FDA won’t regulate stem cell fees

Manila, Philippines -- The Food and Drug Administration (FDA) said the government will not regulate the prices and fees for stem cell therapies in the country as the discussion about the new and contentious form of treatment continues to heat up in the Philippine medical community.

''We don't regulate price and we will probably never do that,'' said Dr. Kenneth Hartigan-Go, FDA director, at a recent public hearing in Alabang, Muntinlupa, conducted by the FDA and Department of Health (DOH) on stem cell therapy regulation.

Earlier this month, 22 medical professional organizations in the country including the Philippine College of Physicians, Philippine College of Surgeons and Philippine College of Chest Physicians issued a declaration that denounced false claims, misinformation and exorbitant fees imposed for unproven stem cell treatments in the country.

At the public hearing, Go and Dr. Cynthia Rosuman of the DOH's Bureau of Health Facilities and Services (BHFS) discussed the DOH's Administrative Order 2013-0012, which set the rules and regulations governing accreditation of health facilities engaging in human stem cell, cell and cell-based therapies in the country.

The FDA's regulations on stem cell products and facilities were also discussed at the forum attended mostly by medical professionals.

Stem cell therapy, which Health Sec. Enrique Ona recently said ''has been considered as the future of medicine,'' has stirred debates among doctors and medical professionals in the country.

DOH order issued last March 18 said only stem cell preparations using adult human stem cells extracted from the same patient or from a human donor, human umbilical cord stem cells and human organ-specific cells are allowed in the country.

The order said these therapies can only be performed in DOH-accredited health facilities in the country.

Barred from being registered are stem cell preparations using imported and created human embryos for research purposes, human embryonic stem cells, aborted human fetal stem cells and plant parts labeled as stem cells.

The FDA issued circulars in July and August that ordered the registration of human stem cell-based products before Aug. 31. The FDA said it would only accept applications for stem cell therapy products intended for certain types of cancer, corneal regeneration and skin regeneration.

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FDA won’t regulate stem cell fees