Regulatory Focus™ > News Articles > UPDATED: FDA Completes Work on Three User Fee Acts, Sends to Congress

UPDATED: FDA Completes Work on Three User Fee Acts, Sends to Congress

Posted 13 January 2012 | By Alexander Gaffney, RAC 

Right on schedule, the US Food and Drug Administration (FDA) today confirmed that it has finished work on three user fee programs that will be sent to the Congress immediately.

In a blog posting on the FDA Voice blog, FDA Commissioner Margaret Hamburg called the existing User Fee Acts "highly successful" programs that were responsible for "revolutionizing the drug approval process."

Hamburg noted that Department of Health and Human Services Secretary Kathleen Sebelius has signed off on the three user fee acts-the Prescription Drug User Fee Act (PDUFA, the Generic Drugs User Fee Act (GDUFA) and the Biosimilar and Interchangeable Products User Fee (BIPUF)-and sent them to congress for consideration and markup.

The Medical Device User Fee Act negotiations are still ongoing, according to Karen Riley, public affairs specialist at FDA, who noted that negotiators have met 29 times over the proposed user fee act. The House Energy and Commerce Committee is due to hold a hearing on the legislation on 15 February.

The programs supplement FDA's budget by requiring industry to pay fees to FDA in return for product approval deadlines that FDA must try to adhere to. Hamburg said that the programs "offer a net win for consumers and patients, offering more choices and lower-cost products."

PDUFA is set to expire in September, making the prospect of any slowdown in the legislative process a dangerous one for FDA and the pharmaceutical industry alike.

GDUFA is aimed at clearing a massive backlog of Abbreviated New Drug Applications, which are used to approve generic drug products.

BIPUF would also set user fees for so-called biosimilars, which are biologic products that are highly similar to-but not the same as-a Reference-Listed Drug (RLD) biologic product.

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