P o l i c i e s a n d P o l i t i c s their other customers. These guidelines include codes of conduct adopted by the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Advanced Medical Technology Association (AdvaMed) as well as professional associations such as the American Medical Association, American Academy of Family Practice and others. Voluntary industry guidelines have helped clarify how companies should interact with their customers. However, given the proliferation of guideline-issuing bodies, in addition to corporate integrity agreements and continuing legislative and regulatory threats, the environment for drug advertising and promotion promises to be challenging for the foreseeable future. For a summary description of the following selected cases and settlements, see www.mahf.com: TAP Pharmaceuticals (Lupron); Parke-Davis/Pfizer (Neurontin); Orphan Medical (Xyrem); Purdue-Frederick (OxyContin); Intermune (Actimmune), and Pfizer (multi-drug settlement). 4* Policies and Politics: A Perspective In the face of spiraling healthcare costs during the 1990s and into the new millennium, a confluence of events occurred which dramatically changed the environment for policy development and the regulation of communications. The first event was formation of an ad hoc task force led by the American Medical Association to examine relationships between the pharmaceutical industry and the medical profession, particularly in regard to industry support for continuing medical education. A chance remark by an FDA representative at an annual meeting of the task force led to the discovery of a draft document that proposed draconian FDA controls over the CME enterprise. Several members of the communications industry recognized the important First Amendment implications of the draft and immediately formed a coalition to address the matter. After a brief skirmish, the draft document was withdrawn. However, the emergence of other challenges resulted in the persistence of the Coalition for Healthcare 49
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