On May 14, 2008, Avalere Health released a self-funded research report examining CMS’ decision to drop 1,500 drug codes from the CY 2008 Part D Formulary Reference File, the tool used by Part D plans to shape their Part D drug formularies. In response, commercial health plans dropped these drugs from their Medicare offerings in 2008. The CMS action was driven in part to remove hundreds of prescription drugs that were being marketed without FDA approval.

Avalere found that CMS dropped drug codes from the Formulary Reference File that were connected to: marketed unapproved FDA drugs; over-the-counter drugs; discontinued drugs; Part A or Part B products; products with redundant codes; and products from other Part D-excluded categories, such as nonprescription medications and agents used for anorexia, weight loss, weight gain, or for cosmetic purposes. There is no definitive list of such marketed unapproved drugs, making it difficult for patients, pharmacists, and plans to determine which drugs are or are not FDA-approved.

Unapproved drugs listed in the formularies were likely older products cleared for marketing before 1962. 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.

Join Avalere Health for a 90-minute educational audio conference that will highlight:

• The impact of CMS’ decision to modify the Formulary Reference File on Part D plans’ formulary designs
  
• Current FDA and CMS strategies to eliminate Part D coverage of marketed unapproved drugs
  
• Resources available to healthcare providers and pharmacists seeking additional information on marketed unapproved drugs
  
• Opportunities for further FDA and CMS collaboration to share more information about marketed unapproved drugs

• Jon M. Glaudemans - Speaker
  Senior Vice President, Avalere Health
• Patti Manolakis, PharmD - Speaker
  President, PMM Consulting
• Cynthia Tudor, Ph.D. - Speaker
  Director, Medicare Drug Benefit Group, CMS
• Mike Levy - Speaker
  Director, Division of New Drugs and Labeling Compliance, FDA
• Harry P. Hagel - Commenter
  Senior Vice President, Government and Professional Affairs, American Pharmacists Association
• Claudia Schlosberg - Commenter
  Director of Policy and Advocacy, American Society of Consultant Pharmacists

*For information, please call Tom Moreno at 202.207.3471 or email tmoreno@avalerehealth.net.

Cancellation Policy: To receive a refund, notice is required at least seven business days prior to the audio conference. With proper notice, fees are refunded minus a $40 service fee. No refunds are given for cancellations received with less than seven days notice. Avalere Health reserves the right to cancel or reschedule an audio conference due to unforeseen circumstances.