Hearing on Generic, Biosimilar User Fee Acts Scheduled for 9 February

The House Energy and Commerce Committee is scheduled to hear testimony from high ranking US Food and Drug Administration and biopharmaceutical industry officials on 9 February.

The hearing, Review of the Proposed Generic Drug and Biosimilars User Fees and Further Examination of Drug Shortages, will feature Center for Drug Evaluation and Research Director Dr. Janet Woodcock, Mylan, Inc President Heather Bresch, Generic Pharmaceutical Association Vice President for Regulatory Sciences David Gaugh and St. Jude Children's Research Hospital Chief Pharmaceutical Officer Bill Greene.

The committee will hear testimony regarding two pieces of user fee legislation - the Generic Drug User Fee Act (GDUFA) and Biosimilar and Interchangeable Products User Fee Act.

The hearing will be streamed online starting at 10:00 AM EST on 9 February.