Second Proposed Stem Cell Bill Goes to Florida House of Representatives

stem cell billBy: Matt Fischer

On November 29, 2018, Florida Representative Chuck Clemons proposed house bill 65 (“HB 65”) that would significantly tighten regulation on the use of stem cells.  If the stem cell bill is signed into law, Florida will join other states (e.g. California, Texas and Washington) in passing some type of stem cell regulation.  While some bills around the country have centered the regulation on informing prospective customers of the risks associated with these treatments, HB 65 takes a more stringent approach with the threat of criminal exposure and includes certain protections for providers in the form of a “right-to-try” law.

Some of the highlights of HB 65 include:Continue reading

I Want to Start a Stem Cell Distribution Business…Now What?

By: Matthew Fischer

Jumping into the stem cell industry can be an exciting venture.  However, with this emerging industry comes a mine field of legal pitfalls and potential problems.  The keys to a successful business not only include selecting a strong product and building strong relationships with clients but being able to navigate the regulatory framework that accompanies this type of product.

FDA regulations require establishments that perform one or more steps in the manufacturing process of HCT/Ps (i.e. Human Cells, Tissues, and Cellular and Tissue-Based Products) to register and submit a list of products with the agency.  If so, you have five days to register after beginning operations.  When I mention “manufacturing” to clients they usually interject with “I only want to distribute.”  Good point.  However, the FDA defines “manufacture” as any or all steps in the recovery, processing, storage, labeling, packaging, or distribution of any human cell or tissue.  These registrations must be updated annually and in the event of a change of ownership, within 30 days of the change. Continue reading

FDA Stem Cell Clinic Legal Issues: Stepped Up Enforcement

healthcare regulatory compliance audit

By: Matthew Fischer

With the rapid growth of the regenerative medicine field, the U.S. Food and Drug Administration (FDA) is trying to strike the right balance between preventing harm to the public and fostering innovation of new treatments.  In an effort to prevent potential harm, the FDA stepped up enforcement this week.  In two complaints filed by the U.S. Department of Justice (DOJ) on behalf of the FDA, the FDA has sought permanent injunctions against a California and Florida stem cell clinic along with their owners and officers to prevent the marketing of stem cell products without FDA approval and for failure to correct deviations from manufacturing practice requirements.Continue reading

New State Stem Cell Laws: A Brief Overview

stem cell law

By: Matthew Fischer

Amid the growing focus on stem cell products by the Federal Food and Drug Administration (FDA), multiple states have proposed and passed some form of stem cell law or clinic regulation.  While some center the regulation on informing prospective customers of the risks associated with these treatments others seek to protect the availability of these treatments in the form of a “right-to-try” law.  Here are a few examples:

California

Effective January of this year, California implemented a new regulation in its Business and Professions Code aimed at clinics offering non-FDA approved stem cell treatments.  The regulation requires a notice to be posted at the clinic entrance along with the requirement to provide a separate written notice to the patient prior to initiating treatment.  However, this requirement does not apply if a licensed health care practitioner has obtained approval for an investigational new drug from the FDA. Continue reading