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.
Military Personnel Subcommittee, Armed Services Committee, Energy and Commerce Committee
Introduced
In Committee
On Floor
Passed Chamber
Enacted
(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.
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Timeline
Introduced in House
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.
Referred to the Subcommittee on Military Personnel.
Received in the Senate, read twice.
Mr. Walden moved to suspend the rules and pass the bill.
Considered under suspension of the rules. (consideration: CR H9297-9300)
DEBATE - The House proceeded with forty minutes of debate on H.R. 4374.
Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H9297-9298)
On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H9297-9298)
Motion to reconsider laid on the table Agreed to without objection.
Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(consideration: CR S7270)
Passed Senate without amendment by Unanimous Consent. (consideration: CR S7270)
Message on Senate action sent to the House.
Presented to President.
Signed by President.
Became Public Law No: 115-92.
Introduced in House
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.
Referred to the Subcommittee on Military Personnel.
Received in the Senate, read twice.
Mr. Walden moved to suspend the rules and pass the bill.
Considered under suspension of the rules. (consideration: CR H9297-9300)
DEBATE - The House proceeded with forty minutes of debate on H.R. 4374.
Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H9297-9298)
On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H9297-9298)
Motion to reconsider laid on the table Agreed to without objection.
Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(consideration: CR S7270)
Passed Senate without amendment by Unanimous Consent. (consideration: CR S7270)
Message on Senate action sent to the House.
Presented to President.
Signed by President.
Became Public Law No: 115-92.
Health
Blood and blood diseasesChemical and biological weaponsConflicts and warsDrug safety, medical device, and laboratory regulationDrug therapyEmergency medical services and trauma careGovernment studies and investigationsHealth promotion and preventive careImmunology and vaccinationLicensing and registrationsMilitary medicineNuclear weapons
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.
USA115th CongressHR-4374| House
| Updated: 12/12/2017
(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.
Get AI-generated questions to help you understand this bill better
Timeline
Introduced in House
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.
Referred to the Subcommittee on Military Personnel.
Received in the Senate, read twice.
Mr. Walden moved to suspend the rules and pass the bill.
Considered under suspension of the rules. (consideration: CR H9297-9300)
DEBATE - The House proceeded with forty minutes of debate on H.R. 4374.
Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H9297-9298)
On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H9297-9298)
Motion to reconsider laid on the table Agreed to without objection.
Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(consideration: CR S7270)
Passed Senate without amendment by Unanimous Consent. (consideration: CR S7270)
Message on Senate action sent to the House.
Presented to President.
Signed by President.
Became Public Law No: 115-92.
Introduced in House
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.
Referred to the Subcommittee on Military Personnel.
Received in the Senate, read twice.
Mr. Walden moved to suspend the rules and pass the bill.
Considered under suspension of the rules. (consideration: CR H9297-9300)
DEBATE - The House proceeded with forty minutes of debate on H.R. 4374.
Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H9297-9298)
On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H9297-9298)
Motion to reconsider laid on the table Agreed to without objection.
Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(consideration: CR S7270)
Passed Senate without amendment by Unanimous Consent. (consideration: CR S7270)
Military Personnel Subcommittee, Armed Services Committee, Energy and Commerce Committee
Health
Introduced
In Committee
On Floor
Passed Chamber
Enacted
Blood and blood diseasesChemical and biological weaponsConflicts and warsDrug safety, medical device, and laboratory regulationDrug therapyEmergency medical services and trauma careGovernment studies and investigationsHealth promotion and preventive careImmunology and vaccinationLicensing and registrationsMilitary medicineNuclear weapons