HR 5651 · 112th Congress · Health

Food and Drug Administration Reform Act of 2012

Introduced 2012-05-09· Sponsored by Rep. Upton, Fred [R-MI-6]· House

Bill Progress

Introduced
Committee
House Vote
4
Senate
5
Enacted
Latest: Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 420.(2012-06-04)

Recorded Votes

PassedHouse · 2012-05-30
Roll #294
Yea 387Nay 5
Democrats
168 Yea·1 Nay
Republicans
219 Yea·4 Nay
PassedHouse · 2012-05-30
Roll #294
Yea 387Nay 5
Democrats
168 Yea·1 Nay
Republicans
219 Yea·4 Nay

How Did Your Rep Vote?

Enter a ZIP code or representative's name

Plain Language Summary

[AI summary unavailable — showing source text] Food and Drug Administration Reform Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to reauthorize and establish new Food and Drug Administration (FDA) prescription drug user-fee programs and revises requirements relating to: (1) prescription, pediatric, and generic drugs; (2) medical devices; (3) biosimilar biological products; (4) new infectious disease drugs; and (5) drug manufacturer reporting. Prescription Drug User Fee Amendments of 2012 - Extends through FY2017 the authority of the Secretary of Health and Human Services (HHS) to assess and collect prescription drug fees to support the FDA drug development and human drug application review process. Medical Device User Fee Amendments of 2012 - Extends through FY2017 the authority of the Secretary to assess and use fees for expediting the review process for medical device applications and for assuring the safety and effectiveness of such devices. Generic Drug User Fee Amendments of 2012 - Directs the Secretary to assess and collect human generic drug user fees through FY2017, including a fee for drug applications pending on October 1, 2012, a drug master file fee, a generic drug facility fee, and an active pharmac…

Summarized by Claude AI · Non-partisan · For informational purposes only

CBO Cost Estimate

Congressional Budget Office

H.R. 5651, Food and Drug Administration Reform Act of 2012

May 24, 2012

As ordered reported by the House Committee on Energy and Commerce on May 10, 2012

Full CBO report ↗

Amendment in the Nature of a Substitute to H.R. 5651, the Food and Drug Administration Reform Act of 2012

May 29, 2012

Statutory Pay-As-You-Go Effects for an Amendment in the Nature of a Substitute to H.R. 5651, as posted on the Web site of the Committee on Energy and Commerce on May 25, 2012

Full CBO report ↗

Official non-partisan budget analysis by the Congressional Budget Office

Cosponsors (5)

3 Democrats2 Republicans