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TODAY’S TOPIC: The Morality of Selling America’s Unapproved Drugs Abroad

September 24, 1985

WASHINGTON (AP) _ President Reagan’s proposal to allow the export of drugs not approved for use in this country promises to reopen a heated debate over the morality of selling foreign consumers medicines that Americans don’t trust enough to use themselves.

Opponents say the proposal would make guinea pigs of sick people overseas. Proponents say the United States shouldn’t refuse to allow another country to buy drugs it believes will help its citizens.

The president proposed Monday that Congress repeal a ban on exports of pharmaceutical products that have not been determined to be safe and effective by the Food and Drug Administration.

The proposal is part of a refurbished administration trade policy that focuses on opening foreign markets to American goods rather than protecting domestic industries.

A spokeswoman for Sen. Orrin G. Hatch, R-Utah, who has championed the cause of drug exports in Congress, said after Reagan’s speech that Hatch would introduce legislation early next week implementing the president’s plan. Similar bills by Hatch have failed in the past.

The legislation will face determined opposition from those who contend it is immoral.

″The United States of America has the finest and most stringent drug approval process in the world,″ the American Public Health Association said in opposing a similar Hatch bill last year. ″We must not fail to extend the same protections we provide Americans to international consumers. To do otherwise would be morally wrong and would be bad international policy.″

The export ban has been in federal law since 1938. Repeated attempts to repeal it have been unsuccessful, although Hatch and other opponents contend it got into the law through a drafting error, not deliberate policy.

The ban forbids exports of new drugs unless they have been approved by the FDA, even if they are legal in the receiving country.

Hatch, chairman of the Senate Labor and Human Resources Committee, says the restriction is unique in the world. The United Nations has adopted a policy of leaving such restrictions up to the importing nation, not the exporter, he says. The ban also is unique to drugs; even in the case of hazardous chemicals, he says, the importing nation makes the decision.

Proponents say the U.S. policy is inappropriately paternalistic. FDA Commissioner Frank D. Young says the United States should respect the right of sovereign nations to choose what medicines should be made available within their borders.

″Each sovereign government has the chief responsibility for determining the types of drugs that can be imported from abroad,″ Young said earlier this year.

Irene Forde-Howard, a spokeswoman for Hatch, said that while some details of Hatch’s new bill remain unresolved, it will be similar to a bill last year that the senator said would avoid abuses feared by opponents.

Hatch’s 1984 bill, endorsed by the FDA and the pharmaceutical industry, would ease restrictions on exports by recognizing drug approvals of other countries that are determined by FDA to have adequate drug testing procedures.

Such legislation is endorsed by the World Health Organization, among others. But it is bitterly opposed by the American Public Health Association, the Associated Pharacologists and Toxicologists, the Consumer Federation of America and consumer groups in Australia, Belgium, Japan and India.

They argue that such exports turn the rest of the world’s population into human guinea pigs for drug experimentation, while Americans remain protected by the strict approval requirements set by FDA.

And the interest of drug manufacturers in exporting such drugs, they argue, is in the profits to be made, not the diseases to be cured.

The American Public Health Association, in its critique of Hatch’s bill last year, said the measure ″could result in the export of possibly dangerous drugs as well as those withdrawn from sales or from the application process because of serious problems.″

Dr. Sidney M. Wolfe of the Public Citizen Health Research Group testified before Congress earlier this year that repeal of the ban ″establishes a double standard which violates our basic belief that the health and safety of international consumers is no less important than that of American consumers.″

″To the extent that U.S. drug approval takes longer because our laws impose higher standards, delays in approval must be accepted,″ said Wolfe. ″... The enactment of a double standard of protection - one rule applicable to us, and one applicable to everyone else - is clearly not the proper response.″

Wolfe predicted major problems if the bill were approved, arguing that despite Hatch’s restrictions, drug companies would rush to dump their more dangerous drugs in Third World countries that do not have the scientific capability to properly evaluate the hazards.

He said it also would run counter to an international trend toward tightening controls over the export of drugs and other hazardous products. Such actions have been taken or are being considered by the European Parliament, the Organization of American States, the United Nations and other international groups, Wolfe said.