With Senator Kennedy on their side, the U.S. drug companies are making their move on the Senate floor soon to pass S. 1848. This legislation would allow drug companies to sell to foreign countries pharmaceuticals which are not approved by the U.S. Food and Drug Administration (FDA).
For years the U.S. has stood alone among nations for the principle that drugs that are not safe for Americans should not be exported to people abroad. Other nations have pursued this double standard.
This legislation received Senator Kennedy’s balance-shifting support earlier this year in spite of the fact that the FDA admitted in Congressional testimony that the provision in the bill against re-exportation from an approved foreign nation — say England or France -is unenforceable. Once the drugs leave U.S. ports, there is no feasible way to prevent transshipment from France to African or Asian nations.
A large number of international health and consumer groups have asked Congress not to pass S. 1848. They claim that efforts underway in Western Europe to enact legislation to bring those nations up to the present U.S. standard will be destroyed. Instead S. 1848 would begin a race to the bottom among drug exporters.
With all its limitations, the FDA is the toughest safety agency regarding approval of drugs in the world. Repeatedly, France and England have been embarrassed by drugs which they approved but then had to be withdrawn from the marketplace because of dangers to patients.
Dr. Philip Lee, a leading authority on international drug marketing practices, wants to close the loophole that presently allows exports of unapproved antibiotics to other countries. He does not want to see a “Made in U.S.A.” label attached to drugs that could seriously harm innocent people in third world countries that have no realistic safety clearance process.
Nonetheless, the Reagan government is pushing with the drug companies for S. 1848. Every argument the Administration has advanced has been carefully rebutted in Congressional testimony. For example, the Reaganites claim the bill is necessary to permit the export of tropical disease drugs. The Office of Science and Technology, in a recent report on the status of biomedical research and related technology for tropical diseases, did not mention the drug approval process as even a minor obstacle to the development of these drugs, but cited the poverty of the would-be buyers of those drugs as the major inhibitor of American companies in developing the drugs.
There have been some major disasters in third world countries, including ones affecting children, due to the export of harmful, poorly tested drugs from western European countries. Consumer groups in the U.S. do not want any such calamities occurring with a “Made in U.S.A.” label. They want to see S. 1848 stopped in the House of Representatives if not in the Senate.
Stalwart Senators Howard Metzenbaum and William Proxmire have pledged to fight the legislation on the Senate floor. They need the support of all Americans who believe that one safety standard, not a double safety standard, should be the American way here and abroad.