User Fee Bill Clears Senate Committee With Importation, Orphan Drug Amendments

Highlighting the much-less-bipartisan atmosphere than the House, ranking member Burr votes against the package; US FDA’s advice to generic applicants could be contentious issue in reconciling the legislation between the two chambers.

United States Capitol on 50 Dollars bill USA money banknote — • Source: Shutterstock

The US Food and Drug administration’s user fee programs took another step closer to renewal on 15 June, with legislation clearing the Senate’s Health, Education, Labor and Pensions Committee – but the tenor of the markup suggests the final steps to reauthorization could be increasingly less smooth.

The HELP committee’s vote on the bill had already been pushed back by a week while members worked to resolve...