FDA mulling revocation of Belo Alabang’s license to operate

Belo Medical Group's (BMG) clinic pharmacy in Alabang may lose its license to operate following its alleged "gross defiance to obey the legal orders" issued by the Food and Drug Administration (FDA) for an inspection earlier this month.

“The Belo Medical Group’s pharmacy is under FDA’s jurisdiction and we have legal authority to enter and inspect it, in reasonable hours and manner, by our inspectors,” the FDA said in a statement on Thursday.

FDA laid down administrative and criminal charges against BMG after staff of the Alabang clinic and its pharmacy allegedly barred officials from inspecting the premises on February 9.

A Summons with Preventive Measure Order (SPMO) was previously issued to BMG for the inventory and seizure of 11 skin care products that did not pass through FDA's registration and certification process.

The FDA issued another SPMO after the February 9 incident, ordering the padlocking of the Alabang pharmacy and clinic on February 19.

During the February 19 operation, the FDA observed that the pharmacy operated "without the direct supervision of the registered pharmacist and did not have the PRC License and Board Certification of the pharmacist displayed in a conspicuous place as required by law."

"In view of these violations, the FDA's Regulatory Enforcement Unit has recommended to FDA Director General Nela Charade Puno the cancellation of BMG's LTO," the FDA said.

The products in question are the following:

• ZO Medical by Zein Obagi
• MD Glycogent Exfoliation Accelerator 10% concentration
• ZO Medical by Zein Obagi Foamacleanse Gentle Foaming Cleanser for all types
• ZO Medical by Zein Obagi Oclipse Sunscreen/Primer SPF 30 Protection
• Belo Illuminating Cream Alpha Arbutin+Liquorice
• Belo Prescriptives Keralyt 2 Cream
• ZO Medical by Zein Obagi MD Melamix Skin Lightener & Blending Creme Hydroquinone USP 4%
• ZO Medical by Zein Obagi MD Melanin Skin Bleaching & Correcting Creme Hydroquinone USP 4%
• Belo Prescriptives Acne Astringent
• Belo Prescriptives Belo White
• Belo Prescriptives DLC Peeling Creme
• ZO Medical by Zein Obagi MD Cebatrol

“The Belo Medical Group, or any drug or cosmetic company for that matter, may claim that their products are registered in other countries, safe and their efficacy are proven. But they cannot sell them to the public unless they have undergone product evaluation and certification from the Philippine FDA, to ensure their safety and efficacy,” the FDA said.

Belo: No padlock

Belo issued a statement on February 19 denying that its Alabang clinic was closed, stating that the company fully cooperated when the FDA served the summons with an order to close the clinic's pharmacy.

"The FDA upon inspection found no presence of the products in question and therefore did not padlock the clinic as opposed to what was recently inaccurately reported," they wrote.

Corporate Communications head John Eric Ho, in the same statement, said the company is concerned with the FDA's choice to conduct its inspections with media present.

"We reiterate that we understand and support the FDA's mandate and we have undertaken all necessary steps to comply. However, we would like to express our concern as to how these inspections have been conducted with the presence of the press. We feel that this is unnecessary and highly irregular," he wrote.

The group stressed that a response was submitted to the FDA on February 19, which is within the prescribed period indicated in the summons presented to the company last February 9. — BM, GMA News