Senate Votes to Let Firms Export Drugs Not Yet Approved as Safe

The Senate voted Wednesday to allow American drug companies to export medicines not yet approved as safe and effective for sale in this country.

The bill, which would repeal a longstanding ban on the export of most prescription drugs not yet approved by the Food and Drug Administration, was passed on a 91-7 vote and sent to the House.

Sen. Orrin G. Hatch (R-Utah), the bill’s principal sponsor, hailed the measure as “landmark legislation” that will help America preserve its lead in biotechnology.

“It’s a real incentive for our companies to remain on our shores and keep the technology here” rather than transferring manufacturing overseas to avoid government regulations, Hatch said.

Embarrassment Feared

But Sen. Howard M. Metzenbaum (D-Ohio) argued that the legislation could ultimately embarrass America by giving U.S. drug companies a “blank check” to sell dangerous or ineffective drugs in Third World nations.

“Do we believe we ought to export drugs throughout the world that say ‘Made in America’ when those same drugs can’t be sold in the United States?” Metzenbaum said shortly before the Senate voted final passage.

Hatch said he is optimistic that the House will pass a drug export bill this year. But Rip Forbes, an aide to Rep. Henry A. Waxman (D-Los Angeles), said it is likely the House will not have time to vote on a drug export bill before it adjourns this year.

Waxman, who chairs the House Energy and Commerce health subcommittee, called the Senate bill “immoral foreign policy that hurts our country.”

Drugs Not Yet Approved

The bill allows drug companies to sell medicines not yet approved by the FDA to 15 so-called first-tier nations that have already found these medications to be safe and effective. Those countries have testing and regulatory agencies equivalent to the FDA.

The countries listed in the group are: Australia, Austria, Belgium, Canada, Denmark, West Germany, Finland, France, Japan, the Netherlands, New Zealand, Norway, Sweden, Switzerland and the United Kingdom.

The second-tier countries, not listed in the bill, would include nations that have developed internal mechanisms to detect drug safety problems and to remove unsafe medications from the market.

U.S. companies could sell unapproved drugs to second-tier countries that are approved by one of the first-tier nations and are not banned by the FDA.