To amend the Federal Food, Drug, and Cosmetic Act to authorize additional emergency uses for medical products to reduce deaths and severity of injuries caused by agents of war, and for other purposes.

Bill: 115-hr-4374
Sponsor: Rep. Walden, Greg [R-OR-2]
Introduced: 2017-11-13 in the House
Policy area: Health
Subjects: Blood and blood diseases
Chemical and biological weapons
Conflicts and wars
Drug safety, medical device, and laboratory regulation
Drug therapy
Emergency medical services and trauma care
Government studies and investigations
Health promotion and preventive care
Immunology and vaccination
Licensing and registrations
Military medicine
Nuclear weapons

Summary:
action_date: 2017-11-13
text: 
This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA) to authorize the emergency use of an otherwise unapproved medical product if the Department of Defense (DOD) determines that there is a military emergency involving an agent that may cause imminently life-threatening and specific risk to U.S. forces. If a military emergency is determined to exist, the bill allows DOD to request that the FDA expedite certain procedures for approving medical products that would be reasonably likely to diagnose, prevent, treat, or mitigate such risk. The FDA must take specified actions to facilitate such a request by DOD.
 
The bill repeals provisions of the National Defense Authorization Act for Fiscal Year 2018 that allow DOD, rather than the FDA, to authorize the emergency use of an unapproved product under similar circumstances.
 
Unless DOD determines such meetings to be unnecessary, the FDA shall meet with DOD: (1) semi-annually to conduct a full review of relevant medical products in the DOD portfolio; and (2) quarterly to discuss the development status of regenerative medicine advanced therapy, blood, and vaccine medical products and projects that DOD prioritizes. 

action_date: 2017-11-15
text: 
(This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)
 
(Sec. 1) This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA) to authorize the emergency use of an otherwise unapproved medical product if the Department of Defense (DOD) determines that there is a military emergency involving an agent that may cause imminently life-threatening and specific risk to U.S. forces. If a military emergency is determined to exist, the bill allows DOD to request that the FDA expedite certain procedures for approving medical products that would be reasonably likely to diagnose, prevent, treat, or mitigate such risk. The FDA must take specified actions to facilitate such a request by DOD.
 
The bill repeals provisions of the National Defense Authorization Act for Fiscal Year 2018 that allow DOD, rather than the FDA, to authorize the emergency use of an unapproved product under similar circumstances.
 
Unless DOD determines such meetings to be unnecessary, the FDA shall meet with DOD: (1) semi-annually to conduct a full review of relevant medical products in the DOD portfolio; and (2) quarterly to discuss the development status of regenerative medicine advanced therapy, blood, and vaccine medical products and projects that DOD prioritizes. 

action_date: 2017-11-16
text: 
(This measure has not been amended since it was introduced. The expanded summary of the House passed version is repeated here.)
 
(Sec. 1) This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA) to authorize the emergency use of an otherwise unapproved medical product if the Department of Defense (DOD) determines that there is a military emergency involving an agent that may cause imminently life-threatening and specific risk to U.S. forces. If a military emergency is determined to exist, the bill allows DOD to request that the FDA expedite certain procedures for approving medical products that would be reasonably likely to diagnose, prevent, treat, or mitigate such risk. The FDA must take specified actions to facilitate such a request by DOD.
 
The bill repeals provisions of the National Defense Authorization Act for Fiscal Year 2018 that allow DOD, rather than the FDA, to authorize the emergency use of an unapproved product under similar circumstances.
 
Unless DOD determines such meetings to be unnecessary, the FDA shall meet with DOD: (1) semi-annually to conduct a full review of relevant medical products in the DOD portfolio; and (2) quarterly to discuss the development status of regenerative medicine advanced therapy, blood, and vaccine medical products and projects that DOD prioritizes. 

action_date: 2017-12-12
text: 
(This measure has not been amended since it was introduced. The expanded summary of the House passed version is repeated here.)
 
(Sec. 1) This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA) to authorize the emergency use of an otherwise unapproved medical product if the Department of Defense (DOD) determines that there is a military emergency involving an agent that may cause imminently life-threatening and specific risk to U.S. forces. If a military emergency is determined to exist, the bill allows DOD to request that the FDA expedite certain procedures for approving medical products that would be reasonably likely to diagnose, prevent, treat, or mitigate such risk. The FDA must take specified actions to facilitate such a request by DOD.
 
The bill repeals provisions of the National Defense Authorization Act for Fiscal Year 2018 that allow DOD, rather than the FDA, to authorize the emergency use of an unapproved product under similar circumstances.
 
Unless DOD determines such meetings to be unnecessary, the FDA shall meet with DOD: (1) semi-annually to conduct a full review of relevant medical products in the DOD portfolio; and (2) quarterly to discuss the development status of regenerative medicine advanced therapy, blood, and vaccine medical products and projects that DOD prioritizes. 


Legislative actions:
action_date: 2017-12-12
text: Signed by President.
action_date: 2017-12-12
text: Signed by President.
action_date: 2017-11-30
text: Presented to President.
action_date: 2017-11-30
text: Presented to President.
action_date: 2017-11-16
text: Message on Senate action sent to the House.
action_date: 2017-11-16
text: Passed Senate without amendment by Unanimous Consent. (consideration: CR S7270)
action_date: 2017-11-16
text: Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(consideration: CR S7270)
action_date: 2017-11-15
text: Received in the Senate, read twice.
action_date: 2017-11-15
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2017-11-15
text: On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H9297-9298)
action_date: 2017-11-15
text: Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H9297-9298)
action_date: 2017-11-15
text: DEBATE - The House proceeded with forty minutes of debate on H.R. 4374.
action_date: 2017-11-15
text: Considered under suspension of the rules. (consideration: CR H9297-9300)
action_date: 2017-11-15
text: Mr. Walden moved to suspend the rules and pass the bill.
action_date: 2017-11-14
text: Referred to the Subcommittee on Military Personnel.
action_date: 2017-11-13
text: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Armed Services, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
action_date: 2017-11-13
text: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Armed Services, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
action_date: 2017-11-13
text: Introduced in House
action_date: 2017-11-13
text: Introduced in House

Enacted as: number: 115-92