Lawmakers Reach Deal on FDA Bill That Would Add Some Filing Reqs for Drug Importers

June 19, 2012 by Tim Warren|Congress

A group of lawmakers said June 18 they reached a deal on 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."

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

Importers may also be allowed to participate in trusted partnership programs that would allow for expedited treatment of drug shipments based on a risk assessment of the importer and the drugs being sent.

The House is expected to vote on the measure next week, according to a press report. The Senate must still pass the bill, as amended. Senate Health, Education, Labor and Pensions Committee Chairman Tom Harkin (D-Iowa), Ranking Member Mike Enzi (R-Wyo.), House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) and Ranking Member Henry Waxman (D-Calif.) announced the compromise (here). The current authorization ends Sept. 30. Harkin said he hopes the Senate and House will pass the bill and send it to the President soon.

(See ITT's Online Archive 11101817 for summary of a hearing last year with FDA and GAO officials pushing for increased supply chain security).