House of Representatives To Grill FDA on FDASIA

House of Representatives To Grill FDA on FDASIA

November 14th, 2013 // 1:40 pm @

A year has passed since Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA) act. Now, legislators are wondering how the law is doing, and an upcoming hearing this week answer some questions that Congress has.

FDASIA was passed in 2012, and has provisions that include both user fee programs and reforms.

First, FDASIA reauthorized two types of user fee programs – the Prescription Drug User Fee Act, or PDUFA, and the Medical Device User Fee Act, or MDUFA. PDUFA and MDUFA have higher fees compared to what they charged before FDASIA. MDUFA’s fees are a good deal higher, and Congress will be interested to see if having more money from industry is helping to boost FDA performance.

FDASIA also created new user fee programs. One is the Biosimilar User Fee Act, and the other is the Generic Drug User Fee act. BsUFA is a small program because no biosimilars have yet been approved. GDUFA is much broader, and is supposed to cut down on the backlog of generic drug applications at FDA.It also is supposed to give FDA the money it needs to do more cGMP inspections overseas at generic plants.

FDASIA also has a lot of changes in regulations that are supposed to solve many programs. Title X has new rules that are supposed to help cut drug shortages. Title IX is supposed to create the new Breakthrough Product Designation, which had its first approval recently. Title VIII has the Generating Antibiotic Incentives Now Act, which is supposed to encourage the development of new antibiotics.

The law also contains reforms related to pediatric testing, medical device regulations and also the drug supply chain.

During the upcoming hearing, there may be some tension. Participants from FDA include Janet Woodcock, director of CDER, as well as Jeff Shuren, director of CDRH. Shuren has gotten a cold reception from Congress before, as some representatives say CDRH is approving devices too slowly. Woodcock my get tough questions on if FDA is doing enough to stop drug shrtages.

Congress has not yet released sequestered user fees to FDA, which is shorting the agency millions of dollars, and FDA also has had its budget slashed recently. So, there could be some fireworks in this FDASIA hearing, which is set for November 15 by the House Energy and Commerce Committee.


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