NEW YORK – The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) on Thursday warned that unregulated advanced therapy medicinal products, including certain dendritic cell therapies, could put patients at risk.
In a notice posted on the EMA's website, the agency said individuals, companies, and clinics are marketing advanced medicines directly to patients without oversight or evidence of safety and efficacy. The types of unregulated products the EMA is concerned about include therapies comprising genes, tissues, or cells, which, according to the agency, may cause serious side effects in patients due to contamination, inconsistent product composition, or deterioration from improper storage conditions and lack of manufacturing compliance.
European authorities are investigating suppliers of such unregulated advanced therapies and are encouraging the public to contact the EMA and report any suspicious products, which are often sold through websites and social media. Some signs that a product is unregulated and may be illegal include: The product is marketed as experimental but is offered outside of an authorized clinical trial; the provider cannot confirm the product is authorized; or the product's claimed benefits are superior to those of currently authorized treatments, but the claims are not supported by data in the medical literature.
People seeking access to advanced therapies, including dendritic cell therapy, are encouraged to discuss their options with a doctor. If they are offered such treatments, patients should confirm the product is authorized or approved by a regulatory agency. The EMA and HMA also encourage patients to also seek a second opinion when considering these therapies.