HOUSE BILL REPORT

ESHB 2356

This analysis was prepared by non-partisan legislative staff for the use of legislative members in their deliberations. This analysis is not a part of the legislation nor does it constitute a statement of legislative intent.

As Passed House:

February 12, 2018

Title: An act relating to stem cell therapies not approved by the United States food and drug administration.

Brief Description: Concerning stem cell therapies not approved by the United States food and drug administration.

Sponsors: House Committee on Health Care & Wellness (originally sponsored by Representatives Cody, Johnson, McBride, Jinkins, Ryu and Ormsby).

Brief History:

Committee Activity:

Health Care & Wellness: 1/12/18, 1/17/18 [DPS].

Floor Activity:

Passed House: 2/12/18, 97-0.

Brief Summary of Engrossed Substitute Bill

  • Requires licensed healthcare providers who perform therapies using human cells, tissues, or cellular or tissue-based products that have not been approved by the United States Food and Drug Administration (FDA) to provide notification that the therapy has not been approved by the FDA and to obtain the patient's written informed consent before performing the therapy.

HOUSE COMMITTEE ON HEALTH CARE & WELLNESS

Majority Report: The substitute bill be substituted therefor and the substitute bill do pass. Signed by 17 members: Representatives Cody, Chair; Macri, Vice Chair; Schmick, Ranking Minority Member; Graves, Assistant Ranking Minority Member; Caldier, Clibborn, DeBolt, Harris, Jinkins, MacEwen, Maycumber, Riccelli, Robinson, Rodne, Slatter, Stonier and Tharinger.

Staff: Nate Hickner (786-7291) and Jim Morishima (786-7191).

Background:

Stem Cell Therapies.

A stem-cell is a type of cell in a living organism that has the potential to split into a variety of different types of cells. Sometimes referred to as "master cells," stem cells can give rise to specialized cells such as blood, brain, or nerve cells, while themselves remaining stem cells.

The only stem cell-based products that are approved by the United States Food and Drug Administration (FDA) for use in the United States consist of blood-forming stem cells (hematopoietic progenitor cells) derived from cord blood. These products are approved for limited use in patients with disorders affecting the body's blood production systems.

Food and Drug Administration Regulation and Exceptions.

The FDA regulates the use of human cells, tissues, and cellular or tissue-based products (HCT/Ps), a category that includes, among other things, bone, skin, heart valves, semen, and stem cells. The FDA takes a tiered, risk-based approach to HCT/P regulation, with different requirements adhering to different sorts of HCT/Ps. As a general rule, HCT/P products are regulated as drugs, and are therefore subject to pre-market FDA clearance and approval and other requirements. However, the regulations provide for two exceptions to the pre-market approval (and in some cases, other) requirements:

Exception 1: The "Same Surgical Procedure" Exception.

The FDA excludes from regulation (including pre-market approval and clearance requirements) a number of categories of HCT/P users including:

Exception 2: The "Minimally Manipulated" Exception.

The FDA excludes from the pre-market approval and clearance requirement, but imposes other, less stringent requirements on HCT/P users when:

Food and Drug Administration Guidance and Enforcement Timeline.

The FDA has recently communicated its intention to pursue enforcement actions against providers of stem cell therapies that it views as abusing the above-listed exceptions. In November 2017 the FDA issued two guidance documents discussing the FDA's interpretation of terms within these exceptions.

In order to allow manufacturers of products time to comply with these requirements, until November 2020, the FDA intends to pursue enforcement action only against those noncompliant HCT/P procedures that raise reported or potential significant safety concerns.

Uniform Disciplinary Act.

Credentialed health care providers are subject to professional discipline under the Uniform Disciplinary Act (UDA). Under the UDA, the disciplining authority may take action against a provider for a variety of reasons, including unprofessional conduct, unlicensed practice, and the mental or physical inability to practice skillfully or safely. The Department of Health is the disciplining authority for many providers, and various boards and commissions are the disciplining authority for the remainder.

Upon a finding of unprofessional conduct, the disciplining authority may order sanctions such as revocation of the license, fines, compliance with probation conditions, or restriction or limitation of the practice.

Summary of Engrossed Substitute Bill:

A credentialed health care provider who performs a therapy using HCT/Ps not approved by the FDA must satisfy the following notice and written informed consent requirements prior to performing the therapy.

Notice.

The notice must read as follows:

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

The notice must be provided:

Written Consent.

The credentialed health care provider is also required to obtain a signed consent form before performing the therapy. The consent form must be signed by the patient, or, if the patient is legally not competent, the patient's representative, and must state, in language the patient could reasonably be expected to understand:

Violation of these requirements constitutes unprofessional conduct under the UDA.

These requirements do not apply to:

Appropriation: None.

Fiscal Note: Available.

Effective Date: The bill takes effect 90 days after adjournment of the session in which the bill is passed.

Staff Summary of Public Testimony:

(In support) Stem-cell medicine holds tremendous promise. But at the moment, the only real legitimate uses of stem-cells in clinical therapies are for use in the blood-forming system. Everything else should be considered experimental or some form of chicanery. There has been a burgeoning industry of stem-cell clinics that have popped up in the United States, but there is little evidence underlying the promises of most of these clinics—they claim to treat erectile dysfunction, autism, etc., but there is no plausible basis for these claims. For some of these clinics, it boils down to an outrageous abuse of vulnerable people looking for solutions to difficult problems.

The FDA has expressed concern about this. There have been instances not only of people being defrauded, but also instances of patient harm. The FDA is on a three-year program to crack down on these clinics, but the federal ability to enforce is limited. It is important for states to step up. A bill on this topic in California has already been passed. If Washington passed this we would be the second to regulate in this area, and we would be on the leading edge of a necessary curve.

The public needs to be protected from this type of activity. Not only is it harmful to individuals that participate in these treatments, but the practice also has a wider impact, threatening the integrity of what is otherwise an immensely promising field.

(Opposed) None.

Persons Testifying: Chuck Murry and Anthony Blau, University of Washington School of Medicine.

Persons Signed In To Testify But Not Testifying: None.