House File 2203 - Introduced HOUSE FILE 2203 BY COMMITTEE ON HUMAN RESOURCES (SUCCESSOR TO HF 2010) A BILL FOR An Act relating to experimental treatments for terminally ill 1 persons, and including effective date provisions. 2 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 3 TLSB 5457HV (3) 89 pf/rh

H.F. 2203 Section 1. Section 144E.2, subsection 1, paragraphs a, c, 1 and e, Code 2022, are amended to read as follows: 2 a. Has a terminal illness, attested to by the patient’s a 3 treating physician , or is receiving mechanical ventilation to 4 prolong life . 5 c. Has received a recommendation from the individual’s a 6 physician for an investigational drug, biological product, or 7 device. 8 e. Has documentation from the individual’s a physician that 9 the individual meets the requirements of this subsection . 10 Sec. 2. Section 144E.2, subsection 2, Code 2022, is amended 11 to read as follows: 12 2. “Investigational drug, biological product, or device” 13 means a any of the following: 14 a. A drug, biological product, or device that has 15 successfully completed phase 1 of a United States food and drug 16 administration-approved clinical trial but has not yet been 17 approved for general use by the United States food and drug 18 administration and remains under investigation in a United 19 States food and drug administration-approved clinical trial. 20 b. An off-label use of a drug. 21 Sec. 3. Section 144E.2, Code 2022, is amended by adding the 22 following new subsection: 23 NEW SUBSECTION . 2A. “Off-label use of a drug” means 24 the legal, prescribed use of a drug in a manner different 25 from that described on the United States food and drug 26 administration-approved drug label, including the use of a 27 drug for a different disease or medical condition or giving 28 a drug at a different dose or through a different route of 29 administration other than that approved by the United States 30 food and drug administration. 31 Sec. 4. Section 144E.2, subsection 4, unnumbered paragraph 32 1, Code 2022, is amended to read as follows: 33 “Written informed consent” means a written document that 34 is signed by the patient, a parent of a minor patient, or a 35 -1- LSB 5457HV (3) 89 pf/rh 1/ 3

H.F. 2203 legal guardian or other legal representative of the patient and 1 attested to by the patient’s a treating physician and a witness 2 and that includes all of the following: 3 Sec. 5. Section 144E.2, subsection 4, paragraphs b and d, 4 Code 2022, are amended to read as follows: 5 b. An attestation that the patient concurs with the 6 patient’s a treating physician in believing that all products 7 and treatments approved by the United States food and drug 8 administration are unlikely to prolong the patient’s life. 9 d. A description of the best and worst potential outcomes 10 of using the investigational drug, biological product, or 11 device and a realistic description of the most likely outcome. 12 The description shall include the possibility that new, 13 unanticipated, different, or worse symptoms might result 14 and that death could be hastened by use of the proposed 15 investigational drug, biological product, or device. The 16 description shall be based on the a treating physician’s 17 knowledge of the proposed investigational drug, biological 18 product, or device in conjunction with an awareness of the 19 patient’s condition. 20 Sec. 6. Section 144E.8, subsection 1, Code 2022, is amended 21 to read as follows: 22 1. This chapter shall not create a private cause of 23 action against a manufacturer of an investigational drug, 24 biological product, or device , against a physician, health care 25 practitioner, or facility that provides necessary follow-up 26 care, or against any other person or entity involved in the 27 care of an eligible patient using the investigational drug, 28 biological product, or device for any harm done to the eligible 29 patient resulting from the investigational drug, biological 30 product, or device, if the manufacturer or other person or 31 entity is complying in good faith with the terms of this 32 chapter and has exercised reasonable care. 33 Sec. 7. Section 144E.9, Code 2022, is amended to read as 34 follows: 35 -2- LSB 5457HV (3) 89 pf/rh 2/ 3

H.F. 2203 144E.9 Assisting suicide. 1 This chapter shall not be construed to allow a patient’s 2 treating physician to assist the a patient in committing or 3 attempting to commit suicide as prohibited in section 707A.2 . 4 Sec. 8. EFFECTIVE DATE. This Act, being deemed of immediate 5 importance, takes effect upon enactment. 6 EXPLANATION 7 The inclusion of this explanation does not constitute agreement with 8 the explanation’s substance by the members of the general assembly. 9 This bill relates to experimental treatments for terminally 10 ill persons. 11 The bill expands the definition of “eligible patient” to 12 include a person who is receiving mechanical ventilation to 13 prolong life. The bill also expands the definition of an 14 “investigational drug, biological product, or device” to 15 include the off-label use of a drug as defined in the bill. 16 The bill replaces the current required involvement of the 17 patient’s physician or the patient’s treating physician to 18 instead require involvement from a physician or a treating 19 physician to fulfill certain duties. The bill expands 20 protections relating to a private cause of action for certain 21 persons complying in good faith with and exercising reasonable 22 care under the bill. 23 The bill takes effect upon enactment. 24 -3- LSB 5457HV (3) 89 pf/rh 3/ 3