Congress Opts to Protect Access to Important Drug and Safety Info in Compromise FDA Bill

House and Senate negotiators on competing Food and Drug Administration (FDA) reauthorization bills have included in the compromise version language championed by Senator Leahy that goes a long way toward protecting public access to important drug and safety information while addressing the FDA’s concern that some foreign agencies need more assurance the information will be kept confidential to encourage information sharing.

As originally drafted the House bill (HR 5651) and the Senate bill (S.3187) included provisions that authorized the FDA to deny the public access under the Freedom of Information Act (FOIA) 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., along with our allies at Public Citizen and other coalition partners joined in urging Congress to strike the provision, or at least tighten it so as to avoid unintentionally or unnecessarily increasing secrecy at the FDA. Senator Leahy's language, which was accepted as an amendment to S.3187, limits the scope of information the FDA can withhold to information voluntarily provided by foreign governments, requires that the request to keep the information confidential be in writing, and, unless otherwise agreed upon, specifies a time frame after which the information will no longer be treated as confidential.

The House passed the compromise bill on June 20. Once it is passed by the Senate, it will be sent to the President to be signed into law.

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