Regulatory Focus™ > News Articles > Group Calls for Changes to User Fee Bill After Transparency Concerns Emerge

Group Calls for Changes to User Fee Bill After Transparency Concerns Emerge

Posted 04 June 2012 | By Alexander Gaffney, RAC 

A group of 20 public interest organizations has written the US Congress to express their displeasure with a measure which would purportedly allow the US Food and Drug Administration (FDA) to hide health and safety inspection information from the public.

The group is most concerned about Section 812 of the FDA Reform Act (FDARA), which they say "allows 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."

The text of Section 812 of FDARA reads, in part: "Except pursuant to an order of a court of the United States, the Secretary shall not be required to disclose under section 552 of title 5, United States Code, or any other provision of law, 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."

FDA would also be enabled by Section 812 to enter into Memoranda of Understanding to exchange information with state and foreign governments so long as the parties have demonstrated an ability to "protect trade secret information from disclosure."

In its letter, the group notes while Congress' intent is to promote the exchange of drug inspection data, the agency already possesses the authority and statutory limitations against disclosure that Congress wishes to endow it with.

"FDA does not need this authority because the Freedom of Information Act (FOIA) already provides exemptions to protect against the release of many law enforcement records, confidential or commercial information, and trade secrets," noted the group.

The organizations, which include Public Citizen, the Project on Government Oversight, OMB Watch, and Citizens for Responsibility and Ethics in Washington, calls for Section 812 to be "narrowly tailored to avoid unintentionally or unnecessarily increasing secrecy at the FDA," if not outright eliminated.

The group is also concerned the legislative language of Section 812 is written broadly enough that it could potentially include information which is currently lawful and required to be disclosed, such as potential health and safety risks.

While the groups had pressed the Congress to make changes to the legislation before the final vote, it does not appear to have been changed in the House's approved final language. Any potential changes would now need to come out of a conference committee set to negotiate out the differences between the House's FDARA and the Senate's FDA Safety and Innovation Act.


Read more:

Letter to Chairman Fred Upton and Ranking Member Henry Waxman

Public Citizen - Legislation Could Block Public Access to Drug Safety Information

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