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Coalition Commentary on Current Issues
January, 2004
ACCME PROPOSAL WOULD PREVENT
CME PARTICIPATION BY TOP PHYSICIANS
The mission of the Accreditation Council for Continuing Medical Education (ACCME) is "the identification, development, and promotion of standards for quality continuing medical education (CME) utilized by physicians in their maintenance of competence and incorporation of new knowledge to improve quality medical care for patients and their communities." In recent years, the ACCME, with input from its parent organizations, its various Councils, and from representatives of government and the healthcare industry, has done much to improve the quality and integrity of continuing medical education in America.
However, the ACCME is now considering proposed changes in its CME regulations that for all practical purposes would block participation in CME events as a planner or faculty member of any physician who receives remuneration from a pharmaceutical or medical device company. The proposed draft would consider any relationship between an FDA-regulated company and a physician, his or her spouse, or even the organization with which the physician is affiliated, a potential "conflict of interest."
Coalition View: If the proposed regulations are adopted the quality of future CME programs will be jeopardized. Because the best and brightest physicians in hospitals, medical schools, research centers and private practice are almost universally involved with FDA-regulated companies as advisors, consultants, speakers, and investigators, the proposed regulations would likely exclude these physicians from participation in related CME activities in areas of their greatest expertise.
The Coalition's position is that disclosure is the answer to concerns over bias and that all parties interested in preserving the quality and value of CME should act to insure that these proposed regulations do not go forward in their present form.
DTC ADVERTISING AND "INFORMATION OVERLOAD"
Since the advent of direct-to-consumer (DTC) advertising of prescription drugs, numerous studies have been undertaken to assess the impact of these ads on physician prescribing practices, consumer behavior, and the doctor-patient relationship.
Research continues to demonstrate that DTC ads inform patients about medical conditions and treatment options, encourage dialogue between patients and physicians, and help to promote compliance with physician-prescribed treatments. These studies also show that direct-to-consumer ads encourage patients to discuss their illness with their doctors for the first time and often do so earlier than they normally would. As the nation's healthcare systems moves towards a more patient-focused system, DTC advertising is becoming more widely used not only by the makers of prescription drugs, but by managed care organizations, hospitals, and doctors.
Currently, the FDA is considering anew whether DTC advertising should require these ads to carry additional risk information.
Coalition Response: In comments to the FDA, the Coalition underscores the value of DTC ads in enhancing the doctor-patient relationship, and expresses concern that requiring too much detailed information in DTC advertising creates "information overload" which will undermine the effectiveness of all DTC advertising, both broadcast and print. The Coalition recommends that DTC ads should focus on the consumer audience, streamline risk information, and encourage consumers to continue discussing the risks and benefits of prescription drugs with their health care providers.
FDA ANNOUNCES REBOUND IN INNOVATIVE DRUG APPROVALS IN 2003
The FDA has announced improved results on overall drugs and biologics it approved in calendar year 2003 versus the previous year, as well as decreases in the time it took the Agency to review and approve most applications.
FDA approved 21 new molecular entities (NMEs) in 2003, up from 17 NMEs approved in 2002. Additionally, FDA says its priority approvals - approvals for priority products of special medical importance - increased as well. There were 14 priority NDAs and 9 priority NMEs in 2003, compared to 11 and 7, respectively, in 2002.
Coalition Response: Clearly, any effort by the FDA to speed the approval process for new drugs, especially those of special medical importance, is a win-win for all involved, including the research-based companies that developed the drugs, the doctor's who now have new weapons to fight disease, and the patients whose medical conditions and quality of life will be improved as the result of these new compounds.
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