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: full_name: Rep. Walden, Greg [R-OR-2]
Introduced: 2017-11-13
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
Latest action: action_date: 2017-12-12
text: Signed by President.

Summaries:
action_date: 2017-11-13
action_desc: Introduced in House
text: <p>This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA)&nbsp;to authorize&nbsp;the emergency use of an otherwise unapproved&nbsp;medical product if the Department of Defense (DOD)&nbsp;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&nbsp;expedite certain procedures for approving medical&nbsp;products that would be reasonably likely to diagnose, prevent, treat, or mitigate such risk.&nbsp;The FDA&nbsp;must take specified&nbsp;actions to facilitate such a request by DOD.</p> <p>The bill repeals provisions of the National Defense Authorization Act for Fiscal Year 2018 that allow DOD, rather than the FDA,&nbsp;to authorize the emergency use of an unapproved product under similar circumstances.</p> <p>Unless DOD determines&nbsp;such meetings to be unnecessary, the FDA shall meet with&nbsp;DOD:&nbsp;(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. </p>

action_date: 2017-11-15
action_desc: Passed House without amendment
text: <p>(This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)</p> <p>(Sec. 1) This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA)&nbsp;to authorize&nbsp;the emergency use of an otherwise unapproved&nbsp;medical product if the Department of Defense (DOD)&nbsp;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&nbsp;expedite certain procedures for approving medical&nbsp;products that would be reasonably likely to diagnose, prevent, treat, or mitigate such risk.&nbsp;The FDA&nbsp;must take specified&nbsp;actions to facilitate such a request by DOD.</p> <p>The bill repeals provisions of the National Defense Authorization Act for Fiscal Year 2018 that allow DOD, rather than the FDA,&nbsp;to authorize the emergency use of an unapproved product under similar circumstances.</p> <p>Unless DOD determines&nbsp;such meetings to be unnecessary, the FDA shall meet with&nbsp;DOD:&nbsp;(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. </p>

action_date: 2017-11-16
action_desc: Passed Senate without amendment
text: <p>(This measure has not been amended since it was introduced. The expanded summary of the House passed version is repeated here.)</p> <p>(Sec. 1) This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA)&nbsp;to authorize&nbsp;the emergency use of an otherwise unapproved&nbsp;medical product if the Department of Defense (DOD)&nbsp;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&nbsp;expedite certain procedures for approving medical&nbsp;products that would be reasonably likely to diagnose, prevent, treat, or mitigate such risk.&nbsp;The FDA&nbsp;must take specified&nbsp;actions to facilitate such a request by DOD.</p> <p>The bill repeals provisions of the National Defense Authorization Act for Fiscal Year 2018 that allow DOD, rather than the FDA,&nbsp;to authorize the emergency use of an unapproved product under similar circumstances.</p> <p>Unless DOD determines&nbsp;such meetings to be unnecessary, the FDA shall meet with&nbsp;DOD:&nbsp;(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. </p>

action_date: 2017-12-12
action_desc: Public Law
text: <p>(This measure has not been amended since it was introduced. The expanded summary of the House passed version is repeated here.)</p> <p>(Sec. 1) This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA)&nbsp;to authorize&nbsp;the emergency use of an otherwise unapproved&nbsp;medical product if the Department of Defense (DOD)&nbsp;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&nbsp;expedite certain procedures for approving medical&nbsp;products that would be reasonably likely to diagnose, prevent, treat, or mitigate such risk.&nbsp;The FDA&nbsp;must take specified&nbsp;actions to facilitate such a request by DOD.</p> <p>The bill repeals provisions of the National Defense Authorization Act for Fiscal Year 2018 that allow DOD, rather than the FDA,&nbsp;to authorize the emergency use of an unapproved product under similar circumstances.</p> <p>Unless DOD determines&nbsp;such meetings to be unnecessary, the FDA shall meet with&nbsp;DOD:&nbsp;(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. </p>

tv_txt: I 115th CONGRESS 1st Session H. R. 4374 IN THE HOUSE OF REPRESENTATIVES AN ACT 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.

1. Additional emergency uses for medical products to reduce deaths and severity of injuries caused by agents of war (a) FDA authorization for medical products for use in emergencies Section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3 ) is amended— (1) in subsection (b)— (A) in paragraph (1), by amending subparagraph (B) to read as follows: (B) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces, including personnel operating under the authority of title 10 or title 50, United States Code, of attack with— (i) a biological, chemical, radiological, or nuclear agent or agents; or (ii) an agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to United States military forces; ; and (B) by adding at the end the following: (6) Military emergencies In the case of a determination described in paragraph (1)(B), the Secretary shall determine, within 45 calendar days of such determination, whether to make a declaration under paragraph (1), and, if appropriate, shall promptly make such a declaration. ; and (2) in subsection (c)— (A) in paragraph (3), by striking ; and and inserting ; ; (B) by redesignating paragraph (4) as paragraph (5); and (C) by inserting after paragraph (3) the following: (4) in the case of a determination described in subsection (b)(1)(B)(ii), that the request for emergency use is made by the Secretary of Defense; and . (b) Emergency uses for medical products (1) In general The Secretary of Defense may request that the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, take actions to expedite the development of a medical product, review of investigational new drug applications under section 505(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i) ), review of investigational device exemptions under section 520(g) of such Act ( 21 U.S.C. 360j(g) ), and review of applications for approval and clearance of medical products under sections 505, 510(k), and 515 of such Act ( 21 U.S.C. 355 , 360(k), 360(e)) and section 351 of the Public Health Service Act ( 42 U.S.C. 262 ), including applications for licensing of vaccines or blood as biological products under such section 351, or applications for review of regenerative medicine advanced therapy products under section 506(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356(g) ), if there is a military emergency, or significant potential for a military emergency, involving a specific and imminently life-threatening risk to United States military forces of attack with an agent or agents, and the medical product that is the subject of such application, submission, or notification would be reasonably likely to diagnose, prevent, treat, or mitigate such life-threatening risk. (2) Actions Upon a request by the Secretary of Defense under paragraph (1), the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall take action to expedite the development and review of an applicable application or notification with respect to a medical product described in paragraph (1), which may include, as appropriate— (A) holding meetings with the sponsor and the review team throughout the development of the medical product; (B) providing timely advice to, and interactive communication with, the sponsor regarding the development of the medical product to ensure that the development program to gather the nonclinical and clinical data necessary for approval or clearance is as efficient as practicable; (C) involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review; (D) assigning a cross-disciplinary project lead for the review team to facilitate an efficient review of the development program and to serve as a scientific liaison between the review team and the sponsor; (E) taking steps to ensure that the design of the clinical trials is as efficient as practicable, when scientifically appropriate, such as by minimizing the number of patients exposed to a potentially less efficacious treatment; (F) applying any applicable Food and Drug Administration program intended to expedite the development and review of a medical product; and (G) in appropriate circumstances, permitting expanded access to the medical product during the investigational phase, in accordance with applicable requirements of the Food and Drug Administration. (3) Enhanced collaboration and communication In order to facilitate enhanced collaboration and communication with respect to the most current priorities of the Department of Defense— (A) the Food and Drug Administration shall meet with the Department of Defense and any other appropriate development partners, such as the Biomedical Advanced Research and Development Authority, on a semi-annual basis for the purposes of conducting a full review of the relevant products in the Department of Defense portfolio; and (B) the Director of the Center for Biologics Evaluation and Research shall meet quarterly with the Department of Defense to discuss the development status of regenerative medicine advanced therapy, blood, and vaccine medical products and projects that are the highest priorities to the Department of Defense (which may include freeze dried plasma products and platelet alternatives), unless the Secretary of Defense determines that any such meetings are not necessary. (4) Medical product In this subsection, the term medical product means a drug (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 )), a device (as defined in such section 201), or a biological product (as defined in section 351 of the Public Health Service Act ( 42 U.S.C. 262 )). (c) Repeal Effective as of the enactment of the National Defense Authorization Act for Fiscal Year 2018, subsection (d) of section 1107a of title 10, United States Code, as added by section 716 of the National Defense Authorization Act for Fiscal Year 2018, is repealed.

Passed the House of Representatives November 15, 2017. Karen L. Haas, Clerk.

tv_txt: I One Hundred Fifteenth Congress of the United States of America At the First Session Begun and held at the City of Washington on Tuesday, the third day of January, two thousand and seventeen H. R. 4374 AN ACT 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.

1. Additional emergency uses for medical products to reduce deaths and severity of injuries caused by agents of war (a) FDA authorization for medical products for use in emergencies Section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3 ) is amended— (1) in subsection (b)— (A) in paragraph (1), by amending subparagraph (B) to read as follows: (B) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces, including personnel operating under the authority of title 10 or title 50, United States Code, of attack with— (i) a biological, chemical, radiological, or nuclear agent or agents; or (ii) an agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to United States military forces; ; and (B) by adding at the end the following: (6) Military emergencies In the case of a determination described in paragraph (1)(B), the Secretary shall determine, within 45 calendar days of such determination, whether to make a declaration under paragraph (1), and, if appropriate, shall promptly make such a declaration. ; and (2) in subsection (c)— (A) in paragraph (3), by striking ; and and inserting ; ; (B) by redesignating paragraph (4) as paragraph (5); and (C) by inserting after paragraph (3) the following: (4) in the case of a determination described in subsection (b)(1)(B)(ii), that the request for emergency use is made by the Secretary of Defense; and . (b) Emergency uses for medical products (1) In general The Secretary of Defense may request that the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, take actions to expedite the development of a medical product, review of investigational new drug applications under section 505(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i) ), review of investigational device exemptions under section 520(g) of such Act ( 21 U.S.C. 360j(g) ), and review of applications for approval and clearance of medical products under sections 505, 510(k), and 515 of such Act ( 21 U.S.C. 355 , 360(k), 360(e)) and section 351 of the Public Health Service Act ( 42 U.S.C. 262 ), including applications for licensing of vaccines or blood as biological products under such section 351, or applications for review of regenerative medicine advanced therapy products under section 506(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356(g) ), if there is a military emergency, or significant potential for a military emergency, involving a specific and imminently life-threatening risk to United States military forces of attack with an agent or agents, and the medical product that is the subject of such application, submission, or notification would be reasonably likely to diagnose, prevent, treat, or mitigate such life-threatening risk. (2) Actions Upon a request by the Secretary of Defense under paragraph (1), the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall take action to expedite the development and review of an applicable application or notification with respect to a medical product described in paragraph (1), which may include, as appropriate— (A) holding meetings with the sponsor and the review team throughout the development of the medical product; (B) providing timely advice to, and interactive communication with, the sponsor regarding the development of the medical product to ensure that the development program to gather the nonclinical and clinical data necessary for approval or clearance is as efficient as practicable; (C) involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review; (D) assigning a cross-disciplinary project lead for the review team to facilitate an efficient review of the development program and to serve as a scientific liaison between the review team and the sponsor; (E) taking steps to ensure that the design of the clinical trials is as efficient as practicable, when scientifically appropriate, such as by minimizing the number of patients exposed to a potentially less efficacious treatment; (F) applying any applicable Food and Drug Administration program intended to expedite the development and review of a medical product; and (G) in appropriate circumstances, permitting expanded access to the medical product during the investigational phase, in accordance with applicable requirements of the Food and Drug Administration. (3) Enhanced collaboration and communication In order to facilitate enhanced collaboration and communication with respect to the most current priorities of the Department of Defense— (A) the Food and Drug Administration shall meet with the Department of Defense and any other appropriate development partners, such as the Biomedical Advanced Research and Development Authority, on a semi-annual basis for the purposes of conducting a full review of the relevant products in the Department of Defense portfolio; and (B) the Director of the Center for Biologics Evaluation and Research shall meet quarterly with the Department of Defense to discuss the development status of regenerative medicine advanced therapy, blood, and vaccine medical products and projects that are the highest priorities to the Department of Defense (which may include freeze dried plasma products and platelet alternatives), unless the Secretary of Defense determines that any such meetings are not necessary. (4) Medical product In this subsection, the term medical product means a drug (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 )), a device (as defined in such section 201), or a biological product (as defined in section 351 of the Public Health Service Act ( 42 U.S.C. 262 )). (c) Repeal Effective as of the enactment of the National Defense Authorization Act for Fiscal Year 2018, subsection (d) of section 1107a of title 10, United States Code, as added by section 716 of the National Defense Authorization Act for Fiscal Year 2018, is repealed.

Speaker of the House of Representatives. Vice President of the United States and President of the Senate.

tv_txt: I 115th CONGRESS 1st Session H. R. 4374 IN THE HOUSE OF REPRESENTATIVES November 13, 2017 Mr. Walden introduced the following bill; which was 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 A BILL 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.

1. Additional emergency uses for medical products to reduce deaths and severity of injuries caused by agents of war (a) FDA authorization for medical products for use in emergencies Section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3 ) is amended— (1) in subsection (b)— (A) in paragraph (1), by amending subparagraph (B) to read as follows: (B) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces, including personnel operating under the authority of title 10 or title 50, United States Code, of attack with— (i) a biological, chemical, radiological, or nuclear agent or agents; or (ii) an agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to United States military forces; ; and (B) by adding at the end the following: (6) Military emergencies In the case of a determination described in paragraph (1)(B), the Secretary shall determine, within 45 calendar days of such determination, whether to make a declaration under paragraph (1), and, if appropriate, shall promptly make such a declaration. ; and (2) in subsection (c)— (A) in paragraph (3), by striking ; and and inserting ; ; (B) by redesignating paragraph (4) as paragraph (5); and (C) by inserting after paragraph (3) the following: (4) in the case of a determination described in subsection (b)(1)(B)(ii), that the request for emergency use is made by the Secretary of Defense; and . (b) Emergency uses for medical products (1) In general The Secretary of Defense may request that the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, take actions to expedite the development of a medical product, review of investigational new drug applications under section 505(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i) ), review of investigational device exemptions under section 520(g) of such Act ( 21 U.S.C. 360j(g) ), and review of applications for approval and clearance of medical products under sections 505, 510(k), and 515 of such Act ( 21 U.S.C. 355 , 360(k), 360(e)) and section 351 of the Public Health Service Act ( 42 U.S.C. 262 ), including applications for licensing of vaccines or blood as biological products under such section 351, or applications for review of regenerative medicine advanced therapy products under section 506(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356(g) ), if there is a military emergency, or significant potential for a military emergency, involving a specific and imminently life-threatening risk to United States military forces of attack with an agent or agents, and the medical product that is the subject of such application, submission, or notification would be reasonably likely to diagnose, prevent, treat, or mitigate such life-threatening risk. (2) Actions Upon a request by the Secretary of Defense under paragraph (1), the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall take action to expedite the development and review of an applicable application or notification with respect to a medical product described in paragraph (1), which may include, as appropriate— (A) holding meetings with the sponsor and the review team throughout the development of the medical product; (B) providing timely advice to, and interactive communication with, the sponsor regarding the development of the medical product to ensure that the development program to gather the nonclinical and clinical data necessary for approval or clearance is as efficient as practicable; (C) involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review; (D) assigning a cross-disciplinary project lead for the review team to facilitate an efficient review of the development program and to serve as a scientific liaison between the review team and the sponsor; (E) taking steps to ensure that the design of the clinical trials is as efficient as practicable, when scientifically appropriate, such as by minimizing the number of patients exposed to a potentially less efficacious treatment; (F) applying any applicable Food and Drug Administration program intended to expedite the development and review of a medical product; and (G) in appropriate circumstances, permitting expanded access to the medical product during the investigational phase, in accordance with applicable requirements of the Food and Drug Administration. (3) Enhanced collaboration and communication In order to facilitate enhanced collaboration and communication with respect to the most current priorities of the Department of Defense— (A) the Food and Drug Administration shall meet with the Department of Defense and any other appropriate development partners, such as the Biomedical Advanced Research and Development Authority, on a semi-annual basis for the purposes of conducting a full review of the relevant products in the Department of Defense portfolio; and (B) the Director of the Center for Biologics Evaluation and Research shall meet quarterly with the Department of Defense to discuss the development status of regenerative medicine advanced therapy, blood, and vaccine medical products and projects that are the highest priorities to the Department of Defense (which may include freeze dried plasma products and platelet alternatives), unless the Secretary of Defense determines that any such meetings are not necessary. (4) Medical product In this subsection, the term medical product means a drug (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 )), a device (as defined in such section 201), or a biological product (as defined in section 351 of the Public Health Service Act ( 42 U.S.C. 262 )). (c) Repeal Effective as of the enactment of the National Defense Authorization Act for Fiscal Year 2018, subsection (d) of section 1107a of title 10, United States Code, as added by section 716 of the National Defense Authorization Act for Fiscal Year 2018, is repealed.

tv_txt: II 115th CONGRESS 1st Session H. R. 4374 IN THE SENATE OF THE UNITED STATES November 15, 2017 Received AN ACT 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.

1. Additional emergency uses for medical products to reduce deaths and severity of injuries caused by agents of war (a) FDA authorization for medical products for use in emergencies Section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3 ) is amended— (1) in subsection (b)— (A) in paragraph (1), by amending subparagraph (B) to read as follows: (B) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces, including personnel operating under the authority of title 10 or title 50, United States Code, of attack with— (i) a biological, chemical, radiological, or nuclear agent or agents; or (ii) an agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to United States military forces; ; and (B) by adding at the end the following: (6) Military emergencies In the case of a determination described in paragraph (1)(B), the Secretary shall determine, within 45 calendar days of such determination, whether to make a declaration under paragraph (1), and, if appropriate, shall promptly make such a declaration. ; and (2) in subsection (c)— (A) in paragraph (3), by striking ; and and inserting ; ; (B) by redesignating paragraph (4) as paragraph (5); and (C) by inserting after paragraph (3) the following: (4) in the case of a determination described in subsection (b)(1)(B)(ii), that the request for emergency use is made by the Secretary of Defense; and . (b) Emergency uses for medical products (1) In general The Secretary of Defense may request that the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, take actions to expedite the development of a medical product, review of investigational new drug applications under section 505(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i) ), review of investigational device exemptions under section 520(g) of such Act ( 21 U.S.C. 360j(g) ), and review of applications for approval and clearance of medical products under sections 505, 510(k), and 515 of such Act ( 21 U.S.C. 355 , 360(k), 360(e)) and section 351 of the Public Health Service Act ( 42 U.S.C. 262 ), including applications for licensing of vaccines or blood as biological products under such section 351, or applications for review of regenerative medicine advanced therapy products under section 506(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356(g) ), if there is a military emergency, or significant potential for a military emergency, involving a specific and imminently life-threatening risk to United States military forces of attack with an agent or agents, and the medical product that is the subject of such application, submission, or notification would be reasonably likely to diagnose, prevent, treat, or mitigate such life-threatening risk. (2) Actions Upon a request by the Secretary of Defense under paragraph (1), the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall take action to expedite the development and review of an applicable application or notification with respect to a medical product described in paragraph (1), which may include, as appropriate— (A) holding meetings with the sponsor and the review team throughout the development of the medical product; (B) providing timely advice to, and interactive communication with, the sponsor regarding the development of the medical product to ensure that the development program to gather the nonclinical and clinical data necessary for approval or clearance is as efficient as practicable; (C) involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review; (D) assigning a cross-disciplinary project lead for the review team to facilitate an efficient review of the development program and to serve as a scientific liaison between the review team and the sponsor; (E) taking steps to ensure that the design of the clinical trials is as efficient as practicable, when scientifically appropriate, such as by minimizing the number of patients exposed to a potentially less efficacious treatment; (F) applying any applicable Food and Drug Administration program intended to expedite the development and review of a medical product; and (G) in appropriate circumstances, permitting expanded access to the medical product during the investigational phase, in accordance with applicable requirements of the Food and Drug Administration. (3) Enhanced collaboration and communication In order to facilitate enhanced collaboration and communication with respect to the most current priorities of the Department of Defense— (A) the Food and Drug Administration shall meet with the Department of Defense and any other appropriate development partners, such as the Biomedical Advanced Research and Development Authority, on a semi-annual basis for the purposes of conducting a full review of the relevant products in the Department of Defense portfolio; and (B) the Director of the Center for Biologics Evaluation and Research shall meet quarterly with the Department of Defense to discuss the development status of regenerative medicine advanced therapy, blood, and vaccine medical products and projects that are the highest priorities to the Department of Defense (which may include freeze dried plasma products and platelet alternatives), unless the Secretary of Defense determines that any such meetings are not necessary. (4) Medical product In this subsection, the term medical product means a drug (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 )), a device (as defined in such section 201), or a biological product (as defined in section 351 of the Public Health Service Act ( 42 U.S.C. 262 )). (c) Repeal Effective as of the enactment of the National Defense Authorization Act for Fiscal Year 2018, subsection (d) of section 1107a of title 10, United States Code, as added by section 716 of the National Defense Authorization Act for Fiscal Year 2018, is repealed.

Passed the House of Representatives November 15, 2017. Karen L. Haas, Clerk