Coming to grip with pharmacoeconomics

WASHINGTON - FDA is considering forming a task group with PhRMA and other industry representatives to discuss terms of a guidance document on pharmacoeconomic claims, according to Laurie Burke, an epidemiologist at the agency's Division of Drug Marketing, Advertising & Communications (DDMAC).

The task group would be part of a larger effort to solicit outside involvement in FDA's implementation of provisions in the FDA Modernization Act of 1997 that require the agency to adopt new standards for economic claims. The law instructs FDA to require that economic claims be based on "competent and reliable" information, a much looser standard than the requirement for evidence from well-controlled clinical trials that the agency has applied in the past...