Inactive Ingredient Disclosure Expansion In House User Fee Bill Poised For Changes

Republicans share brand industry worry about disclosure of confidential commercial information, suggesting changes may be possible during the upcoming full committee bill mark-up.

Fred Upton discusses House user fee bill
Rep. Fred Upton, R-MI, debates the inactive ingredient provision in the House user fee reauthorization bill. • Source: Screenshot

Generic sponsors may see the amount of reference product inactive ingredient detail they would receive from the FDA eroded when the House Energy and Commerce Committee continues its consideration of user fee reauthorization legislation.

Several Republican members of the committee’s Health Subcommittee raised concerns about the provision in the user fee package, saying...

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