Lancaster Municipal Code Ch. 8.80 Age Based Right to Try Ordinance

This chapter shall be known and may be cited as the "City of Lancaster Age Based Right to Try Ordinance."

(Ord. No. 1132, § 2(Exh. A), 6-10-2025)

For purposes of this chapter, the following definitions apply:

"City." The City of Lancaster, California.

"Eligible individual." An individual who meets at least one of the following criteria: (i) has a serious life-threatening illness, defined as a disease or condition that, without life-sustaining procedures, will result in death or permanent unconsciousness, as certified by a licensed physician, has considered all FDA-approved treatment options, is unable to participate in a clinical trial within fifty (50) miles of their home, and has provided written informed consent; and (ii) is seventy (70) years of age or older, has decision making capacity as certified by a licensed physician, has a condition for which FDA-approved treatments are deemed insufficient by a licensed physician, and has provided written informed consent.

"FDA" means the United States Food and Drug Administration.

"Informed consent" means written informed consent meeting the standards set forth in Health & Safety Code section 111548.1(h)(1).

"Investigational therapy" means a drug, biological product, or device for which the sponsor has filed an investigational new drug (IND) or investigational device exemption (IDE) application with the FDA and has completed a Phase I clinical trial approved by the FDA.

"Licensed medical facility" means any hospital, clinic, or health care facility located within the City of Lancaster that holds a valid California license to administer prescription drugs or biological products.

"Manufacturer" means an entity that produces or prepares an investigational therapy.

"Physician" means a person licensed to practice medicine in the State of California and in good standing under California law.

(Ord. No. 1132, § 2(Exh. A), 6-10-2025)

An eligible individual may enroll in an investigational therapy at a licensed medical facility only if:

A. The individual is aged seventy (70) or older.

B. A physician certifies in writing that the individual has decision making capacity and voluntarily elects to pursue an investigational therapy.

C. The individual executes an informed consent document compliant with California Health & Safety Code § 111548 et seq.

D. All administration, monitoring, and follow up occur at a licensed medical facility within the City of Lancaster.

(Ord. No. 1132, § 2(Exh. A), 6-10-2025)

A. Physician Responsibilities. The attending physician must:

1. Obtain the eligible individual's informed consent on a form that clearly explains known and potential risks, benefits, and alternatives; and

2. Provide a statement that the therapy is investigational and that its safety and efficacy are not yet fully established; and

3. Provide written certification of patient eligibility;

4. Ensure all treatment is conducted at a licensed medical facility.

B. Manufacturer Responsibilities. The manufacturer shall provide the attending physician at the licensed medical facility with:

1. Documentation of Phase I trial completion;

2. Known safety and risk information; and

3. A declaration of compliance with all applicable federal requirements.

C. Record Keeping. The physician, manufacturer, and licensed medical facility shall each preserve all certifications, consents, and administration records for at least seven years and make them available for inspection by the city upon request.

(Ord. No. 1132, § 2(Exh. A), 6-10-2025)

No official, employee, or agent of the City of Lancaster—shall prohibit, penalize, interfere with, or otherwise restrict an eligible individual's access to an investigational therapy under this chapter, provided all requirements of this chapter are met.

(Ord. No. 1132, § 2(Exh. A), 6-10-2025)

This chapter does not create a private cause of action, and actions taken pursuant to this chapter shall not serve as a basis for a civil, criminal, or disciplinary claim or cause of action, including, but not limited to, product liability, medical negligence, or wrongful death, 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 for harm done to the eligible patient or his or her heirs resulting from the investigational drug, biological product, or device, or the use or nonuse thereof, if the manufacturer or other person or entity has complied with the terms of this article in relation to the eligible patient, unless there was willful misconduct or gross negligence.

(Ord. No. 1132, § 2(Exh. A), 6-10-2025)

A. To the extent any provision of this chapter conflicts with California Health & Safety Code § 111548 et seq., the state statute shall prevail; this chapter shall be construed to afford rights and immunities at least equal to those provided by state law.

B. Nothing herein is intended to expand or diminish any right conferred by state or federal law beyond what is expressly authorized by California Health & Safety Code § 111548 et seq.

(Ord. No. 1132, § 2(Exh. A), 6-10-2025)