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