Managed care controls could allow for more relaxed FDA approval standards, Covance exec maintains.
Executive Summary
MANAGED CARE DRUG CONTROLS MAKE ACCELERATED APPROVAL ACCEPTABLE MODEL for a larger number of FDA reviews, Covance Senior Scientific Officer William Wardell, MD/PhD, maintained at a July 18 Capitol Hill briefing on an Institute for Alternative Futures report, "Clinical Development 2005." Managed care "with its utilization controls, its databases and potential for quick follow-up has really transformed the landscape [of drug monitoring] and possibly made some of our strictest controls redundant," Wardell suggested.