Food and Drug Administration Safety and Innovation Act

Bill: 112-s-2516
Sponsor: Sen. Harkin, Tom [D-IA]
Introduced: 2012-05-07 in the Senate
Policy area: Health
Subjects: 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

Summary:
action_date: 2012-05-07
text: 
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.

action_date: 2012-05-07
text: 

(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.


Legislative actions:
action_date: 2012-05-07
text: Placed on Senate Legislative Calendar under General Orders. Calendar No. 389.
action_date: 2012-05-07
text: Committee on Health, Education, Labor, and Pensions. Original measure reported to Senate by Senator Harkin. Without written report.
action_date: 2012-05-07
text: Committee on Health, Education, Labor, and Pensions. Original measure reported to Senate by Senator Harkin. Without written report.
action_date: 2012-05-07
text: Introduced in Senate