Stem-Cell Clinics Under Fire

April 11, 2019 | Cassandra Rivais DiNova | FDA | Fraud and Abuse | Litigation

On April 3, the U.S. Food and Drug Administration (FDA) sent warning letters to about 20 stem-cell clinics notifying them that their activities appear to require FDA approval. The letters, similar in form to this one, cited guidance materials that clinics can use as resources in becoming compliant with FDA requirements.

Stem-cell therapy involves removing a person’s stem cells and injecting them back into the body after some manipulation. Most insurance companies do not cover the cost of this treatment as the therapies remain unapproved. The FDA is concerned that stem-cell clinics are marketing unapproved treatments that may harm patients, as adverse side effects have been reported in many cases.

In a statement, the FDA pointed out that it is nearly halfway through a three-year period since its release of November 2017 guidance. At the end of the period, in November 2020, the agency plans to increase its regulatory enforcement activities. The FDA has gone after stem-cell clinics before, as in May 2018 when it sought permanent injunctions against two clinics.

New York stem-cell clinics face further scrutiny from the State Attorney General, who on April 3 filed a lawsuit against Park Avenue Stem Cell for allegedly engaging in fraudulent and illegal advertising regarding its procedures. The clinic was representing to patients, without scientific substantiation, that a variety of serious medical conditions could be treated with their own stem cells.

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