Unapproved drugs could be exported to WTO countries without FDA approval under draft bill.
Executive Summary
UNAPPROVED DRUG EXPORT WITHOUT FDA OKAY WOULD BE ALLOWED under a bill being readied by Rep. Upton (R-Mich.). The bill would repeal FDA export review requirements for unapproved devices and drugs being shipped to World Trade Organization member countries. The "FDA Export Reform and Enhancement Act of 1995" is slated to be introduced the week of March 6. WTO, the international body created to implement the General Agreement on Tariffs & Trade, has 80 members, and membership is pending for 10 additional countries.