Off-Label Drug Use To Receive CMS Scrutiny, McClellan Says
This article was originally published in The Pink Sheet Daily
Executive Summary
The Centers for Medicare & Medicaid Services plans to improve its collaborations with outside experts to better understand Rx drug use among seniors. The agency will share the information with providers.
|
The Centers for Medicare & Medicaid Services is interested in learning more about the risks and benefits of off-label prescription drug use, Administrator McClellan says. CMS intends to have "better collaborations with [the National Institutes of Health] and other experts to find out what works and what doesn't when it comes to the medicines that seniors use," McClellan said. "Very often, medicines are used under off-label conditions or...in combination with many other treatments where we just don't know if there are important interactions or maybe important benefits or problems for particular subgroups of seniors," he continued. "We're looking for ways to understand that better and get information out. You'll be hearing about that from us in the coming weeks and months," he said. CMS caused some concern among oncologists when, in February 2003, it initiated a review of off-label use of Sanofi-Synthelabo's Eloxatin and Pfizer's Camptosar for colorectal cancer. After gathering information through public comment and meeting with industry representatives, CMS did not make a ruling by the January decision deadline. The matter remains officially under review. - Scott Steinke |