Senate Passes FDA Bill That Would Add Some Filing Reqs for Drug Importers

The Senate on June 26 passed the Food and Drug Administration Safety and Innovation Act, (S-3187), which reauthorizes for five years Food and Drug Administration (FDA) user fees for FDA drug review processes. The legislation would direct the Department of Health and Human Services (DHHS) to work with CBP to develop "regulations to establish good importer practices that specify the measures an importer shall take to ensure imported drugs are in compliance with the requirements of this Act." The legislation, which was approved by the Senate by a vote of 92 to 4, now goes to President Obama for his signature.

Text of the legislation is (here).

Among other things, commercial drug importers will be required to register with the DHHS. They may also have to submit information:

• demonstrating the regulatory status of the drug, such as the new drug application, abbreviated new drug application, or investigational new drug or drug master file number;
• facility information, such as proof of registration and the unique facility identifier;
• indication of compliance with current good manufacturing practice, testing results, certifications relating to satisfactory inspections, and compliance with the country of export regulations; and
• any other information deemed necessary and appropriate by the Secretary of DHHS to assess compliance of the article being offered for import

(See ITT's Online Archives 12061925 for summary of a deal reached by lawmakers on the legislation).