About | HeinOnline Law Journal Library | HeinOnline Law Journal Library | HeinOnline
LOG IN
LOG IN

HEHS-96-60R 1 (1995-12-21)

handle is hein.gao/gaobaclao0001 and id is 1 raw text is: GAO United States General Accounting Office Washington, D.C. 20548 Health, Education and Human Services Division B-266229 December 21, 1995 The Honorable Nancy Landon Kassebaum Chairman, Committee on Labor and Human Resources United States Senate Dear Madam Chairman: Under current law, U.S. pharmaceutical manufacturers must obtain approval from the Food and Drug Administration (FDA) to export drugs for marketing that are not approved for sale in the United States. Further, unapproved drugs may only be exported from the United States to 21 designated countries if these countries have approved the drugs for sale. Many in Congress are concerned that such restrictions on exports cost American jobs, create an incentive for firms to build new manufacturing facilities overseas, and deny American- manufactured drugs to countries whose own regulatory systems have approved them. 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 'The bill also includes provisions for exporting unapproved animal drugs, biological products, and medical devices. This letter considers only drugs. 2The tier I countries listed in S. 593 are Australia, Canada, Israel, Japan, New Zealand, Switzerland, and any country in the European Union or within the European Economic Area (including, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, GAO/HEHS-96-60R FDA Export Reform e 95+q

What Is HeinOnline?

HeinOnline is a subscription-based resource containing thousands of academic and legal journals from inception; complete coverage of government documents such as U.S. Statutes at Large, U.S. Code, Federal Register, Code of Federal Regulations, U.S. Reports, and much more. Documents are image-based, fully searchable PDFs with the authority of print combined with the accessibility of a user-friendly and powerful database. For more information, request a quote or trial for your organization below.



Contact us for annual subscription options:

Contact Us

Already a HeinOnline Subscriber?

Log In

profiles profiles most