FDA: Stem cell therapy regulated, not banned in Phl

This has reference to the column In search for truth by the Hon. Senator Ernesto Maceda, which was published last July 13, 2013, with the title “Approved stem cell.” Hon. E. Maceda wrote in the first paragraph, “The Food and Drug Administration (FDA) under Circular 2013-017 has banned stem cell therapy in the country. Why? What is their basis?”

We would like to clarify that the FDA has not banned stem cell therapy in the Philippines.

Please be informed that the FDA Circular was issued to strengthen the DOH-FDA regulatory framework to ensure patients’ safe access to FDA-approved stem cells from licensed and competent medical practitioners in DOH-licensed health facilities in the Philippines.

The FDA issued Circular 2013-017, dated July 8, 2013, is based on the provisions of DOH Administrative Order (AO) 2013-0012, dated March 18, 2013, known as “Rules and Regulations Governing the Accreditation of Health Facilities Engaging in Human Stem Cell and Stem-Cell Based or Cellular Therapies in the Philippines.” Consistent with DOH AO 2013-0012, FDA Circular 2013-017 required registration and FDA approval before the following stem cells are injected in patients: a) genetically altered human adult and umbilical cord stem cell; b) adipose or fat cells derived human stem cell; c) human cells, tissues, and cellular and tissue-based products that are subjected to genetic administration. The FDA-DOH bans the following activities or parenteral forms of stem cells: a) creation, importation, promotion, marketing and use of human embryos, human embryotic stem cells: a) their derivatives; b) aborted human fetal stem cells and their derivatives for human treatment and research; c) and plant parts labeled as “stem cells.”

Requiring mandatory registration of stem cell-based products in the Philippines will greatly reduce the risks of patients from contracting infectious diseases or experiencing severe adverse reactions or events, which may lead to permanent disabilities, physical deformities, autoimmune diseases or worst death.

We would like to refer you to FDA Advisory No. 2013-012, dated May 15, 2013, Subject: Public Health Warning Against Receiving Unapproved Stem Cell Preparations in Non-health Facilities. In this Advisory, the FDA advised all patients to consult only with duly-licensed doctors who practice stem cell therapy in DOH-approved health facilities. Moreover, patients were encouraged to verify with the FDA before undergoing the procedures using our FDA website (http://www.fda.gov.ph) inquiry and complaint desk platform, info@fda.go.ph. With the current requirement to register all human stem cell-based products, the FDA will be able to post all approved stem cells and service providers in the country. And in case of adverse event or complaints, the patients were advised to use FDA website facility report@fda.gov.ph.

We hope this has clarified the statement made  by Hon. Ernesto Maceda. — KENNETH Y. HARTIGAN-GO, MD, Acting Director General, Food and Drug Administration