National Freedom of Information Coalition
Protecting Your Right to Open Government

Senate approves Leahy amendment preserving FOIA for FDA

This morning, the Senate approved an amendment <> from Senator Leahy that preserves FOIA in the FDA Safety and Innovation Act. The original language in the S.3187, Section 708 would have allowed the FDA to deny the public access to information relating to drugs obtained from a federal, state, local, or foreign government agency, if the agency has requested that the information be kept confidential. Senator Leahy's amendment allows the FDA to obtain and protect drug inspection and investigation information from foreign governments under clear guidelines and with delimited protection time.
The original language was opposed in a letter <> by the openness and accountability community. Thanks to the hard work of Senator Leahy and his staff, and the collaboration of the HELP Committee leadership, the request from FDA for a carte blanche to withhold information from the public and Congress was denied. At the same time, the legitimate concerns regarding foreign governments were appropriately addressed.

Senator Leahy's response is below.

Statement Of Senator Patrick Leahy (D-VT),
Chairman, Senate Committee On The Judiciary,
On Adoption of FOIA Amendment to The Food and Drug Administration
Safety and Innovation Act
May 24, 2012


MR. PRESIDENT.   I commend the Senate for unanimously adopting my amendment to address Freedom of Information Act (FOIA) concerns with section 708 of the Food and Drug Administration Safety and Innovation Act. I especially thank Senators Harkin and Enzi — the distinguished Chairman and Ranking Member of the HELP Committee — for working with me to protect the American public’s ability to access important health and safety information under FOIA.  
My amendment improves the bill by allowing the Food and Drug Administration (FDA) to obtain important information about drug inspections and drug investigations undertaken by foreign governments, while at the same time ensuring that the American public has access to information about potential health and safety dangers.  Specifically, the amendment narrows the scope of the FOIA exemption in the original bill to (1) cover only information obtained from foreign government agencies and (2) clarify that the information to be withheld must be voluntarily provided to the FDA pursuant to a written Memorandum of Understanding.   The amendment also preserves the right of the Congress to obtain this information.  Lastly, the amendment places a three-year time limit for withholding information pursuant to the exemption, unless a different time period is specified by the foreign government agency — so that the information will not automatically be shielded from the public indefinitely.
For more than four decades, the Freedom of Information Act has been an indispensible tool for the public to obtain Government information.  This law carefully balances the need for the Government to keep some information confidential, with the need to ensure free flow of information in our Democratic society. I am pleased that by unanimously adopting my amendment, the Senate has worked in a bipartisan manner to ensure that this careful balance is maintained regarding FDA drug inspections and investigations.

I thank the many open government and consumer groups — including and Public Citizen — that supported this amendment.  Again, I also thank and congratulate the lead sponsors of this bill on the passage of this important legislation.