adverse publicity would accompany any notice of improper promotion. Two major advertisers suspended journal advertising awaiting clarification of the rules. The pocket-sized journals, Medical Economics and Modern Medicine, converted to a page size comparable to that of JAMA to accommodate the need for expanded space for brief summary. PMA went to court to overturn such requirement as that the generic name appear every time with the brand name in promotional text. For all the alarm sounded when the new regulations were first announced, and criticism in the trade press and at hearings held to examine the provisions the FDA had devised to implement Kefauver-Harris, the industry and its advertising agencies eventually learned to live within this restrictive promotional environment. PMA won its case on generic name appearance but the other aspects of the new regulations went unchallenged. Pharmaceutical manufacturers soon saw the commercial logic of avoiding confrontation with the FDA over promotional rules when this agency also held the power of approval on new drugs worth millions in sales. Moreover, as the industry proceeded under Kefauver-Harris—preclearing with FDA introductory campaigns on new drugs, and observing how the rules would he interpreted through a series of actions that the FDA took against promotions judged to be in violation—advertisers and their agencies became adept in producing effective promotion within the 1963 guidelines. Over the years, FDA has expanded its control over promotion, case by case, extending, for example, to such things as press releases and medical education. It was not until 1992, when the FDA attempted to govern continuing medical education with extensive regulations, that manufacturers' First Amendment rights to distribute truthful information, exempt from FDA clearance or scrutiny, became an issue and the FDA's power and role in information dissemination was challenged in the courts by the Washington Fegal Foundation. Since Kefauver-Harris, pharmaceutical advertising has been one of the most regulated fields of commercial promotion. Regardless of this inhibiting influence—requiring, for example, the display on all materials of a brief summary, which grew in most instances into a one- or two-page full
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