WASHINGTON -- The White House Council on Competitiveness onTuesday will release a report recommending sweeping changesof the drug approval process, according to a representative ofthe Council.
The Council, a special panel established by President Bush toreview the operations of federal agencies, reportedlydeveloped the package in cooperation with the Food and DrugAdministration.
The recommendations reportedly will include:
-- Use of private contractors -- either private researchlaboratories or university medical centers -- to handle theentire application process for allergy drugs, analgesics, anti-inflammatory drugs and antibiotics. The FDA would only haveto review the private contractor's findings and decide whetherto approve a drug.
-- Elimination of the requirement for submission of aninvestigational new drug application before a company canbegin Phase I trials. Instead, companies would obtain approvalfrom local institutional review boards, bodies that overseeguidelines for human experimentation in hospitals.
-- Approval for drugs that treat serious diseases prior to filingby companies of full efficacy data.
-- Harmonization of the U.S. drug approval process with othercountries so that drug approvals granted elsewhere could alsoapply to the U.S. market.
Proponents are expected to argue that the changes will shortenby years the time required to move a drug through the clinicand approval processes.
-- Kris Herbst BioWorld Washington Bureau
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