Only 3 stem cell procedures allowed in PH - FDA

Posted at 05/04/14 12:23 PM

MANILA - Only three stem cell procedures are now allowed in the Philippines as the Food and Drug Administration (FDA) rejected the registration of other stem cell products.

FDA director general Kenneth Hartigan-Go said only the use of stem cells in “hematopoietic transplantation, corneal resurfacing with limbal stem cells, and skin regeneration with epidermal stem cells” are recognized by the FDA as “acceptable or standard healthcare procedures.”

Go said other stem cell therapies are considered illegal.

In an advisory, Go also said that not one stem cell or tissue-based product (HCT/Ps) had been registered by the FDA for compassionate or clinical trial use or for general use.

“Those who want to do stem cell outside of the three approved indications will have to register, either for compassionate use or clinical trial (as) these are the ones we inspect,” he added.

The FDA official cited lack of “evidence of technical competence, procedures and documentations” based on Current Good Manufacturing Practices and Current Good Laboratory Practices in denying the applications.

The applications also did not have ethical review procedures and systems accredited by the Philippine Health Research Ethics Board, the national accreditation body of the Department of Science and Technology, and had “unsubstantiated claims according to science, biology or pharmacology.”

In Aug. 13, 2013, the FDA issued Circular No. 2013-020 reiterating the need for hospitals and other health facilities offering stem cell therapies to register all human cells, tissues and cellular and tissue-based products pursuant to FDA Circular 2013-017 issued a month before.

The FDA gave the health facilities until Aug. 31, 2013 to apply for accreditation. Otherwise, the products shall be considered “unapproved and unauthorized for use.”

“All hospitals and health facilities are…warned that Republic Act No. 9711, otherwise known as the FDA Act, prohibits the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of any health product that is unregistered,” Go said.

He also maintained that the “use of HCT/Ps without the authorization or permission by the FDA is considered illegal in the country.”

“This warning extends to all unlicensed practitioners from other countries and to tourists who visit the Philippines for leisure and medical needs,” he added.