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HR 3988 112th Congress House Health Administrative law and regulatory procedures Administrative remedies Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug therapy Food and Drug Administration (FDA) Government employee pay, benefits, personnel management Government information and archives Government studies and investigations Health care costs and insurance Health care coverage and access Health information and medical records Health programs administration and funding Prescription drugs User charges and fees

Generic Drug and Biosimilar User Fee Act of 2012

Introduced: February 8, 2012 See on congress.gov
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 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Feb 10, 2012
Referred to the Subcommittee on Health.
Feb 8, 2012
Referred to the House Committee on Energy and Commerce.
Feb 8, 2012
Introduced in House
 Plain-English summary Congressional Research Service

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.

What's happening now February 10, 2012

Referred to the Subcommittee on Health.

 Committees of jurisdiction 2
 Cosponsors 1
All 1 Democratic 1