S. 622: Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013

S. 622

Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013

Sponsor
Sen. Tom Harkin

Date
June 3, 2013 (113th Congress, 1st Session)

Staff Contact
Communications

Floor Situation

On Monday, June 3, 2013, the House is scheduled to consider S. 622, the Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013,under a suspension of the rules. The bill was introduced on March 20, 2013 by Sen. Tom Harkin (D-IA), referred to the Senate Committee on Health, Education, Labor, and Pensions, and passed the Senate on May 8, 2013 by unanimous consent. 

Bill Summary

S. 622 reauthorizes two programs providing for the collection and spending of fees by the Food and Drug Administration (FDA) in order to expedite the review and approval of drugs for use in animals.  Under the programs, FDA may assess different types of fees, the amounts, proportion, and annual adjustments of which are fixed in the bill and have been negotiated between the FDA and stakeholders, as required by current law.  The fees collected may not be spent or obligated without future appropriation.  This authority will expire October 1, 2018.

Also included in the legislation, as in previous authorizations, are provisions requiring annual performance and financial reports from the Secretary of Health and Human Services concerning the progress of achieving the program’s statutory goals and the use of the fees.  Further, the law establishes a process of consultation with stakeholders for proposing changes in future reauthorization bills.

Background

In 2003, Congress first enacted the Animal Drug User Fee Act (ADUFA) (P.L. 108-130, passed the House by voice vote), which established a user fee program to help improve the Food and Drug Administration’s (FDA) review of new animal drugs.  Under the program, FDA collected fees to expedite the approval process, reduce the application backlog, and improve communication with drug sponsors.[1]  The program was reauthorized for an additional five years in 2008 (P.L. 110-316, passed by voice vote in the House).

As part of the reauthorization of ADUFA in 2008, Congress also enacted a new program to help improve FDA review of generic drugs, called the Animal Generic Drug User Fee Act (AGDUFA).[2]  AGDUFA helps to ensure that customers have access to safe, lower cost alternatives to brand name animal drugs.[3]

Both of these programs expire on October 1, 2013.  S. 622 reauthorizes these programs for an additional five years and is the result of negotiation between the FDA and stakeholders, as stipulated in the statute.  According to testimony from the Director of the Center for Veterinary Medicine at the FDA, “[given] the current success of the program, FDA and industry agreed that only minor refinements were necessary.”[4]


[2] Id.

[4] Animal Drug User Fee Agreements: Advancing Animal Health for the Public Health: Hearing on S. 622 Before the Senate Committee on Health, Education, Labor, and Pensions, 113th Cong. 5 (2013) (Statement of Bernadette M. Dunham, D.V.M., Ph.D., Dir. of Center for Veterinary Services, FDA)

Cost

“CBO estimates that implementing S. 622 would reduce discretionary outlays, on net, by $7 million over the 2014-2018 period, assuming appropriation actions consistent with the bill.”[1]