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Call for Dialog
DOJ AND HHS-IG MARKETING INVESTIGATIONS
MAY ENDANGER PUBLIC HEALTH
by John Kamp
Executive Director
Coalition for Healthcare Communication
Again, the Washington Legal Foundation has pointed to the elephant in the middle of the room and told government and industry alike that good healthcare policy demands that we stop ignoring critical issues about the free flow of health care information.
The recent DOJ and HHS-IG marketing investigations raise at least three compelling public health questions:
- What should be our national policy on prescription drug communications? And, the corollary question: "Who should make that policy? FDA or public prosecutors and plaintiff's attorneys? (I, for one, worry about the ability of government investigators and plaintiff's attorneys to force private settlements on companies when there is no requirement for policy input from professional medical and communication experts, the drug industry, or public policy makers. The charge that FDA was ignored in some or all DOJ settlements is especially disturbing.)
- How do we best balance the FD&C Act focus on drug labeling when public health demands that clinicians use the best available treatments, regardless of whether that use is "on label" or "off label" ?
- How can the federal government continue to censor the dissemination of truthful information by drug companies while:
- Doctors need unrestricted access to state of the art information about all drug treatments,
- Medicare and Medicaid often reimburse the costs of off label treatments, and
- The Supreme Court of the United States continues to remind DOJ, HHS and FDA that government suppression of truthful information violates the First Amendment.
The big question: Where does this challenge to the DOJ go from here?
One can hope that the DOJ avoids the reflex actions of government legal counsel in the past, i.e., ignore it, deny it, delay it, deflect it, defend it, and then -- in the face of a nearly certain First Amendment defeat -- use questionable legal tactics to have it declared moot. These issues are not moot. They are alive and well in health care clinics every day. We must face them now, and begin a constructive dialogue with all stakeholders in search of workable alternatives that honor the First Amendment and the rights of patients across all of America.
While I applaud the WLF for raising the issues and advancing a solution, I worry that moving the authority from one DOJ office to another might be just musical chairs, and that the music may be a dirge. We should strive for solutions driven more by the clinical realties of patient care than by the law. Perhaps there is a third way on this, driven by intelligent experts in medicine, research, clinical practice and economics, as well as enlightened lawyers. The Coalition for Healthcare Communication stands ready to facilitate and participate in such a public policy discussion.
Let the constructive dialogue begin. The patient population should not be forced to continue to wait indefinitely for these issues to be resolved. Lives may depend on it. We can and must do better.
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This article is a reproduction of a letter sent by John Kamp to Rx Compliance Report. © Copyright April, 2005 John F. Kamp. All rights reserved.
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