WASHINGTON -- The chairman of a House oversight committeeon Thursday charged that the White House is pressuring theFDA to expand the scope of drug approval reforms despite theagency's "serious misgivings" that this will endanger publichealth.
Rep. Ted Weiss, D-N.Y., chairman of the human resources andintergovernmental operations subcommittee, made the chargeat a hearing on the administration's plans to speed up the drugapproval process.
FDA Commissioner David Kessler did not respond directly to thecharge, telling the committee that there is a "tremendouscommitment ... at FDA and throughout the government ... tospeeding the availability of important therapies."
The proposed reforms originated with the Council onCompetitiveness, which is chaired by Vice President DanQuayle. "Our preliminary investigation suggests that many atthe FDA also have serious misgivings about the Quayleproposals, but have been overruled by the White House," saidWeiss.
Last Aug. 30, Kessler approved a draft regulation that wouldaccelerate drug approvals for life-threatening, very serious orseverely debilitating conditions. In mid-February, according toa House staff member who requested anonymity, the WhiteHouse told the FDA it wanted to broaden the definition ofserious diseases to cover chronic, but not life-threatening,diseases for which there is no alternative therapy.
The House committee has obtained a copy of an FDA memo,written in mid-January, that says that "to suggest that anyillness with no alternative therapy may be serious isdisingenuous and will cause the agency to lose credibility,"according to the staff member.
Kessler said the draft of the accelerated approval regulationwill be published for public comment "soon." The Institute ofMedicine of the National Academy of Sciences will complete inabout six months a review of a recommendation to makeexpanded use of advisory committees in the drug approvalprocess, he added.
The FDA will soon complete a "memorandum of need" thatdefines the scope of work expected from outside contractorswho would perform clinical review of some drugs, Kessler said.In the meantime, the FDA is identifying qualified contractors.
The FDA plans "shortly" to seek broad comment on a proposalthat Institutional Review Boards be given authority in somecases to review and approve investigational new drugapplications for human clinical trials. Kessler also said he hasestablished a task force to review the FDA's efforts toharmonize its regulatory activities with other countries, andthat the FDA will host the second International Conference onHarmonization (ICH-II) in 1993.
-- Kris Herbst BioWorld Washington Bureau
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