On 12 March, a day before a vote in the U.S. House of Representatives on 'Right to Try' legislation, the ISSCR wrote a letter to House leadership expressing opposition to the measure, which would have allowed patients access to experimental medical treatments without FDA oversight and approval. The measure was narrowly defeated 13 March.

The ISSCR commends the U.S. Food and Drug Administration (FDA) for reaffirming its regulatory authority over stem cell biologics and clarifying the criteria that determine which cell-based products fall under its oversight. These guidance documents will provide greater transparency for patients, medical professionals, and law enforcement authorities, about the legal status of stem cell treatments in the U.S.

The ISSCR commends the U.S. Food and Drug Administration (FDA) for its policy direction and enforcement efforts, announced today, to provide “bright lines and appropriate oversight” when regulating stem cell treatments and regenerative medicine. The agency reported its enforcement actions against clinics in California and Florida offering unproven stem cell therapies, and announced pending policy and regulatory efforts against these practices.