FDA laments lack of off-label practice laws

The Food and Drug Administration (FDA) on Friday said that the off-label use of medicines, or the use of a medicine that is not officially approved or for a different purpose than the one the medicine was intended for, could not be punished because no law penalized it.

“Wala po tayong batas na nagpapataw sa mga doktor to do off-label practice. It's a personal suit also with the patient,” FDA chief Samuel Zacate said in a Bagong Pilipinas Ngayon interview.

(We do not have a law that penalizes doctors engaged in off-label practice. It's a personal suit also with the patient.)

“For example, ako po iyong doktor, nireseta ko po iyong gamot for diabetes tapos ginamit po ng pasyente na pampaputi. Hindi po puwede nating parusahan ang doktor kasi wala tayong batas to do it,” he added.

(For example, I am your doctor. I prescribed a diabetes medicine, and then the patient used it for skin-whitening. We can't punish the doctor because we don't have a law for it.)

According to Zacate, off-label practice could be considered medical malpractice.

In January, the Department of Health (DOH) warned against using intravenous (IV) glutathione. Such use was hazardous and not approved by the FDA.

Health Secretary Ted Herbosa said, “IV glutathione will whiten your skin and make you look really like Caucasian, but it can damage your kidneys and kill you.”

Herbosa pointed out that IV glutathione was not safe to use in clinics and was designed for hospitals because it was used as a rescue medicine for chemotherapeutic complications of cancer.

“I’m telling you from the Department of Health. It is not safe. The FDA has not registered it for skin whitening. If there’s someone using it, it is illegal,” said the Health Secretary.

Herbosa cited a report of a woman who died after allegedly receiving glutathione and stem cell intravenous infusion from a Quezon City clinic. — DVM, GMA Integrated News