3.0.0 2516 2022-02-03T05:59:20Z 2022-05-20T16:27:20Z Senate S S 2012-05-07 112 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Reported original measure 2012-05-07T19:28:41Z Generic Drug and Biosimilar User Fee Act of 2012 112 3988 HR 2012-02-10 Referred to the Subcommittee on Health. Related bill CRS Prescription Drug Labeling Promotion Act of 2012 112 4087 HR 2012-02-24 Referred to the House Committee on Energy and Commerce. Related bill CRS To amend chapter V of the Federal Food, Drug, and Cosmetic Act to expedite the development and review of breakthrough therapies. 112 5334 HR 2012-05-11 Referred to the Subcommittee on Health. Related bill CRS Food and Drug Administration Reform Act of 2012 112 5651 HR 2012-06-04 Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 420. Related bill CRS Advancing Breakthrough Therapies for Patients Act of 2012 112 2236 S 2012-03-26 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS Better Pharmaceuticals and Devices for Children Act of 2012 112 2289 S 2012-04-17 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS Food and Drug Administration Safety and Innovation Act 112 3187 S 2012-07-09 Became Public Law No: 112-144. Related bill CRS Related bill House 2012-05-07 Senate Placed on Senate Legislative Calendar under General Orders. Calendar No. 389. Calendars 2012-05-07 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Original measure reported to Senate by Senator Harkin. Without written report. Committee 2012-05-07 Committee on Health, Education, Labor, and Pensions. Original measure reported to Senate by Senator Harkin. Without written report. Committee 14000 9 Library of Congress sshr00 Health, Education, Labor, and Pensions Committee 2012-05-07 Introduced in Senate IntroReferral 10000 9 Library of Congress H000206 Sen. Harkin, Tom [D-IA] THOMAS HARKIN D IA RICHARD N Health Administrative law and regulatory procedures Administrative remedies Advisory bodies Cancer Child health Congressional oversight Consumer affairs Department of Health and Human Services Disability and paralysis Drug safety, medical device, and laboratory regulation Drug therapy Executive agency funding and structure 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 Health technology, devices, supplies Medical research Prescription drugs User charges and fees Health 00 2012-05-07 Introduced in Senate 2012-07-25T13:39:03Z Food and Drug Administration Safety and Innovation Act - 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 pharmaceutical ingredient facility fee.

Biosimilar User Fee Act of 2012 - Establishes a new program to assess and use fees to expedite the review process for biosimilar biological product applications.

Makes permanent programs to study and provide extended exclusivity periods for new drugs for use in pediatric populations.

Permits the FDA to change a classification of a medical device through an administrative order rather than by regulation.

Expands reporting requirements for manufacturers of prescription drugs.

Provides incentives for the development of new qualified infectious disease products, including: (1) an additional five-year market exclusivity period, and (2) eligibility for priority and fast track review.

Requires the Secretary to: (1) expedite the development and review of new drugs designed to treat a serious or life-threatening disease, and (2) include a risk-benefit analysis in the regulatory decision-making process for prescription drugs.

Revises requirements for the reporting by drug manufacturers to HHS of a discontinuance or interruption in the production of life saving drugs. Requires the Secretary to establish a task force to develop and implement a strategic plan for enhancing the Secretary's response to preventing and mitigating drug shortages.

Extends until October 1, 2017, the deadline for applications for elections relating to marketing exclusivity for certain drugs containing single enantiomers.

Extends through FY2017 the authorization of appropriations for Critical Path Public-Private Partnerships to implement the FDA's Critical Path Initiative.

Provides for the regulation of medical gas products.

Directs the Secretary to: (1) issue guidance explaining FDA policy for promoting FDA-regulated medical products using the Internet and social media; (2) report to Congress on initiatives to combat prescription drug abuse; (3) reconsider tanning bed labeling requirements; and (4) submit an integrated management strategy identifying goals for the FDA Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health.

]]> 80 2012-05-07 Reported to Senate without amendment 2012-09-17T13:52:46Z (This measure has not been amended since it was introduced. The summary of that version is repeated here.)

Food and Drug Administration Safety and Innovation Act - 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 pharmaceutical ingredient facility fee.

Biosimilar User Fee Act of 2012 - Establishes a new program to assess and use fees to expedite the review process for biosimilar biological product applications.

Makes permanent programs to study and provide extended exclusivity periods for new drugs for use in pediatric populations.

Permits the FDA to change a classification of a medical device through an administrative order rather than by regulation.

Expands reporting requirements for manufacturers of prescription drugs.

Provides incentives for the development of new qualified infectious disease products, including: (1) an additional five-year market exclusivity period, and (2) eligibility for priority and fast track review.

Requires the Secretary to: (1) expedite the development and review of new drugs designed to treat a serious or life-threatening disease, and (2) include a risk-benefit analysis in the regulatory decision-making process for prescription drugs.

Revises requirements for the reporting by drug manufacturers to HHS of a discontinuance or interruption in the production of life saving drugs. Requires the Secretary to establish a task force to develop and implement a strategic plan for enhancing the Secretary's response to preventing and mitigating drug shortages.

Extends until October 1, 2017, the deadline for applications for elections relating to marketing exclusivity for certain drugs containing single enantiomers.

Extends through FY2017 the authorization of appropriations for Critical Path Public-Private Partnerships to implement the FDA's Critical Path Initiative.

Provides for the regulation of medical gas products.

Directs the Secretary to: (1) issue guidance explaining FDA policy for promoting FDA-regulated medical products using the Internet and social media; (2) report to Congress on initiatives to combat prescription drug abuse; (3) reconsider tanning bed labeling requirements; and (4) submit an integrated management strategy identifying goals for the FDA Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health.

]]> Food and Drug Administration Safety and Innovation Act Short Titles as Reported to Senate for portions of this bill Medical Device User Fee Amendments of 2012 S Senate Short Titles as Reported to Senate for portions of this bill Generic Drug User Fee Amendments of 2012 S Senate Short Titles as Reported to Senate for portions of this bill Biosimilar User Fee Act of 2012 S Senate Short Titles as Introduced for portions of this bill Prescription Drug User Fee Amendments of 2012 Short Titles as Introduced for portions of this bill Biosimilar User Fee Act of 2012 Short Titles as Introduced for portions of this bill Generic Drug User Fee Amendments of 2012 Short Titles as Reported to Senate for portions of this bill Prescription Drug User Fee Amendments of 2012 S Senate Official Title as Introduced An original bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes. Short Titles as Reported to Senate Food and Drug Administration Safety and Innovation Act S Senate Short Titles as Introduced for portions of this bill Medical Device User Fee Amendments of 2012 Display Title Food and Drug Administration Safety and Innovation Act Short Titles as Introduced Food and Drug Administration Safety and Innovation Act Placed on Calendar Senate 2012-05-07T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112s2516pcs/xml/BILLS-112s2516pcs.xml 2012-05-07 Placed on Senate Legislative Calendar under General Orders. Calendar No. 389. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.