House lawmakers approved the FDA user fee reauthorization bill, but added a bipartisan amendment aiming to curb abusive drug pricing on pharmaceuticals without generic competition.
The amendment offers a six-month exclusive rights period to generic manufacturers who choose to compete against an off-patent drug that currently has no competition, promisng a six-month approval timeline for the application. Additionally, it gives the company a voucher that would guarantee expedited review of another generic product.
The amendment and the bill both passed unanimously out of the Health subcommittee of the House Energy and Commerce Committee.
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