Export Provisions of the Food and Drug Act This

This paper will discuss some aspects of the laws concerning the export of non-approved drugs by U.S. manufacturers to European countries. The first part will provide a brief background to the issue, describing the development of the modern pharmaceutical industry and exports. The second part of the paper will discuss some of the most important business issue involved in the export of drugs. The third part of the paper will consider some of the important ethical issues concerning the export of drugs. The fourth part of the paper will examine the U.S. laws and international agreements governing the export of drugs developed in the U.S. The conclusion will consider the future of drug exports and some possible approaches to the problems.

Background of the Development and Export of Drugs

The modern pharmaceutical industry is a fairly recent development. Until the Twentieth Century, the process of drug innovation and development was a fairly haphazard affair. New drugs were tested instantly upon human patients and few had any beneficial effect. In fact, all too often the new drug hastened the death of the patient. In the mid-Nineteenth Century, researchers started having some success in separating the effective agents from their parent compounds and began to discover why certain agents were effective and others were not. Synthetic drugs were introduced during this time, the most important being anesthetics and painkillers.

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or this is that these countries are at least as sophisticated as the United States with regard to drug regulation and are fully capable of ascertaining the safety and efficacy of new drugs and of enforcing conditions under which these drugs are manufactured and sold. In addition, the 1986 Amendments only allow the export of drugs to these listed countries if the drug s the subject of an investigational new drug exemption and the manufacturer is actively pursuing FDA approval. Consequently, it is presumptuous and even egotistical to argue that authorities in the United States are more qualified to determine which drugs are safe enough to be consumed by Europeans than are European authorities. Current Law and Issues Until 1986, the export provision of the Food, Drug, and Cosmetic Act had remained virtually unchanged since its inception in 1938. This export provision allowed the exportation of drugs to foreign countries if they met the specifications of the foreign purchaser, did not conflict with the laws of the importing nation, bore labels which stated that the drugs were intended for export, and if they were not offered for domestic sale (without complying with U.S. laws). As the years went by, however, amendments and
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Approximate Word count = 4857
Approximate Pages = 19 (250 words per page)