
The "Enhancing Drug Safety and Innovation Act," drafted by Chairman Mike Enzi (R-Wyo.) and ranking member Edward Kennedy (D-Mass.), improves the FDA's oversight of drugs once they are on the market and imposes on the industry new safety planning requirements before launching a drug, the lawmakers said.
"The FDA needs better authorities and more resources to monitor and manage drug safety after drug approval," Kennedy said, "and this bill gives FDA both."
Enzi said the bill would "raise the bar to ensure that drug safety is not an afterthought, but an integral part of the process from the very beginning. It requires drugmakers to engage in better safety planning before a drug is approved for release to the public, and will improve both the understanding of and response to risks that arise after a drug is on the market."
The bill would also tighten conflict-of-interest rules for FDA advisory committee members and establish a public-private partnership to improve drug development and evaluation and advance the FDA's Critical Path Initiative.
The FDA has been under pressure to make changes to its drug review program, especially its habit of granting conflict-of-interest waivers to advisory board members. It has faced growing criticism for its handling of Vioxx and other drugs, with critics arguing that the FDA review process is too slow and incomplete to catch potential problems.
Introduction of the Enzi-Kennedy bill did little to calm the agency's critics, however. Sidney Wolfe, director of Public Citizen's Health Research Group, immediately denounced the bill for not repealing the user fees drugmakers pay to the FDA when they submit a new drug application and for not including a provision removing the Office of Drug Safety from CDER and making it independent.