2004S-0170 - Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
FDA Comment Number : EC43
Submitter : Dr. Sarah Sellers Date & Time: 06/07/2004 07:06:52
Organization : The Center for Pharmaceutical Safety
Health Professional
Category :
Issue Areas/Comments
Current CMS policy prohibits reimbursement for pharmacy-compounded drugs manufactured outside our federal system of drug regulation because they have not been approved for safety and efficacy and they are not manufactured in FDA-regulated facilities. Yet, these drugs are paid for under Medicare Part B. In many cases, compounded drugs are being substituted for FDA-approved products for profit reasons without the knowledgeable consent of prescribers who are typically unaware of the risks associated with compounded drugs--including but not limited to: 1) the use of chemicals with undetermined origins, potency and purity 2) the use of non-validated recipes and 3) inadequate end-product testing and analysis.

Sentinel events including patient deaths and population exposures to substandard drugs that pose an 'immediate threat of injury or harm' have raised important public health concerns associated with the growing compounding industry. But while other developed countries have adopted strict rules for compounding, the U.S. has failed to provide effective protections for American seniors under Medicare Part B. It is ironic that the U.S. is currently focused on the safety and quality of HIV/AIDS drugs in Africa and the potential for substandard products to reach consumers through re- importation while critically necessary resources have not been provided to tackle the substandard drug industry that has taken root within our own borders and which is subsidized by U.S. taxpayers.

As CMS moves forward with the implementation of an expanded drug benefit, the amplification of the existing, substandard pharmacy- compounding industry should be anticipated and mitigated.