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JOINT STATEMENT on the Institute of Medicine (IOM) Report on
“The Future of Drug Safety.”
FROM: The COALITION FOR HEALTHCARE COMMUNICATION (“Coalition”) &
The AMERICAN ASSOCIATION OF ADVERTISING AGENCIES (“4As”)
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Coalition for Healthcare Communication
John Kamp
202) 719-7216
or
Harry Sweeney
(215) 625-0111
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Amer. Assn. of Adv. Agencies
Adonis Hoffman
(202)331-7345
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The Institute of Medicine has made a significant contribution to the public debate about prescription drug safety. After holding three meetings and a workshop on the topic, its expert committee has produced a number of observations and recommendations that will better inform legislators, regulators, policy makers, the professions, the media, and the public about the important and complex issues that must be factored in to future decision-making on the subject.
The Coalition and 4As applaud the recommendation for a permanent Advisory Committee on Communications, a principal recommendation of the Citizen Petition filed by the Coalition with the FDA earlier this year.
Moreover, the IOM Report recommends another significant step forward, naming and tasking a new office of drug safety with a major communications role. While it is not clear that a new drug safety office is essential, the IOM report is correct in observing that if there is one, it should be an office named and focused as recommended: Office of Drug Safety Policy and Communication. The Report reflects the fact that doctor/patient communication is at the center of the implementation of an effective and efficient drug safety program. We trust that implementation of such a program will involve adequate staff of professional writers and communications specialists who understand how to create appropriate medical and health messages, delivered by select media that will enable optimum communications to both doctors and patients. We also trust that professional communication experience in this field will be considered an asset, and not a potential conflict of interest.
The Committee's suggestion that new drugs be recognized and labeled graphically as such,deserves serious consideration and public discussion before implementation. As has previously been suggested by the Coalition and 4As, the use of symbols on packaging and labels can quickly communicate significant information in many contexts, and may well be of particular value here. Whether or not a temporal (i.e. 2-year) guideline or some other metric would best accomplish the goal to alert users to the novelty of a medication is a matter deserving of further discussion. However, the group's specific proposal for a two-year direct-to-consumer (DTC) advertising blackout clearly violates First Amendment protections of speech. Moreover, the use of a new drug symbol requires significant study and, if adopted, careful administration. And, of course, the First Amendment requires that any such technique be carefully tailored to insure that its intended outcome is effective, limited in scope, and not counterproductive.
Finally, new legislative authority over the labeling and advertising of drugs may not be necessary. However, as noted in the Coalition's Citizen Petition, the FDA should revise its rules for direct-to-consumer communications to recognize that the information needs of doctors and patients are distinct. New consumer rules should be created that focus on what consumers – as opposed to doctors -- need to know, to begin a dialog with healthcare professionals who ultimately must decide on the appropriateness of any given medication.
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Copyright ©2006 Coalition for Healthcare Communication. All rights reserved.
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