Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017

Bill: 115-s-204
Sponsor: full_name: Sen. Johnson, Ron [R-WI]
Introduced: 2017-01-24
Policy area: Health
Subjects: Civil actions and liability

Drug safety, medical device, and laboratory regulation

Drug therapy

Health technology, devices, supplies

Long-term, rehabilitative, and terminal care

Prescription drugs

Product safety and quality
Latest action: action_date: 2018-05-30
text: Became Public Law No: 115-176.

Summaries:
action_date: 2017-01-24
action_desc: Introduced in Senate
text: <p><b>Trickett Wendler Right to Try Act of 2017</b></p> <p>This bill requires the federal government to allow unrestricted manufacturing, distribution, prescribing, and dispensing of experimental drugs, biological products, and medical devices that are: (1) intended to treat a patient who has been diagnosed with a terminal illness, and (2) authorized by state law. The federal government must allow unrestricted possession and use of such treatments by patients certified by a physician as having exhausted all other treatment options.</p> <p>A manufacturer, distributor, prescriber, dispenser, possessor, or user of such a treatment has no liability regarding the treatment.</p> <p>The outcome of manufacture, distribution, prescribing, dispensing, possession, or use of such a treatment may not be used by a federal agency to adversely impact review or approval of the treatment.</p> <p>The treatment must: (1) have successfully completed a phase 1 (initial, small scale) clinical trial; (2) remain under investigation in a clinical trial approved by the Food and Drug Administration; and (3) not be approved, licensed, or cleared for sale under the Federal Food, Drug, or Cosmetic Act or the Public Health Service Act.</p> <ul> </ul>

action_date: 2017-08-03
action_desc: Passed Senate amended
text: <p><b>Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017</b></p> <p>This bill amends the Federal Food, Drug, and Cosmetic Act to exempt,&nbsp;from&nbsp;specified requirements and restrictions under that Act and other laws, the provision of certain unapproved, investigational drugs to a terminally ill patient who has exhausted approved treatment options and&nbsp;is unable to participate in a clinical trial involving the drugs. The manufacturer or sponsor of an eligible investigational drug must report annually to the Food and Drug Administration (FDA) on any use of&nbsp;the drug in accordance with these provisions. The FDA shall post an annual summary report of such use on its website.</p> <p>The bill limits&nbsp;the liability of&nbsp;a sponsor, manufacturer, prescriber,&nbsp;or dispenser that provides, or declines to provide, an eligible investigational drug to an eligible patient in accordance with the bill.</p> <ul></ul>

action_date: 2018-05-22
action_desc: Passed House without amendment
text: <p><b>Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017</b></p> <p>(Sec.2)This bill amends the Federal Food, Drug, and Cosmetic Act to exempt,&nbsp;from&nbsp;specified requirements and restrictions under that Act and other laws, the provision of certain unapproved, investigational drugs to a terminally ill patient who has exhausted approved treatment options and&nbsp;is unable to participate in a clinical trial involving the drugs. The manufacturer or sponsor of an eligible investigational drug must report annually to the Food and Drug Administration (FDA) on any use of&nbsp;the drug in accordance with these provisions. The FDA shall post an annual summary report of such use on its website.</p> <p>The bill limits&nbsp;the liability of&nbsp;a sponsor, manufacturer, prescriber,&nbsp;or dispenser that provides, or declines to provide, an eligible investigational drug to an eligible patient in accordance with the bill.</p> <ul></ul>

action_date: 2018-05-30
action_desc: Public Law
text: <p><b>Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017</b></p> <p>(Sec.2)This bill amends the Federal Food, Drug, and Cosmetic Act to exempt,&nbsp;from&nbsp;specified requirements and restrictions under that Act and other laws, the provision of certain unapproved, investigational drugs to a terminally ill patient who has exhausted approved treatment options and&nbsp;is unable to participate in a clinical trial involving the drugs. The manufacturer or sponsor of an eligible investigational drug must report annually to the Food and Drug Administration (FDA) on any use of&nbsp;the drug in accordance with these provisions. The FDA shall post an annual summary report of such use on its website.</p> <p>The bill limits&nbsp;the liability of&nbsp;a sponsor, manufacturer, prescriber,&nbsp;or dispenser that provides, or declines to provide, an eligible investigational drug to an eligible patient in accordance with the bill.</p> <ul></ul>

tv_txt: II 115th CONGRESS 1st Session S. 204 IN THE SENATE OF THE UNITED STATES January 24, 2017 Mr. Johnson (for himself, Mr. Barrasso , Mr. Blunt , Mr. Boozman , Mrs. Capito , Mr. Cochran , Mr. Corker , Mr. Cotton , Mr. Crapo , Mr. Cruz , Mr. Daines , Mr. Donnelly , Mr. Enzi , Mrs. Fischer , Mr. Flake , Mr. Gardner , Mr. Graham , Mr. Grassley , Mr. Hatch , Mr. Heller , Mr. Hoeven , Mr. Inhofe , Mr. Isakson , Mr. Kennedy , Mr. King , Mr. Lankford , Mr. Lee , Mr. Manchin , Mr. McCain , Mr. McConnell , Mr. Moran , Ms. Murkowski , Mr. Paul , Mr. Perdue , Mr. Risch , Mr. Rounds , Mr. Rubio , Mr. Sasse , Mr. Shelby , Mr. Sullivan , Mr. Tillis , Mr. Toomey , Mr. Wicker , and Mr. Young ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes.

1. Short title This Act may be cited as the Trickett Wendler Right to Try Act of 2017 . 2. Use of unapproved medical products by patients diagnosed with a terminal illness (a) In general Notwithstanding the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq.), the Controlled Substances Act ( 21 U.S.C. 801 et seq.), and any other provision of Federal law, the Federal Government shall not take any action to prohibit or restrict— (1) the production, manufacture, distribution, prescribing, or dispensing of an experimental drug, biological product, or device that— (A) is intended to treat a patient who has been diagnosed with a terminal illness; and (B) is authorized by, and in accordance with, State law; and (2) the possession or use of an experimental drug, biological product, or device— (A) that is described in subparagraphs (A) and (B) of paragraph (1); and (B) for which the patient has received a certification from a physician, who is in good standing with the physician's certifying organization or board, that the patient has exhausted, or otherwise does not meet qualifying criteria to receive, any other available treatment options. (b) No liability or use of outcomes (1) No liability Notwithstanding any other provision of law, no liability shall lie against a producer, manufacturer, distributor, prescriber, dispenser, possessor, or user of an experimental drug, biological product, or device for the production, manufacture, distribution, prescribing, dispensing, possession, or use of an experimental drug, biological product, or device that is in compliance with subsection (a). (2) No use of outcomes Notwithstanding any other provision of law, the outcome of any production, manufacture, distribution, prescribing, dispensing, possession, or use of an experimental drug, biological product, or device that was done in compliance with subsection (a) shall not be used by a Federal agency reviewing the experimental drug, biological product, or device to delay or otherwise adversely impact review or approval of such experimental drug, biological product, or device. (c) Definitions In this section: (1) Biological product The term biological product has the meaning given to such term in section 351 of the Public Health Service Act ( 42 U.S.C. 262 ). (2) Device; drug The terms device and drug have the meanings given to such terms in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 ). (3) Experimental drug, biological product, or device The term experimental drug, biological product, or device means a drug, biological product, or device that— (A) has successfully completed a phase 1 clinical investigation; (B) remains under investigation in a clinical trial approved by the Food and Drug Administration; and (C) is not approved, licensed, or cleared for commercial distribution under section 505, 510(k), or 515 of the Federal Food, Drug, or Cosmetic Act ( 21 U.S.C. 355 , 360(k), 360(e)) or section 351 of the Public Health Service Act ( 42 U.S.C. 262 ). (4) Phase 1 clinical investigation The term phase 1 clinical investigation means a phase 1 clinical investigation, as described in section 312.21 of title 21, Code of Federal Regulations (or any successor regulations). (5) Terminal illness The term terminal illness has the meaning given to such term in the State law specified in subsection (a)(1)(B).

tv_txt: 115th CONGRESS 1st Session S. 204 IN THE SENATE OF THE UNITED STATES AN ACT To authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes.

1. Short title This Act may be cited as the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 . 2. Use of unapproved investigational drugs by patients diagnosed with a terminal illness (a) In general Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 561A ( 21 U.S.C. 360bbb–0 ) the following: 561B. Investigational drugs for use by eligible patients (a) Definitions For purposes of this section— (1) the term eligible patient means a patient— (A) who has been diagnosed with a life-threatening disease or condition (as defined in section 312.81 of title 21, Code of Federal Regulations (or any successor regulations)); (B) who has exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug, as certified by a physician, who— (i) is in good standing with the physician’s licensing organization or board; and (ii) will not be compensated directly by the manufacturer for so certifying; and (C) who has provided to the treating physician written informed consent regarding the eligible investigational drug, or, as applicable, on whose behalf a legally authorized representative of the patient has provided such consent; (2) the term eligible investigational drug means an investigational drug (as such term is used in section 561)— (A) for which a Phase 1 clinical trial has been completed; (B) that has not been approved or licensed for any use under section 505 of this Act or section 351 of the Public Health Service Act; (C) (i) for which an application has been filed under section 505(b) of this Act or section 351(a) of the Public Health Service Act; or (ii) that is under investigation in a clinical trial that— (I) is intended to form the primary basis of a claim of effectiveness in support of approval or licensure under section 505 of this Act or section 351 of the Public Health Service Act; and (II) is the subject of an active investigational new drug application under section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act, as applicable; and (D) the active development or production of which is ongoing and has not been discontinued by the manufacturer or placed on clinical hold under section 505(i); and (3) the term phase 1 trial means a phase 1 clinical investigation of a drug as described in section 312.21 of title 21, Code of Federal Regulations (or any successor regulations). (b) Exemptions Eligible investigational drugs provided to eligible patients in compliance with this section are exempt from sections 502(f), 503(b)(4), 505(a), and 505(i) of this Act, section 351(a) of the Public Health Service Act, and parts 50, 56, and 312 of title 21, Code of Federal Regulations (or any successor regulations), provided that the sponsor of such eligible investigational drug or any person who manufactures, distributes, prescribes, dispenses, introduces or delivers for introduction into interstate commerce, or provides to an eligible patient an eligible investigational drug pursuant to this section is in compliance with the applicable requirements set forth in sections 312.6, 312.7, and 312.8(d)(1) of title 21, Code of Federal Regulations (or any successor regulations) that apply to investigational drugs. (c) Use of clinical outcomes (1) In general Notwithstanding any other provision of this Act, the Public Health Service Act, or any other provision of Federal law, the Secretary may not use a clinical outcome associated with the use of an eligible investigational drug pursuant to this section to delay or adversely affect the review or approval of such drug under section 505 of this Act or section 351 of the Public Health Service Act unless— (A) the Secretary makes a determination, in accordance with paragraph (2), that use of such clinical outcome is critical to determining the safety of the eligible investigational drug; or (B) the sponsor requests use of such outcomes. (2) Limitation If the Secretary makes a determination under paragraph (1)(A), the Secretary shall provide written notice of such determination to the sponsor, including a public health justification for such determination, and such notice shall be made part of the administrative record. Such determination shall not be delegated below the director of the agency center that is charged with the premarket review of the eligible investigational drug. (d) Reporting (1) In general The manufacturer or sponsor of an eligible investigational drug shall submit to the Secretary an annual summary of any use of such drug under this section. The summary shall include the number of doses supplied, the number of patients treated, the uses for which the drug was made available, and any known serious adverse events. The Secretary shall specify by regulation the deadline of submission of such annual summary and may amend section 312.33 of title 21, Code of Federal Regulations (or any successor regulations) to require the submission of such annual summary in conjunction with the annual report for an applicable investigational new drug application for such drug. (2) Posting of information The Secretary shall post an annual summary report of the use of this section on the internet website of the Food and Drug Administration, including the number of drugs for which clinical outcomes associated with the use of an eligible investigational drug pursuant to this section was— (A) used in accordance with subsection (c)(1)(A); (B) used in accordance with subsection (c)(1)(B); and (C) not used in the review of an application under section 505 of this Act or section 351 of the Public Health Service Act. . (b) No Liability (1) Alleged acts or omissions With respect to any alleged act or omission with respect to an eligible investigational drug provided to an eligible patient pursuant to section 561B of the Federal Food, Drug, and Cosmetic Act and in compliance with such section, no liability in a cause of action shall lie against— (A) a sponsor or manufacturer; or (B) a prescriber, dispenser, or other individual entity (other than a sponsor or manufacturer), unless the relevant conduct constitutes reckless or willful misconduct, gross negligence, or an intentional tort under any applicable State law. (2) Determination not to provide drug No liability shall lie against a sponsor manufacturer, prescriber, dispenser or other individual entity for its determination not to provide access to an eligible investigational drug under section 561B of the Federal Food, Drug, and Cosmetic Act. (3) Limitation Except as set forth in paragraphs (1) and (2), nothing in this section shall be construed to modify or otherwise affect the right of any person to bring a private action under any State or Federal product liability, tort, consumer protection, or warranty law. 3. Sense of the Senate It is the sense of the Senate that section 561B of the Federal Food, Drug, and Cosmetic Act, as added by section 2— (1) does not establish a new entitlement or modify an existing entitlement, or otherwise establish a positive right to any party or individual; (2) does not establish any new mandates, directives, or additional regulations; (3) only expands the scope of individual liberty and agency among patients, in limited circumstances; (4) is consistent with, and will act as an alternative pathway alongside, existing expanded access policies of the Food and Drug Administration; (5) will not, and cannot, create a cure or effective therapy where none exists; (6) recognizes that the eligible terminally ill patient population often consists of those patients with the highest risk of mortality, and use of experimental treatments under the criteria and procedure described in such section 561A involves an informed assumption of risk; and (7) establishes national standards and rules by which investigational drugs may be provided to terminally ill patients.

Passed the Senate August 3, 2017. Secretary

tv_txt: IC 115th CONGRESS 1st Session S. 204 IN THE HOUSE OF REPRESENTATIVES August 4, 2017 Referred to the Committee on Energy and Commerce AN ACT To authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes.

1. Short title This Act may be cited as the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 . 2. Use of unapproved investigational drugs by patients diagnosed with a terminal illness (a) In general Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 561A ( 21 U.S.C. 360bbb–0 ) the following: 561B. Investigational drugs for use by eligible patients (a) Definitions For purposes of this section— (1) the term eligible patient means a patient— (A) who has been diagnosed with a life-threatening disease or condition (as defined in section 312.81 of title 21, Code of Federal Regulations (or any successor regulations)); (B) who has exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug, as certified by a physician, who— (i) is in good standing with the physician’s licensing organization or board; and (ii) will not be compensated directly by the manufacturer for so certifying; and (C) who has provided to the treating physician written informed consent regarding the eligible investigational drug, or, as applicable, on whose behalf a legally authorized representative of the patient has provided such consent; (2) the term eligible investigational drug means an investigational drug (as such term is used in section 561)— (A) for which a Phase 1 clinical trial has been completed; (B) that has not been approved or licensed for any use under section 505 of this Act or section 351 of the Public Health Service Act; (C) (i) for which an application has been filed under section 505(b) of this Act or section 351(a) of the Public Health Service Act; or (ii) that is under investigation in a clinical trial that— (I) is intended to form the primary basis of a claim of effectiveness in support of approval or licensure under section 505 of this Act or section 351 of the Public Health Service Act; and (II) is the subject of an active investigational new drug application under section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act, as applicable; and (D) the active development or production of which is ongoing and has not been discontinued by the manufacturer or placed on clinical hold under section 505(i); and (3) the term phase 1 trial means a phase 1 clinical investigation of a drug as described in section 312.21 of title 21, Code of Federal Regulations (or any successor regulations). (b) Exemptions Eligible investigational drugs provided to eligible patients in compliance with this section are exempt from sections 502(f), 503(b)(4), 505(a), and 505(i) of this Act, section 351(a) of the Public Health Service Act, and parts 50, 56, and 312 of title 21, Code of Federal Regulations (or any successor regulations), provided that the sponsor of such eligible investigational drug or any person who manufactures, distributes, prescribes, dispenses, introduces or delivers for introduction into interstate commerce, or provides to an eligible patient an eligible investigational drug pursuant to this section is in compliance with the applicable requirements set forth in sections 312.6, 312.7, and 312.8(d)(1) of title 21, Code of Federal Regulations (or any successor regulations) that apply to investigational drugs. (c) Use of clinical outcomes (1) In general Notwithstanding any other provision of this Act, the Public Health Service Act, or any other provision of Federal law, the Secretary may not use a clinical outcome associated with the use of an eligible investigational drug pursuant to this section to delay or adversely affect the review or approval of such drug under section 505 of this Act or section 351 of the Public Health Service Act unless— (A) the Secretary makes a determination, in accordance with paragraph (2), that use of such clinical outcome is critical to determining the safety of the eligible investigational drug; or (B) the sponsor requests use of such outcomes. (2) Limitation If the Secretary makes a determination under paragraph (1)(A), the Secretary shall provide written notice of such determination to the sponsor, including a public health justification for such determination, and such notice shall be made part of the administrative record. Such determination shall not be delegated below the director of the agency center that is charged with the premarket review of the eligible investigational drug. (d) Reporting (1) In general The manufacturer or sponsor of an eligible investigational drug shall submit to the Secretary an annual summary of any use of such drug under this section. The summary shall include the number of doses supplied, the number of patients treated, the uses for which the drug was made available, and any known serious adverse events. The Secretary shall specify by regulation the deadline of submission of such annual summary and may amend section 312.33 of title 21, Code of Federal Regulations (or any successor regulations) to require the submission of such annual summary in conjunction with the annual report for an applicable investigational new drug application for such drug. (2) Posting of information The Secretary shall post an annual summary report of the use of this section on the internet website of the Food and Drug Administration, including the number of drugs for which clinical outcomes associated with the use of an eligible investigational drug pursuant to this section was— (A) used in accordance with subsection (c)(1)(A); (B) used in accordance with subsection (c)(1)(B); and (C) not used in the review of an application under section 505 of this Act or section 351 of the Public Health Service Act. . (b) No Liability (1) Alleged acts or omissions With respect to any alleged act or omission with respect to an eligible investigational drug provided to an eligible patient pursuant to section 561B of the Federal Food, Drug, and Cosmetic Act and in compliance with such section, no liability in a cause of action shall lie against— (A) a sponsor or manufacturer; or (B) a prescriber, dispenser, or other individual entity (other than a sponsor or manufacturer), unless the relevant conduct constitutes reckless or willful misconduct, gross negligence, or an intentional tort under any applicable State law. (2) Determination not to provide drug No liability shall lie against a sponsor manufacturer, prescriber, dispenser or other individual entity for its determination not to provide access to an eligible investigational drug under section 561B of the Federal Food, Drug, and Cosmetic Act. (3) Limitation Except as set forth in paragraphs (1) and (2), nothing in this section shall be construed to modify or otherwise affect the right of any person to bring a private action under any State or Federal product liability, tort, consumer protection, or warranty law. 3. Sense of the Senate It is the sense of the Senate that section 561B of the Federal Food, Drug, and Cosmetic Act, as added by section 2— (1) does not establish a new entitlement or modify an existing entitlement, or otherwise establish a positive right to any party or individual; (2) does not establish any new mandates, directives, or additional regulations; (3) only expands the scope of individual liberty and agency among patients, in limited circumstances; (4) is consistent with, and will act as an alternative pathway alongside, existing expanded access policies of the Food and Drug Administration; (5) will not, and cannot, create a cure or effective therapy where none exists; (6) recognizes that the eligible terminally ill patient population often consists of those patients with the highest risk of mortality, and use of experimental treatments under the criteria and procedure described in such section 561A involves an informed assumption of risk; and (7) establishes national standards and rules by which investigational drugs may be provided to terminally ill patients.

Passed the Senate August 3, 2017. Julie E. Adams, Secretary

tv_txt: One Hundred Fifteenth Congress of the United States of America 2d Session Begun and held at the City of Washington on Wednesday, the third day of January, two thousand and eighteen S. 204 IN THE SENATE OF THE UNITED STATES AN ACT To authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes.

1. Short title This Act may be cited as the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 . 2. Use of unapproved investigational drugs by patients diagnosed with a terminal illness (a) In general Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 561A ( 21 U.S.C. 360bbb–0 ) the following: 561B. Investigational drugs for use by eligible patients (a) Definitions For purposes of this section— (1) the term eligible patient means a patient— (A) who has been diagnosed with a life-threatening disease or condition (as defined in section 312.81 of title 21, Code of Federal Regulations (or any successor regulations)); (B) who has exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug, as certified by a physician, who— (i) is in good standing with the physician’s licensing organization or board; and (ii) will not be compensated directly by the manufacturer for so certifying; and (C) who has provided to the treating physician written informed consent regarding the eligible investigational drug, or, as applicable, on whose behalf a legally authorized representative of the patient has provided such consent; (2) the term eligible investigational drug means an investigational drug (as such term is used in section 561)— (A) for which a Phase 1 clinical trial has been completed; (B) that has not been approved or licensed for any use under section 505 of this Act or section 351 of the Public Health Service Act; (C) (i) for which an application has been filed under section 505(b) of this Act or section 351(a) of the Public Health Service Act; or (ii) that is under investigation in a clinical trial that— (I) is intended to form the primary basis of a claim of effectiveness in support of approval or licensure under section 505 of this Act or section 351 of the Public Health Service Act; and (II) is the subject of an active investigational new drug application under section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act, as applicable; and (D) the active development or production of which is ongoing and has not been discontinued by the manufacturer or placed on clinical hold under section 505(i); and (3) the term phase 1 trial means a phase 1 clinical investigation of a drug as described in section 312.21 of title 21, Code of Federal Regulations (or any successor regulations). (b) Exemptions Eligible investigational drugs provided to eligible patients in compliance with this section are exempt from sections 502(f), 503(b)(4), 505(a), and 505(i) of this Act, section 351(a) of the Public Health Service Act, and parts 50, 56, and 312 of title 21, Code of Federal Regulations (or any successor regulations), provided that the sponsor of such eligible investigational drug or any person who manufactures, distributes, prescribes, dispenses, introduces or delivers for introduction into interstate commerce, or provides to an eligible patient an eligible investigational drug pursuant to this section is in compliance with the applicable requirements set forth in sections 312.6, 312.7, and 312.8(d)(1) of title 21, Code of Federal Regulations (or any successor regulations) that apply to investigational drugs. (c) Use of clinical outcomes (1) In general Notwithstanding any other provision of this Act, the Public Health Service Act, or any other provision of Federal law, the Secretary may not use a clinical outcome associated with the use of an eligible investigational drug pursuant to this section to delay or adversely affect the review or approval of such drug under section 505 of this Act or section 351 of the Public Health Service Act unless— (A) the Secretary makes a determination, in accordance with paragraph (2), that use of such clinical outcome is critical to determining the safety of the eligible investigational drug; or (B) the sponsor requests use of such outcomes. (2) Limitation If the Secretary makes a determination under paragraph (1)(A), the Secretary shall provide written notice of such determination to the sponsor, including a public health justification for such determination, and such notice shall be made part of the administrative record. Such determination shall not be delegated below the director of the agency center that is charged with the premarket review of the eligible investigational drug. (d) Reporting (1) In general The manufacturer or sponsor of an eligible investigational drug shall submit to the Secretary an annual summary of any use of such drug under this section. The summary shall include the number of doses supplied, the number of patients treated, the uses for which the drug was made available, and any known serious adverse events. The Secretary shall specify by regulation the deadline of submission of such annual summary and may amend section 312.33 of title 21, Code of Federal Regulations (or any successor regulations) to require the submission of such annual summary in conjunction with the annual report for an applicable investigational new drug application for such drug. (2) Posting of information The Secretary shall post an annual summary report of the use of this section on the internet website of the Food and Drug Administration, including the number of drugs for which clinical outcomes associated with the use of an eligible investigational drug pursuant to this section was— (A) used in accordance with subsection (c)(1)(A); (B) used in accordance with subsection (c)(1)(B); and (C) not used in the review of an application under section 505 of this Act or section 351 of the Public Health Service Act. . (b) No Liability (1) Alleged acts or omissions With respect to any alleged act or omission with respect to an eligible investigational drug provided to an eligible patient pursuant to section 561B of the Federal Food, Drug, and Cosmetic Act and in compliance with such section, no liability in a cause of action shall lie against— (A) a sponsor or manufacturer; or (B) a prescriber, dispenser, or other individual entity (other than a sponsor or manufacturer), unless the relevant conduct constitutes reckless or willful misconduct, gross negligence, or an intentional tort under any applicable State law. (2) Determination not to provide drug No liability shall lie against a sponsor manufacturer, prescriber, dispenser or other individual entity for its determination not to provide access to an eligible investigational drug under section 561B of the Federal Food, Drug, and Cosmetic Act. (3) Limitation Except as set forth in paragraphs (1) and (2), nothing in this section shall be construed to modify or otherwise affect the right of any person to bring a private action under any State or Federal product liability, tort, consumer protection, or warranty law. 3. Sense of the Senate It is the sense of the Senate that section 561B of the Federal Food, Drug, and Cosmetic Act, as added by section 2— (1) does not establish a new entitlement or modify an existing entitlement, or otherwise establish a positive right to any party or individual; (2) does not establish any new mandates, directives, or additional regulations; (3) only expands the scope of individual liberty and agency among patients, in limited circumstances; (4) is consistent with, and will act as an alternative pathway alongside, existing expanded access policies of the Food and Drug Administration; (5) will not, and cannot, create a cure or effective therapy where none exists; (6) recognizes that the eligible terminally ill patient population often consists of those patients with the highest risk of mortality, and use of experimental treatments under the criteria and procedure described in such section 561A involves an informed assumption of risk; and (7) establishes national standards and rules by which investigational drugs may be provided to terminally ill patients.

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