FDA Export Reform

Pursuant to a congressional request, GAO reviewed proposed drug export legislation that would allow the export of drugs not approved by the Food and Drug Administration (FDA), focusing on the: (1) criteria that Congress could use to identify whether countries have adequate drug regulatory systems; and (2) implications of applying those criteria to other countries. GAO noted that: (1) the World Health Organization's (WHO) existing information system is adequate to identify criteria to assess countries' pharmaceutical regulatory systems; (2) countries that meet the export criteria should have adequate drug laws and regulatory bodies that oversee pharmaceutical activities, a drug registry, and drug quality assurance and adverse drug reaction (ADR) systems; (3) most of the countries with the largest economies meet the export criteria, but many do not have formal ADR systems; (4) most countries rely on the exporting country's regulatory authority to certify an exported drug's registration and sales authorization because they lack a comprehensive quality assurance system; (5) since non-FDA approved drugs are not freely marketed in the United States, non-tier I importing countries will have to rely on their own or other countries' quality assurance systems; and (6) WHO will complete 2 additional studies that will provide further information on countries' drug regulatory systems and identify essential evaluation criteria.