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There is no definitive list of such marketed unapproved drugs, making itdifficult for patients, pharmacists, and plans to determine which drugs arebeing marketed without FDA approval. Since, with few exceptions, the MedicareModernization Act limits Part D subsidies only for those drugs with formal FDAapproval, the Part D program is also dependent on knowing which drugs arebeing marketed without FDA approval. In addition to the several hundredmarketed unapproved drugs removed from the CMS Formulary Reference File, theAvalere research confirmed the existence of several thousand drugs beingmarketed in the U.S. that have never been approved by the FDA.
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"CMS, patients, physicians, insurance plans and other stakeholders need aclear and timely accounting of marketed unapproved drugs," said JonGlaudemans, senior vice president of Avalere Health and co-author of thepaper. "Up-to-date and user-friendly information about all marketedmedications (approved and unapproved) and withdrawn drugs would improveclinicians' ability to prescribe safe and effective medications."
John A. Gans, PharmD, Executive Vice President and Chief Executive Officerat the American Pharmacists Association (APhA), commented on the AvalereHealth research. "Since the inception of the Medicare Part D prescription drugbenefit, pharmacists have played an integral role in ensuring the successes ofthe Medicare Part D prescription drug benefit. This new research conductedindependently by Avalere Health brings to light important issues regarding theavailability of information regarding unapproved drug products, changes toprescription drug coverage, and the resulting impact on patients, pharmacists,and others. APhA views this work as a positive contribution to healthcarediscussions on improving medication use and advancing patient care."
CMS reduced the number of drugs on its "Formulary Reference File" -- thetool used by Part D plans to shape their Part D drug formularies -- from 7,100to 5,500 in 2008. Using its DataFrame(R) database tool, CMS's public use filedata, and public reference materials from the FDA, Avalere researchers soughtto explain why drugs were deleted from this CMS file, what types of drugs weredropped, and how pharmacists, patients, and health plans may have beenaffected by CMS' changes.
Avalere found that CMS dropped drug codes from the Formulary ReferenceFile that were connected to: a) unapproved FDA drugs; b) discontinued drugs;c) Part A or Part B products; d) products with redundant codes; and e)products not reimbursable under statute (such as nonprescription medications,and agents used for anorexia, weight loss, weight gain, or for cosmeticpurposes).
CMS's changes to the CY 2008 Reference File had significant ripple effectsto plans, patients, physicians, and pharmacists. For patients, changes in theformularies could result in their need to pay out-of-pocket for non-covereddrugs, or transition to a comparable drug. Plans have the authority to decidewhether or not to pay for the deleted drugs.
Unapproved prescription drugs listed in the formularies were likely olderproducts cleared for marketing before 1962, the year that the FDA beganrequiring proof of efficacy. Before the requirement, drugs were approved basedon safety, in compliance with the Federal Food, Drug, and Cosmetic Act of1938. The products in this category were overwhelmingly medications used forsedation, pain
