FDA issues advice for early stages of clinical drug development

February 1, 2006

The Food and Drug Administration's (FDA) steps to advance the earliest phases of clinical research in the development of innovative medical treatments will have little short-term impact on managed care plans.

NATIONAL REPORTS-The Food and Drug Administration's (FDA) steps to advance the earliest phases of clinical research in the development of innovative medical treatments will have little short-term impact on managed care plans.

"Longer term, it will impact managed care as the new products come to market sooner," says MHE Editorial Advisor Perry Cohen, PharmD, FAMCP, principal, The Pharmacy Group, Glastonbury, Conn.

FDA's goal is to improve the process for bringing safe and effective drugs for potentially serious and life-threatening diseases, such as cancer, heart disease and neurological disorders, to the market.

"Currently, nine of our 10 experimental drugs fail in clinical studies because we cannot accurately predict how they will behave in people based on laboratory and animal studies," HHS Secretary Mike Leavitt said in an FDA statement. "The recommendations . . . will help more researchers conduct earlier, more-informed studies of promising treatments so patients have more rapid access to safer and more effective drugs."

Says Alexander M. Gilderman, PharmD, VP, clinical programs, at La Jolla, Calif.-based Ventegra, a managed care contracting services organization: "These guidelines have the potential to identify early on those drugs that have the most potential for success. [They] won't be useful from a managed care perspective unless the FDA eventually looks at all phases of drug discovery such that guidelines are provided to improve the other phases-in particular, providing guidelines to address safety concerns that appear after a drug is marketed."