This article will review the background for concerns regarding consistency in labeling for products marketed in several countries, the pharmaceutical industry's response to those concerns, and will briefly describe a recent Congressional request to the Office of Technology Assessment for a comprehensive study of this subject. Finally, a description will be given of methods used by several multinational companies in achieving labeling consistency on a worldwide basis.
SilvermanM: The Drugging of the Americas.University of California Press (Berkeley), 1976.
2.
SilvermanMLeePRLydeckerM: Prescriptions for Death.University of California Press (Berkeley), 1982.
3.
Letter from Senator Edward M. Kennedy, Congressman John D. Dingell, and Congressman Henry A. Waxman to Mr John H. Gibbons, Director of the Office of Technology Assessment, Washington, DC, Dec 22, 1986; Letter from Mr John H. Gibbons to Technology Assessment Board, Washington, DC, Proposed Assessment of “Drug Labeling in Developing Countries,” March 12, 1987; Letter from Mr John H. Gibbons to Chief Executive Officers, PMA Member Companies, June 15, 1987.
4.
SilvermanMLeePRLydeckerM: Int J Health Serv1986; 16(4):659.
5.
Federal Food, Drug, and Cosmetic Act, § 802, 1986.
6.
International Federation of Pharmaceutical Manufacturers Associations (IFPMA) Code of Pharmaceutical Marketing Practices, IFPMA, Geneva, Switzerland, 1981.
