Sen. Orrin G. Hatch (R-Utah) yesterday introduced a new version of a bill to permit the export of U.S.-manufactured drugs that have been approved in certain other industrial countries, but not approved by the Food and Drug Administration for sale in this country.
Hatch's bill, a high priority with the Reagan administration and the U.S. pharmaceutical industry, has been altered in hopes of overcoming the opposition to the initial version, which never got out of Senate committee last year.
In a statement yesterday, Hatch said the bill would permit increased drug production and export from this country without endangering the health of patients in foreign countries. "It would save American jobs, prevent the export of American biotechnology, and decrease our trading deficit . . ., " Hatch said.
A critic of Hatch's original bill, Sidney M. Wolfe, director of the Health Research Group, said the new version appears "just as repugnant. A drug approved for use in the U.S. has met the highest standards of safety and efficacy in the world," said Wolfe.
To permit the export of drugs that cannot meet U.S. standards is "a huge step backwards" in consumer protection, Wolfe said.
Hatch's new bill sets up a three-tier approach for approving export of American-manufactured drugs that have not cleared the FDA. Such drugs first would have to be approved by authorities in one of 14 industrialized nations whose governments have sophisticated drug testing programs, an aide to Hatch said. Once cleared, the drugs could only be shipped to countries certified by the secretary of Health and Human Services as having adequate regulatory procedures for assuring proper labeling of the imported drugs.
An aide said that most Third World nations would not fall into this category, although it wasn't immediately clear how much latitude HHS would have on that issue. The major exception would be drugs for treating tropical illnesses, which could be shipped to the Third World if cleared in one of the 14 countries.