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Avalere Report Shows Unapproved Prescription Drugs Dropped from CMS Formulary Reference File
Date:5/15/2008

WASHINGTON, May 15 /PRNewswire/ -- A new report, funded and released by Avalere Health, showed that CMS dropped more than 1,500 drug codes from its CY 2008 Part D Formulary Reference File. In response, commercial health plans dropped many of these drugs from their Medicare offerings in 2008, resulting in significantly smaller Part D formularies in 2008 compared to 2007. The CMS action was driven in part to remove hundreds of prescription drugs that were being marketed without FDA approval.

There is no definitive list of such marketed unapproved drugs, making it difficult for patients, pharmacists, and plans to determine which drugs are being marketed without FDA approval. Since, with few exceptions, the Medicare Modernization Act limits Part D subsidies only for those drugs with formal FDA approval, the Part D program is also dependent on knowing which drugs are being marketed without FDA approval. In addition to the several hundred marketed unapproved drugs removed from the CMS Formulary Reference File, the Avalere research confirmed the existence of several thousand drugs being marketed in the U.S. that have never been approved by the FDA.

"CMS, patients, physicians, insurance plans and other stakeholders need a clear and timely accounting of marketed unapproved drugs," said Jon Glaudemans, senior vice president of Avalere Health and co-author of the paper. "Up-to-date and user-friendly information about all marketed medications (approved and unapproved) and withdrawn drugs would improve clinicians' ability to prescribe safe and effective medications."

John A. Gans, PharmD, Executive Vice President and Chief Executive Officer at the American Pharmacists Association (APhA), commented on the Avalere Health research. "Since the inception of the Medicare Part D prescription drug benefit, pharmacists have played an integral role in ensuring the successes of the Medicare Part D prescription drug benefit. This new research conducted independen
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SOURCE Avalere Health
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