BILL ANALYSIS

S.B. 670

By: Hughes

Public Health

Committee Report (Unamended)

BACKGROUND AND PURPOSE

The bill sponsor has informed the committee that consumers in other countries, such as those in the European Union (EU), have access to more effective sunscreens because, while the EU classifies sunscreen as a cosmetic product, the FDA considers sunscreen a drug, which requires more stringent testing. The bill sponsor has further informed the committee that current FDA regulations add unnecessary bureaucracy and cost while blocking Americans' access to higher-performance sunscreen ingredients. S.B. 670 seeks to address this issue by allowing patients to access investigational sun protection products that have not yet received full approval from the FDA and setting out the conditions under which patients may access these products, emphasizing patient autonomy and informed consent.

CRIMINAL JUSTICE IMPACT

It is the committee's opinion that this bill does not expressly create a criminal offense, increase the punishment for an existing criminal offense or category of offenses, or change the eligibility of a person for community supervision, parole, or mandatory supervision.

RULEMAKING AUTHORITY

It is the committee's opinion that rulemaking authority is expressly granted to the Texas Medical Board in SECTION 2 of this bill.

ANALYSIS

S.B. 670 amends the Health and Safety Code to require a physician, before recommending or prescribing an investigational sun protection product, to require an eligible patient to sign a written informed consent form. If the patient is a minor or lacks the mental capacity to provide informed consent, a parent or legal guardian may provide informed consent on the patient's behalf. The bill authorizes the Texas Medical Board (TMB) by rule to adopt a form for the required informed consent. The bill makes a patient who meets the following criteria eligible to access and use an investigational sun protection product:

· the patient's physician, in consultation with the patient, has considered all other sun protection products currently approved by the FDA and determined those products are less effective in comparison to an investigational sun protection product; and

· the patient's physician recommends or prescribes in writing an investigational sun protection product for the patient.

S.B. 670 authorizes a manufacturer of an investigational sun protection product to make available in accordance with the bill's provisions and any rules adopted under those provisions the manufacturer's product to eligible patients who provide to the manufacturer the required informed consent. The bill expressly does not require a manufacturer to make available an investigational sun protection product to an eligible patient. The bill authorizes the manufacturer to do the following:

· provide an investigational sun protection product to an eligible patient without receiving compensation; or

· require an eligible patient to pay the manufacturer's costs of, or costs associated with, the manufacture of the product.

The bill expressly does not create a private or state cause of action against a manufacturer of an investigational sun protection product or against any other person or entity involved in the care of an eligible patient using the product for any harm to the eligible patient resulting from the product. The bill prohibits an official, employee, or agent of the state from blocking or attempting to block an eligible patient's access to an investigational sun protection product under the bill's provisions. The bill defines "investigational sun protection product" as a sun protection product containing an ingredient that has successfully completed phase one of a clinical trial but has not yet been approved for general use by the FDA and remains under investigation in the clinical trial.

S.B. 670 establishes that its provisions do not affect the coverage of certain health benefit plan enrollees in clinical trials under applicable Insurance Code provisions.

S.B. 670 prohibits the TMB from revoking, failing to renew, suspending, or taking any action against a physician's license under provisions of the Medical Practice Act relating to disciplinary actions based solely on the physician's recommendation to or prescription for an eligible patient regarding access to an investigational sun protection product, provided the recommendation or prescription for the patient meets the medical standard of care and the bill's requirements.

S.B. 670 sets out the following legislative findings:

· the process for the approval of investigational sun protection products in the United States takes many years;

· some patients do not have the luxury of waiting until an investigational sun protection product receives final approval from the FDA;

· the FDA standards for the use of investigational sun protection products may deny patients the benefits of potentially life-saving products;

· patients have a fundamental right to attempt to preserve their health and lives by accessing available investigational sun protection products;

· the use of available investigational sun protection products is a decision the patient in consultation with the patient's physician should make to preserve the patient's health or life and is not a decision the government should make; and

· the decision to use an investigational sun protection product should be made with full awareness of the potential risks, benefits, and consequences to the patient.

The bill establishes that it is the intent of the legislature to allow patients the option of using investigational sun protection products.

EFFECTIVE DATE

On passage, or, if the bill does not receive the necessary vote, September 1, 2025.