H.R. 3988 (112th): Generic Drug and Biosimilar User Fee Act of 2012

Introduced:
Feb 08, 2012 (112th Congress, 2011–2013)
Status:
Died (Referred to Committee)
Sponsor
Tim Murphy
Representative for Pennsylvania's 18th congressional district
Party
Republican
Text
Read Text »
Last Updated
Feb 08, 2012
Length
88 pages
Related Bills
S. 3187 (Related)
Food and Drug Administration Safety and Innovation Act

Signed by the President
Jul 09, 2012

H.R. 5651 (Related)
Food and Drug Administration Reform Act of 2012

Passed House
Last Action: May 30, 2012

 
Status

This bill was introduced on February 8, 2012, in a previous session of Congress, but was not enacted.

Progress
Introduced Feb 08, 2012
Referred to Committee Feb 08, 2012
 
Full Title

To amend the Federal Food, Drug, and Cosmetic Act to establish user-fee programs for generic drugs and biosimilars.

Summary

No summaries available.

Cosponsors
4 cosponsors (3D, 1R) (show)
Committees

House Energy and Commerce

Health

The committee chair determines whether a bill will move past the committee stage.

 
Primary Source

THOMAS.gov (The Library of Congress)

GovTrack gets most information from THOMAS, which is updated generally one day after events occur. Activity since the last update may not be reflected here. Data comes via the congress project.

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Citation

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Notes

H.R. stands for House of Representatives bill.

A bill must be passed by both the House and Senate in identical form and then be signed by the president to become law.

The bill’s title was written by its sponsor.

GovTrack’s Bill Summary

We don’t have a summary available yet.

Library of Congress Summary

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.


2/8/2012--Introduced.
Generic Drug and Biosimilar User Fee Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS), beginning FY2013, to assess and collect the following fees related to generic drugs:
(1) a one-time backlog fee for abbreviated new drug applications pending on October 1, 2012;
(2) a drug master file fee;
(3) an abbreviated new drug application and prior approval supplement filing fee, as well as an additional fee for active pharmaceutical ingredient information not included by reference to Type II active pharmaceutical ingredient drug master file; and
(4) a generic drug facility fee and active pharmaceutical ingredient facility fee.
Provides that submission of an application for a positron emission tomography drug or active pharmaceutical ingredient for a positron emission tomography drug shall not require the payment of any fee.
Sets forth provisions relating to fee amounts and due dates.
Terminates the above provisions on October 1, 2017.
Requires the Secretary to report to Congress on the progress of the Food and Drug Administration (FDA) in achieving specified safety, access, and transparency goals with respect to generic drugs.
Biosimilar User Fee Act of 2012 - Directs the Secretary, beginning FY2013, to assess and collect the following fees related to biosimilar biological products:
(1) biosimilar program development fees, encompassing an initial biosimilar biological development fee, an annual biosimilar biological product development fee, and a reactivation fee;
(2) a biosimilar biological product application and supplement fee;
(3) a biosimilar biological product establishment fee; and
(4) a biosimilar biological product fee.
Waives the above fees for the first biosimilar biological product application of a small business.
Terminates the above provisions on October 1, 2017.
Requires the Secretary to report to Congress on the progress of the Food and Drug Administration (FDA) in achieving specified goals with respect to biosimilar biological products.

House Republican Conference Summary

The summary below was written by the House Republican Conference, which is the caucus of Republicans in the House of Representatives.


No summary available.

House Democratic Caucus Summary

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