Bill Text: TX HB638 | 2023-2024 | 88th Legislature | Comm Sub
Bill Title: Relating to access to certain investigational drugs, biological products, and devices used in clinical trials by patients with severe chronic diseases.
Spectrum: Moderate Partisan Bill (Republican 4-1)
Status: (Introduced - Dead) 2023-05-11 - Laid on the table subject to call [HB638 Detail]
Download: Texas-2023-HB638-Comm_Sub.html
| 88R23538 KKR-F | |||
| By: Toth, Burrows, Harris of Anderson, | H.B. No. 638 | ||
| Bonnen | |||
| Substitute the following for H.B. No. 638: | |||
| By: Klick | C.S.H.B. No. 638 | ||
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| relating to access to certain investigational drugs, biological | ||
| products, and devices used in clinical trials by patients with | ||
| severe chronic diseases. | ||
| BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: | ||
| SECTION 1. (a) This Act shall be known as Mary Lou's Law. | ||
| (b) The legislature finds that: | ||
| (1) the Right To Try Act, as added by Chapter 502 (H.B. | ||
| 21), Acts of the 84th Legislature, Regular Session, 2015, has had | ||
| tremendous success in saving the lives of many patients with a | ||
| terminal illness; | ||
| (2) the process for approving the use of | ||
| investigational drugs, biological products, and devices by | ||
| patients without a terminal illness who need access to the drugs, | ||
| products, or devices takes many years in the United States; | ||
| (3) patients who are battling a severe chronic disease | ||
| that is debilitating or causes severe pain do not have the luxury of | ||
| waiting until the United States Food and Drug Administration gives | ||
| final approval for an investigational drug, biological product, or | ||
| device; | ||
| (4) the United States Food and Drug Administration | ||
| standards for the use of investigational drugs, biological | ||
| products, and devices may deny the benefits of potentially | ||
| life-altering treatment to patients with a severe chronic disease; | ||
| (5) patients with a severe chronic disease have a | ||
| fundamental right to pursue the preservation of their state of life | ||
| by accessing available investigational drugs, biological products, | ||
| and devices; | ||
| (6) the use of available investigational drugs, | ||
| biological products, and devices is a decision that a patient with a | ||
| severe chronic disease should make in consultation with the | ||
| patient's physician and is not a decision the government should | ||
| make; and | ||
| (7) the decision to use an investigational drug, | ||
| biological product, or device should be made with full awareness of | ||
| the potential risks, benefits, and consequences to a patient with a | ||
| severe chronic disease and the patient's family. | ||
| (c) It is the intent of the legislature to allow patients | ||
| with a severe chronic disease to use potentially life-altering | ||
| investigational drugs, biological products, and devices. | ||
| SECTION 2. Subtitle C, Title 6, Health and Safety Code, is | ||
| amended by adding Chapter 490 to read as follows: | ||
| CHAPTER 490. ACCESS TO INVESTIGATIONAL TREATMENTS FOR PATIENTS | ||
| WITH SEVERE CHRONIC DISEASES | ||
| SUBCHAPTER A. GENERAL PROVISIONS | ||
| Sec. 490.001. DEFINITIONS. In this chapter: | ||
| (1) "Commissioner" means the commissioner of state | ||
| health services. | ||
| (2) "Executive commissioner" means the executive | ||
| commissioner of the Health and Human Services Commission. | ||
| (3) "Investigational drug, biological product, or | ||
| device" means a drug, biological product, or device that has | ||
| successfully completed phase one of a clinical trial but has not yet | ||
| been approved for general use by the United States Food and Drug | ||
| Administration or its international equivalent and that remains | ||
| under investigation in the clinical trial. The term does not | ||
| include low-THC cannabis, as defined by Section 169.001, | ||
| Occupations Code, or a product containing marihuana, as defined by | ||
| Section 481.002, regardless of whether the cannabis or product | ||
| successfully completed phase one of a clinical trial. | ||
| (4) "Severe chronic disease" means a condition, | ||
| injury, or illness that: | ||
| (A) may be treated; | ||
| (B) may not be cured or eliminated; and | ||
| (C) entails significant functional impairment or | ||
| severe pain. | ||
| Sec. 490.002. DESIGNATION OF SEVERE CHRONIC DISEASES. The | ||
| commissioner shall designate the medical conditions considered to | ||
| be severe chronic diseases under this chapter. | ||
| Sec. 490.003. RULES. The executive commissioner shall | ||
| adopt rules necessary to administer this chapter. | ||
| SUBCHAPTER B. ACCESS TO INVESTIGATIONAL DRUGS, BIOLOGICAL | ||
| PRODUCTS, AND DEVICES FOR PATIENTS WITH SEVERE CHRONIC DISEASES | ||
| Sec. 490.051. PATIENT ELIGIBILITY. A patient is eligible | ||
| to access and use an investigational drug, biological product, or | ||
| device under this chapter if: | ||
| (1) the patient has a severe chronic disease the | ||
| commissioner designates under Section 490.002 that the patient's | ||
| treating physician confirms in writing; | ||
| (2) the use of the investigational drug, biological | ||
| product, or device is consistent with this chapter and rules | ||
| adopted under this chapter; and | ||
| (3) the patient's physician: | ||
| (A) in consultation with the patient, considers | ||
| all other treatment options the United States Food and Drug | ||
| Administration has currently approved and determines those | ||
| treatment options are unavailable or unlikely to provide relief for | ||
| the significant impairment or severe pain associated with the | ||
| patient's severe chronic disease; and | ||
| (B) recommends or prescribes in writing the | ||
| patient's use of a specific class of investigational drug, | ||
| biological product, or device. | ||
| Sec. 490.052. INFORMED CONSENT. (a) A physician may | ||
| recommend or prescribe an investigational drug, biological | ||
| product, or device, only to an eligible patient who signs a written | ||
| informed consent. If the patient is a minor or lacks the mental | ||
| capacity to provide informed consent, a parent, guardian, or | ||
| conservator may provide informed consent on the patient's behalf. | ||
| (b) The commissioner may prescribe a form for the informed | ||
| consent required under this section. | ||
| Sec. 490.053. CAUSE OF ACTION NOT CREATED. This chapter | ||
| does not create a private or state cause of action against a | ||
| manufacturer of an investigational drug, biological product, or | ||
| device or against any other person or entity involved in the care of | ||
| an eligible patient using the investigational drug, biological | ||
| product, or device for any harm to the patient resulting from the | ||
| investigational drug, biological product, or device. | ||
| Sec. 490.054. STATE MAY NOT INTERFERE WITH ACCESS TO | ||
| INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, OR DEVICE. An official, | ||
| employee, or agent of this state may not prevent or attempt to | ||
| prevent an eligible patient's access to an investigational drug, | ||
| biological product, or device under this chapter unless the drug, | ||
| biological product, or device is considered adulterated or | ||
| misbranded under Chapter 431. For purposes of this section, a | ||
| governmental entity may not consider the drug, biological product, | ||
| or device to be adulterated or misbranded based solely on the United | ||
| States Food and Drug Administration not yet finally approving the | ||
| drug, biological product, or device. | ||
| SUBCHAPTER C. HEALTH INSURANCE | ||
| Sec. 490.101. EFFECT ON HEALTH CARE COVERAGE FOR CLINICAL | ||
| TRIAL ENROLLEES. This chapter does not affect the coverage of | ||
| enrollees in clinical trials under Chapter 1379, Insurance Code. | ||
| SUBCHAPTER D. PHYSICIANS | ||
| Sec. 490.151. ACTION AGAINST PHYSICIAN'S LICENSE | ||
| PROHIBITED. Notwithstanding any other law, the Texas Medical Board | ||
| may not revoke, fail to renew, suspend, or take any action against | ||
| a physician's license under Subchapter B, Chapter 164, Occupations | ||
| Code, based solely on the physician's recommendations to an | ||
| eligible patient regarding access to or treatment with an | ||
| investigational drug, biological product, or device, provided that | ||
| the recommendations meet the requirements of this chapter and rules | ||
| adopted under this chapter. | ||
| SECTION 3. (a) As soon as practicable after the effective | ||
| date of this Act, the commissioner of state health services shall | ||
| designate the medical conditions considered to be severe chronic | ||
| diseases as required by Section 490.002, Health and Safety Code, as | ||
| added by this Act. | ||
| (b) As soon as practicable after the effective date of this | ||
| Act, the executive commissioner of the Health and Human Services | ||
| Commission shall adopt the rules required by Section 490.003, | ||
| Health and Safety Code, as added by this Act. The executive | ||
| commissioner may adopt initial rules in the manner provided by law | ||
| for emergency rules. | ||
| SECTION 4. This Act takes effect immediately if it receives | ||
| a vote of two-thirds of all the members elected to each house, as | ||
| provided by Section 39, Article III, Texas Constitution. If this | ||
| Act does not receive the vote necessary for immediate effect, this | ||
| Act takes effect September 1, 2023. | ||
