Medical Countermeasure Innovation Act of 2016

Bill: 114-s-2055
Sponsor: Sen. Burr, Richard [R-NC]
Introduced: 2015-09-17 in the Senate
Policy area: Health
Subjects: Animal protection and human-animal relationships
Chemical and biological weapons
Congressional oversight
Drug safety, medical device, and laboratory regulation
Drug therapy
Emergency medical services and trauma care
Government information and archives
Health programs administration and funding
Immunology and vaccination
Infectious and parasitic diseases
Medical research
Nuclear weapons
Research administration and funding
Terrorism
User charges and fees

Summary:
action_date: 2015-09-17
text: 

Medical Countermeasure Innovation Act of 2015

 
This bill amends the Public Health Service Act to require the Department of Health and Human Services (HHS) to ensure the issuance of timely and accurate guidelines regarding the use of medical products for countering public health emergencies or material threats.
 
The Biomedical Advanced Research and Development Authority's contracting authority for procurement of medical countermeasures under Project BioShield is codified. Such procurement no longer requires Presidential approval or an agreement between HHS and the Department of Homeland Security.
 
The Office of the Assistant Secretary for Preparedness and Response must publish its budget plan for medical countermeasures.
 
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to explain delays in finalizing guidance regarding development of animal models to support approval of medical countermeasures.
 
Upon approval, the FDA must award a priority review voucher to the sponsor of a drug or biological product that: (1) is a significant improvement in the prevention, diagnosis, or treatment of a serious condition; and (2) can be used as a medical countermeasure to a material threat. The transferable voucher entitles the holder to have a new medication application acted upon by the FDA within six months.
 
The sponsor of a medication that is subject to a voucher must pay a user fee based on the FDA's cost for the priority review process.
 The FDA must publish a notice each time it issues a voucher or a voucher is used.
action_date: 2016-03-14
text: 

Medical Countermeasure Innovation Act of 2016

 
(Sec. 2) This bill amends the Public Health Service Act to require the Department of Health and Human Services (HHS) to ensure the issuance of timely and accurate guidelines regarding the use of medical products for countering public health emergencies or material threats. HHS must report on funding for procurement of medical countermeasures when available funds are below a specified amount.
 
(Sec. 3) The Biomedical Advanced Research and Development Authority's (BARDA's) contracting authority for procurement of medical countermeasures under Project BioShield is codified.
 
(Sec. 4) The Office of the Assistant Secretary for Preparedness and Response must annually publish its budget plan for medical countermeasures.
 
(Sec. 5) BARDA may enter an agreement with an independent, nongovernmental nonprofit to foster and accelerate the development and innovation of medical countermeasures and related technologies. BARDA must direct and oversee the nonprofit's work and ensure transparency and accountability.
 
(Sec. 6) BARDA's procurement of medical countermeasures no longer requires Presidential approval or an agreement between HHS and the Department of Homeland Security.
 
(Sec. 7) This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to award, upon approval, a priority review voucher to the sponsor of a drug or biological product that: (1) is a significant improvement in the prevention, diagnosis, or treatment of a serious condition; and (2) can be used as a medical countermeasure to a material threat. The transferable voucher entitles the holder to have an application for a new medication acted upon by the FDA within six months.
 
The sponsor of a medication that is subject to a voucher must pay a user fee based on the FDA's cost for the priority review process.
 
The FDA must publish a notice each time it issues a voucher or a voucher is used. 
 
(Sec. 8) The Government Accountability Office must report on the effectiveness of this priority review voucher program in providing incentives for the development of material threat medical countermeasures.


Legislative actions:
action_date: 2016-03-14
text: Placed on Senate Legislative Calendar under General Orders. Calendar No. 388.
action_date: 2016-03-14
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
action_date: 2016-03-14
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
action_date: 2016-03-09
text: Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
action_date: 2015-09-17
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2015-09-17
text: Introduced in Senate