AMA Endorses Several APA-Sponsored Proposals

Enhancing access to FDA data: Also written in response to an APA/AACAP resolution and approved by the house was a report by the Council on Scientific Affairs titled “Enhanced Physician Access to Food and Drug Administration Data.”

That report calls on AMA to (1) urge the Food and Drug Administration (FDA) to issue a final rule, as soon as possible, implementing modifications to the format and content of the prescription drug package insert with the goal of making the information more useful and user-friendly to physicians; (2) urge the FDA to collaborate with physician organizations to develop better risk communication vehicles and approaches; (3) urge the FDA to apply new tools to gather data after drugs are approved for marketing, including a broader use of targeted postapproval studies, institution of active and sentinel-event surveillance, and data mining of available drug-utilization databases; (4) monitor the design and implementation of any independent drug-safety board that may be instituted within the FDA, or external to the agency, and respond as appropriate; and (5) support adequate funding to implement an improved FDA postmarketing prescription drug surveillance process.

Direct-to-consumer advertising (DTCA): A number of resolutions on drug marketing to consumers, including one submitted by APA and AACAP, were debated during the meeting. Some of those resolutions called for an outright ban on direct-to-consumer advertising.

The APA/AACAP resolution asks for an AMA report on the subject that would explore strategies for minimizing the potential harmful effects of DTCA. Among these possible strategies is a “quiet period” immediately following drug approval during which advertising would not be permitted, allowing time to monitor patient safety and efficacy.

During reference committee hearings, David Fassler, M.D., the AACAP delegate and a member of the Section Council on Psychiatry, noted that at least one drug company had already voluntarily agreed to such a policy.

All of the resolutions on DTCA were referred to the AMA Board of Trustees with the likelihood that they would be considered together in a report by the Council on Scientific Affairs, as requested by the APA/AACAP resolution.

Educating physicians about Medicare Part D: Rounding out the list of psychiatry-sponsored actions approved by the AMA last month was a resolution requesting the AMA to prepare a report on educational programs for physicians around issues related to the new Medicare Part D prescription-drug benefit. That resolution also asks the AMA to “make available appropriate educational materials targeted for physicians on Medicare Part D issues, so that they may best assist patients and effectively meet their responsibilities under Medicare Part D laws and regulations.”

Benzodiazepine restrictions under Medicare: The resolution asks the AMA to “work to end the exclusion of medications of the benzodiazepine class from reimbursement” under the new Part D benefit.

Depression and physician licensure: This resolution asks the AMA to“ recommend that physicians who have major depression and seek treatment not have their medical licenses and credentials routinely called into question but instead have decisions about their licensure, credentialing, and recredentialing be based on professional performance.”

It further calls on the AMA to make the resolution known to state medical licensing boards and to hospitals and health plans involved in physician credentialing and recredentialing.