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Titles Actions Overview All Actions Cosponsors Committees Related Bills Subjects Latest Summary All Summaries

Titles (4)

Short Titles

Short Titles - House of Representatives

Short Titles as Introduced

Generic Drug and Biosimilar User Fee Act of 2012

Short Titles as Introduced for portions of this bill
  • Biosimilar User Fee Act of 2012
  • Generic Drug User Fee Amendments of 2012

Official Titles

Official Titles - House of Representatives

Official Title as Introduced

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


Actions Overview (1)

Date
02/08/2012Introduced in House

All Actions (3)

Date
02/10/2012Referred to the Subcommittee on Health.
Action By: Committee on Energy and Commerce
02/08/2012Referred to the House Committee on Energy and Commerce.
Action By: House of Representatives
02/08/2012Introduced in House
Action By: House of Representatives

Cosponsors (4)

* = Original cosponsor
CosponsorDate Cosponsored
Rep. Pallone, Frank, Jr. [D-NJ-6]* 02/08/2012
Rep. Pitts, Joseph R. [R-PA-16]* 02/08/2012
Rep. Waxman, Henry A. [D-CA-30]* 02/08/2012
Rep. Dingell, John D. [D-MI-15] 02/21/2012

Committees (1)

Committees, subcommittees and links to reports associated with this bill are listed here, as well as the nature and date of committee activity and Congressional report number.

Committee / Subcommittee Date Activity Reports
House Energy and Commerce02/08/2012 Referred to
House Energy and Commerce Subcommittee on Health02/10/2012 Referred to

A related bill may be a companion measure, an identical bill, a procedurally-related measure, or one with text similarities. Bill relationships are identified by the House, the Senate, or CRS, and refer only to same-congress measures.


Latest Summary (1)

There is one summary for H.R.3988. View summaries

Shown Here:
Introduced in House (02/08/2012)

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.