Part D are available. CMS and the FDA will share this information, which will inform both organizations’ quality improvement projects

CMS issued a guidance document in April 2005 supporting a system of postmarketing data collection for drugs for which national coverage decisions must be made under Medicare Part B (CMS, 2005). Reimbursement is a powerful driver for safety studies. Although Medicare will be collecting data on Part D drugs, it will have no authority to make coverage decisions based on that information (Gottlieb, 2005).


Alastair Wood of Vanderbilt Medical School discussed new approaches to improve the current adverse event reporting systems. He described MedWatch and other reporting systems as being set up to detect rare events and said that what is needed is the capture of “high-frequency, high-impact” cases that are not detected with the current systems. “One approach,” said Dr. Wood, “is to have incentives for long-term safety studies.” This, however, would cause a long delay before drug approval and would not be cost-efficient. It would also entail discussion about which drugs would be subject to long-term study. Another approach is to conduct long-term safety studies after approval. This again requires consideration of which drugs would be chosen for study or whether all drugs should be studied.

One way to ensure the completion of safety studies is to offer extended exclusivity to companies that have acquired data to demonstrate that their drug is safe in the long term, offered Dr. Wood. This makes the drug more valuable to consumers and to the company. Most importantly, Dr. Wood said, “We need to move to a reward-based system that rewards demonstrated safety.” In his proposal, drugs that lacked long-term safety data would be clearly identified as such. In this way, physicians could make the appropriate choice of medication with their patients. A fundamental issue would be the design of these safety studies, which under Dr. Wood’s proposal would require FDA approval. In other words, extended exclusivity would be offered only for well-designed studies structured to answer important clinical questions.

Forum member Robert Califf proposed a clinical trial “light” system, in which new users of drugs would be notified about known drug risks and benefits. The system would indicate that the drug being prescribed had recently been approved but that information concerning both risks and benefits was being developed. Patients would be provided information to report any adverse events and asked to participate in follow-up studies concerning the medication.

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