Government Healthcare Policy, Business and Technology

House committee adds pharma 'bad actor' provision to FDA user fee bill

Modern Healthcare: A group of House lawmakers on Thursday approved the FDA user fee reauthorization bill and added a bipartisan amendment aiming to curb abusive drug pricing on pharmaceuticals without generic competition.

The amendment and the bill, both passed unanimously out of the Health subcommittee of the House Energy and Commerce Committee. The Senate version did not include that same drug pricing provision.

Rep. Kurt Schrader, D-Ore., joined forces with Rep. Gus Bilirakis, R-Fla., to write the amendment, which offers a six-month exclusive rights period generic manufacturers who choose to compete against an off-patent drug that currently has no competition. Currently, that six month exclusivity is only available to a first entrant.

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