| dc.description.abstract | In evaluating the United States drug regulatory system in 1978, Richard J. Crout posed a choice between competing good values: "Do we want scientific rationality or personal freedom? And if we want the latter, are we willing to pay the price of a few frauds here and there?" While the superiority of one policy preference over the other remains uncertain, since the answer largely depends upon the perspective of the "chooser" (i.e. consumer advocate or member/representative of the drug industry), what has become clear over the intervening twenty-five years is that Crout's proposed tradeoff has materialized. Changes in the structure of the law including passage of the Food and Drug Administration Modernization Act of 1997 (FDAMA), FDA's 1997 draft guidance addressing advertisements through broadcast media (such as radio and television communications) incorporated under final regulations promulgated in 1999, recent trends in the courts' First Amendment treatment of commercial speech concerning drugs, and the January 2002 Health and Human Services (HHS) policy requiring FDA legal review of regulatory letters before they are sent to drugmakers, all embody, either in theory or in practice, a loosening of the restrictions placed upon pharmaceutical manufacturers. At the same time, fraudulent promotional practices pervade the marketplace as manufacturers run deceptive ad campaigns marketing drugs as safer and/or more effective than they really are, obscuring and minimizing risks and/or failing to present information about adverse side effects, marketing unapproved uses for an approved drug, and commercializing experimental drugs that have not yet received NDA approval. This paper will explore the impact, if any, had by the changes in the legal landscape upon drugmakers' marketing practices, raising the issues of whether certain unlawful practices may in fact be desirable, and whether the current level of FDA enforcement is appropriate to meet these practices. | en |
