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.
Comparable language remains, though, in Section 812 of H.R. 5651, the Food and Drug Administration Reform Act of 2012. Stay tuned.