By SUZANNE DERSHOWITZ
Yesterday, POGO and a range of other good government organizations sent a letter to House Energy and Commerce Committee Chairman Rep. Fred Upton (R-MI) and Ranking Member Rep. Henry Waxman (D-CA) opposing a harmful provision of the Food and Drug Administration Reform Act of 2012 (H.R. 5651).
As stated in the letter, Section 812 of the bill would allow the FDA to deny public access to “any information relating to drugs obtained from a Federal, State, or local government agency, or from a foreign government agency, if the agency has requested that the information be kept confidential.” This could have real negative consequences by unnecessarily increasing secrecy at the FDA and restricting the public’s right to know about critical health and safety risks.
The House is scheduled to vote on this legislation today, and POGO is urging Members to remove (or substantially narrow) Section 812 before it’s too late. In the Senate version of the bill (S. 3187), Senator Patrick Leahy (D-VT) offered an amendment aimed at addressing these problems. The Senate unanimously adopted his amendment, which limits the scope to cover information voluntarily provided by foreign governments, requires that requests to keep information confidential be in writing, and specifies a time frame after which the information will no longer be considered confidential.
As we wrote in the letter, we understand that the intent of the provision is to promote information-sharing between foreign governments and the FDA. The language in H.R. 5651, however, is misguided. The Freedom of Information Act (FOIA) already provides exemptions to safeguard against the release of these kinds of protected records. Section 812 goes beyond its intent—it is written so broadly that it could prevent the release of information that the FDA is currently required to disclose.
What’s at stake here is the public’s access to information about how the FDA conducts the people’s business. In a bid for government openness and accountability, concerned organizations and individuals are urging Congress to strike down this provision.
Suzanne Dershowitz is POGO's public policy fellow.
Photo via GenBug.