EXPEDITED APPROVAL LEGISLATION SUPPORTED BY KEY REPUBLICANS

Executive Summary

EXPEDITED APPROVAL LEGISLATION SUPPORTED BY KEY REPUBLICANS, but Democrat health legislators are questioning the need for such a bill. Rep. Bliley (R-Va.), ranking minority member of the House Energy & Commerce/Oversight Subcommittee, said he is working with other legislators on an expedited approval bill. Bliley told a June 12 Health Subcommittee hearing on the Edwards Advisory Committee to FDA (see related story, p. 5) that he is "working with others to draft legislation that will speed up the drug approval process at the FDA for any drug with patients in danger." The Virginia Republican urged his colleagues to support the effort "so that we can fight the barriers and inefficiencies of the FDA drug approval process." However, key Democrats on the Energy & Commerce Committee are not supportive of such legislation. Committee Chairman Dingell (D- Mich.) reportedly believes there is no need for statutory changes because FDA can speed the approval process administratively, as it has for AIDS and cancer drug reviews. Health Subcommittee Chairman Waxman (D-Calif.) is said to oppose legislation that would relax safety and efficacy standards for approval. The idea for legislation directed at expediting FDA approvals derives from the debate over conditional approval. However, that terminology has been rejected on the Hill because it indicates that an approval is not final. During a Senate hearing on the Edwards Committee report, Sen. Hatch (R-Utah) announced his intention to pursue expedited approval legislation ("The Pink Sheet" May 20, p. 9). The ranking Republican on the Labor & Human Resources Committee requested the help of former staffer Lawrence Horowitz, MD, a member of the Edwards Committee, which recommended that FDA approve drugs with less rigorous standards for desperately ill patients willing to assume greater risk. However, Labor & Human Resources Committee Chairman Kennedy (D-Mass.) reportedly believes that FDA can decide to expedite approvals for such circumstances by pursuing an administrative route.