Congressional Legislation
This summary has been edited for lengthTitle I: Fees Relating to Drugs - Prescription Drug User Fee Amendments of 2012 - (Sec. 103) Extends through FY2017 the authority of the Secretary of Health and Human Services (HHS) to assess and collect human drug application and supplement fees, prescription drug establishment fees, and prescription drug product fees to support the FDA drug development process and the process for the review of human drug applications. Increases for FY2013-FY2017 the lev
Bill # H.R.5651

Original Sponsor:
Fred Upton (R-MI 6th)

Cosponsor Total: 2
(last sponsor added 05/09/2012)
  1 Republicans
  1 Democrats
About This Legislation:
This summary has been edited for length
Title I: Fees Relating to Drugs - Prescription Drug User Fee Amendments of 2012 - (Sec. 103) Extends through FY2017 the authority of the Secretary of Health and Human Services (HHS) to assess and collect human drug application and supplement fees, prescription drug establishment fees, and prescription drug product fees to support the FDA drug development process and the process for the review of human drug applications. Increases for FY2013-FY2017 the level of required prescription drug user fee revenues. Provides for an inflation adjustment and a workload adjustment for FY2013 and subsequent fiscal years for the required level of user fee revenue amounts.
Title II: Medical Device User Fee Amendments of 2012 - Medical Device User Fee Amendments of 2012 - (Sec. 203) Extends through FY2017 the authority of the Secretary to assess and collect fees for medical device applications and submissions. Increases for FY2013-FY2017 the level of required medical device user fee revenues. Provides for an inflation adjustment to such revenues in FY2014 and each subsequent fiscal year. Authorizes the Secretary to grant a waiver or reduction of medical device user fees in the interest of public health.
Title III: Fees Relating to Generic Drugs - Generic Drug Use Fee Amendments of 2012 - (Sec. 302) Directs the Secretary, beginning in 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 certain active pharmaceutical ingredient information; 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 such a drug shall not require the payment of any fee. Terminates such authority on October 1, 2017.
Title IV: Fees Relating to Biosimilar Biological Products - Biosimilar User Fee Act of 2012 - (Sec. 402) 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 such fees for the first biosimilar biological product application of a small business. Terminates such authority on October 1, 2017.
Title V: Reauthorization of Best Pharmaceuticals for Children Act and Pediatric Research Equity Act - (Sec. 501) Makes permanent the: (1) the Best Pharmaceuticals for Children Act (BPCA) granting extended market exclusivity for new and already-marketed drugs for the pediatric population, and (2) the Pediatric Research Equity Act of 2003 (PREA) relating to research into pediatric uses for drugs and biological products.
Title VI: Food and Drug Administration Administrative Reforms - (Sec. 601) Requires the Secretary to publish in the Federal Register at least 30 days' advance notice of the Secretary's intent to issue a draft guidance document that: (1) sets forth initial interpretations of a statute or regulation, (2) sets forth changes in interpretation or policy that are of more than a minor nature, (3) includes complex scientific issues, or (4) covers highly controversial issues.
Title VII: Medical Device Regulatory Improvements - Subtitle A: Premarket Predictability - (Sec. 701) Prohibits the Secretary from disapproving an application for approval of a medical device for investigational use on the basis that: (1) the investigation may not support a substantial equivalence or de ...
Detailed, up-to-date bill status information on H.R.5651.