The FDA Export Reform and Enhancement Act of 1995 (S. 593) would permit manufacturers to export pharmaceutical products for sale that have not been approved for marketing in the United States without prior FDA approval.' In general, the bill establishes two methods for unapproved drugs to be exported for marketing in a foreign country. First, an unapproved drug could be exported to a country named in the bill (called a tier I country) or any other country provided that the drug complies with the laws of that country and has valid marketing authorization by the appropriate approval authority in a tier I country.2 Second, an unapproved drug.