FDA sets deadline for stem cell registration

Manila, Philippines -- The Food and Drug Administration (FDA) ordered that all human cells, tissues, and cellular and tissue-based products, or HCT/P's, should be registered with the agency before August 31.

Acting FDA Director General Kenneth Hartigan Go said based on a circular issued last month that required all stem-cell products be registered in the country.

"Accredited and licensed facilities dealing with HCT/P's must file their applications for registration at the FDA before August 31, 2013. Otherwise, these products shall be considered unapproved and unauthorized for use," according to the FDA circular.

The FDA said it recognizes three applications of stem cell therapy. These are hematopoietic stem cell transplantation, corneal resurfacing with limbal stem cells, and skin regeneration with epidermal stem cells.

Go said all researches dealing with HCT/P's and the propagation of such other than their approved use are all considered clinical investigations and will have to comply with the existing FDA process and guidelines.

The FDA vowed to go after those perpetuators who endanger the public through the use of unauthorized stem cell products.

"Strict compliance is mandatory. FDA will pursue perpetrators who expose the Filipino public to the dangers of unapproved human cells and cellular-based products and will ensure that they are punished to the full extent of the law," according to the circular.

Report Stem Cell Failure

Meanwhile, the FDA asked patients who underwent stem cell treatment and suffered adverse reactions to submit a report online.

"Those who have availed themselves of such products or therapies and have experienced any untoward event or side effect or treatment failures as well as those currently availing such are highly encouraged to submit reports through the FDA website at www.fda.gov.ph under eReport and ADR (Adverse Drug Reaction) Report Section," FDA Advisory No. 2013-023 said.

The government agency assured all reports will be treated with confidentiality.

"This advisory is being issued as part of FDA's initiative to empower consumers in the surveilllance and monitoring of drug safety," the advisory added.

Early this week, the Department of Health (DOH) announced the deadline for the application for accreditation of hospitals and health facilities offering stem cell-based treatments in the Philippines.

The Bureau of Health Facilities (BHFS) will lead the assessment of the health facilities. Applications will be reviewed jointly by a bio-ethics committee and a hospital-based review board.

Some five big hospitals in Metro Manila have already submitted their application for accreditation.