Generic

House Adds Drug Pricing Provision to FDA User Fee Bill

May 19, 2017

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.

Read the Modern Health coverage