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

relief, or cough and cold symptoms.

While the FDA is making concerted progress to identify and remove products with demonstrated safety and efficacy concerns, an estimated several thousand marketed unapproved products remain on the market. The issue is further complicated because many healthcare providers have likely unknowingly prescribed unapproved prescription drugs for decades. For a small number of these medications, there are no approved alternative therapies and patients -- who are stabilized on them -- depend on these drugs. Physicians and pharmacists consulted for this project stressed that not all unapproved products should be abruptly withdrawn.

The report concludes that information on all products -- approved or unapproved, repackaged or marketed directly -- should be readily accessible to health professionals, plans, CMS, through FDA databases and related resources. It suggests collaboration among these stakeholders to remedy the reporting process and information challenges that are interfering with the availability of information needed to guide important coverage and patient-care decisions.

Avalere's new report, "Part D Formularies: Opportunities for Further FDA/CMS Collaboration," was authored by Jon Glaudemans, Christine Park, and Brian Bruen of Avalere Health, and Patti Manolakis, PharmD. The report is available free of charge at http://www.avalerehealth.net. Avalere will host an audio conference on this new research; information and registration can be accessed at http://www.avalerehealth.net.

Avalere Health is a leading advisory company focused on business strategy and public policy. It serves a diverse client base, which includes Fortune 500 healthcare technology companies, federal government agencies, and major medical foundations. The company is organized into seven substantive areas -- Medicare, Medica
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SOURCE Avalere Health
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