Bill Text

Bill Information

PDF |Add To My Favorites |Track Bill | print page

AB-617 Stem Cell Clinic Regulation Advisory Group.(2019-2020)

SHARE THIS:share this bill in Facebookshare this bill in Twitter
Date Published: 03/21/2019 09:00 PM
AB617:v98#DOCUMENT

Amended  IN  Assembly  March 21, 2019

CALIFORNIA LEGISLATURE— 2019–2020 REGULAR SESSION

Assembly Bill No. 617


Introduced by Assembly Member Mullin

February 14, 2019


An act to amend Section 684 of the Business and Professions Code, add Chapter 3 (commencing with Section 125360) to Part 5.5 of Division 106 of the Health and Safety Code, relating to healing arts. public health.


LEGISLATIVE COUNSEL'S DIGEST


AB 617, as amended, Mullin. Stem cell therapies notice. Stem Cell Clinic Regulation Advisory Group.
Existing law requires the State Department of Public Health to establish and maintain an anonymous registry of embryos that are available for research. Existing law makes it the policy of the state that research involving the derivation and use of human embryonic stem cells, human embryonic germ cells, and human adult stem cells shall be reviewed by a stem cell research oversight committee.
Existing federal law creates an electronic registration and listing system for establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) and to establish current good tissue practice and other procedures to prevent the introduction, transmission, and spread of communicable diseases by HCT/Ps. Existing federal law requires the federal Food and Drug Administration to register, list, and regulate HCT/Ps for these purposes.
This bill would require the department, no later than an unspecified date, to convene the Stem Cell Clinic Regulation Advisory Group for purposes of, among other duties, holding a series of stakeholder meetings to review current licensing and certification laws and the department’s procedures to determine whether those laws and procedures provide for adequate consumer protection for the use of stem cell therapies in clinics, and to make recommendations to the Legislature, on or before an unspecified date, regarding how to improve state oversight of clinics offering or providing stem cell therapies to patients.

Existing law provides for the licensure and regulation of various health care practitioners by various boards within the Department of Consumer Affairs. Existing law requires licensed health care practitioners who perform stem cell therapies that are subject to regulation by the United States Food and Drug Administration (FDA), but are not FDA-approved, to communicate to their patients specified information regarding the therapies in a notice and in writing prior to providing the initial stem cell therapy.

This bill would make nonsubstantive changes to that notice provision.

Vote: MAJORITY   Appropriation: NO   Fiscal Committee: NOYES   Local Program: NO  

The people of the State of California do enact as follows:


SECTION 1.

 Chapter 3 (commencing with Section 125360) is added to Part 5.5 of Division 106 of the Health and Safety Code, to read:
CHAPTER  3. Stem Cell Clinic Regulation Advisory Group

125360.
 For purposes of this chapter, the following definitions apply:
(a) “Clinic” has the meaning set forth in Section 1200.
(b) “Department” means the State Department of Public Health.
(c) “FDA” means the federal Food and Drug Administration.
(d) “HCT/Ps” means human cells, tissues, or cellular or tissue-based products, as defined in Section 1271.3 of Title 21 of the Code of Federal Regulations, as amended August 31, 2016, as published in the Federal Register (81 Fed. Reg. 60223).
(e) “Stem cell therapy” means a therapy involving the use of HCT/Ps.

125361.
 (a) No later than ____, the department shall convene the Stem Cell Clinic Regulation Advisory Group for purposes of holding a series of stakeholder meetings. The duties of the advisory group include all of the following:
(1) Review current licensing and certification laws and the department’s procedures to determine whether those laws and procedures provide for adequate consumer protection for the use of stem cell therapies in clinics.
(2) Make recommendations to the Legislature, on or before ____, regarding how to improve state oversight of clinics offering or providing stem cell therapies to patients.
(3) Adopt, if appropriate, emergency regulations to protect the public against stem cell therapies that are not in compliance with federal laws and regulations, including regulations adopted by the federal Food and Drug Administration. The department shall consult relevant stakeholders prior to promulgating regulations and shall provide a 90-day notice to stakeholders prior to adopting regulations. The adoption of these regulations is an emergency and necessary for the immediate preservation of the public peace, health and safety, or general welfare.
(b) In carrying out the duties described in subdivision (a), the department shall consult with the medical community, bioethicists, legal scholars, and patient advocacy groups. The department is authorized to consult with the California Institute for Regenerative Medicine.

SECTION 1.Section 684 of the Business and Professions Code is amended to read:
684.

(a)For the purpose of this section, the following terms have the following meanings:

(1)“FDA” means the United States Food and Drug Administration.

(2)“HCT/Ps” means human cells, tissues, or cellular or tissue-based products, as defined in Section 1271.3 of Title 21 of the Code of Federal Regulations, as amended August 31, 2016, as published in the Federal Register (81 Fed. Reg. 60223).

(3)“Stem cell therapy” means a therapy involving the use of HCT/Ps, but shall not include a therapy involving HCT/Ps that meets the criteria set out in Section 1271.10 of Title 21 of the Code of Federal Regulations, as amended May 25, 2004, as published in the Federal Register (69 Fed. Reg. 29829), or that qualifies for any of the exceptions described in Section 1271.15 of Title 21 of the Code of Federal Regulations, as amended May 25, 2004, as published in the Federal Register (69 Fed. Reg. 29829).

(b)(1)A health care practitioner licensed under this division who performs a stem cell therapy that is subject to FDA regulation, but is not FDA-approved, shall communicate to a patient seeking stem cell therapy the following information in English:


“THIS NOTICE MUST BE PROVIDED TO YOU UNDER CALIFORNIA LAW. This health care practitioner performs one or more stem cell therapies that have not been approved by the United States Food and Drug Administration. You are encouraged to consult with your primary care physician prior to undergoing a stem cell therapy.”


(2)The information in paragraph (1) shall be communicated to the patient in all of the following ways:

(A)In a prominent display in an area visible to patients in the health care practitioner’s office and posted conspicuously in the entrance of the health care practitioner’s office. These notices shall be at least eight and one-half inches by 11 inches and written in no less than 40-point type.

(B)Prior to providing the initial stem cell therapy, a health care practitioner shall provide the patient with the notice described in paragraph (1) in writing. The notice shall be at least eight and one-half inches by 11 inches and written in no less than 40-point type.

(c)This section does not apply to a health care practitioner licensed under this division who has obtained approval or clearance for an investigational new drug, or an investigational device exemption, from the FDA for the use of HCT/Ps.

(d)(1)The licensing board having jurisdiction of the health care practitioner may cite and fine the health care practitioner, not to exceed one thousand dollars ($1,000) per violation of this section.

(2)No citation shall be issued and no fine shall be assessed upon the first complaint against a health care practitioner who violates this section.

(3)Upon a second or subsequent violation of this section, a citation and administrative fine not to exceed one thousand dollars ($1,000) per violation may be assessed.

(e)The Medical Board of California shall indicate in its annual report, commencing with the 2018–19 annual report, all of the following with regard to licensees who provide stem cell therapies:

(1)The number of complaints received.

(2)Any disciplinary actions taken.

(3)Any administrative actions taken.