Two congressmen may face charges of violating Republic Act No. 9711, or the Food and Drug Administration (FDA) Act of 2009, after they distributed to Quezon City residents an antiparasitic drug that they claimed would help treat COVID-19.
“[Ivermectin] is not registered particularly as drug for COVID-19 and, going by the FDA law, on its face, it would appear that the distribution of ivermectin as possible treatment for COVID-19 violates the FDA law,” Justice Secretary Menardo Guevarra said.
He made the remark in a television interview after Anakalusugan Rep. Michael Defensor and Sagip Rep. Rodante Marcoleta gave away free ivermectin tablets to at least 200 individuals in Quezon City on Thursday.
The two congressmen gave away the tablets at the Matandang Balara Barangay Hall Park inside Villa Beatriz Subdivision despite repeated warning from health officials that there is no scientific proof on the efficacy of ivermectin against COVID-19.
The Department of Health earlier said that people who are distributing ivermectin to treat COVID-19 are violating RA 9711 because it is not registered for the treatment of COVID-19.
The World Health Organization’s representative to the Philippines, Dr. Rabindra Abeyasinghe, also reiterated at a House hearing in March that there was no evidence the drug could treat COVID-19 and warned that advocates of the drug were only giving the public “false hopes.”
But Guevarra noted that FDA Director General Eric Domingo, who has also repeatedly warned against the improper use of ivermectin, has given the two exemptions on the use of the ivermectin on humans.
These exemptions include the issuance of compassionate special permit and if the drug was prescribed by a doctor and was compounded by a duly licensed pharmacist.
Doctors present
Sought for comment on what steps the FDA would take, Domingo said there are some licensed compounding pharmacies that can dispense ivermectin that is prescribed by doctors.
“There is no problem if doctors are seeing patients and prescribing meds that are properly dispensed,” he said in a text message.
However, Domingo did not say whether “proper dispensation” included prescribing drugs with no proven efficacy or were not registered with the FDA.
Witnesses said there were doctors present at the distribution of ivermectin on Thursday and appeared to have given prescriptions to residents who were required to sign a waiver.
“That person’s waiver does not extinguish any criminal liability, assuming such liability has been independently established,” said Guevarra.
‘In dire need’
The two lawmakers earlier said that “those who are in dire need” of ivermectin would be given a doctor’s prescription from the group Concerned Doctors and Citizens-PH.
But they did not clarify who would determine who was “in dire need” of a drug that has no proven value against a deadly disease.
It was not clear whether doctors could also be held liable for issuing prescriptions for unregistered drugs and against the advisories of the FDA, which is also a quasijudicial body.
“Personally, whether the two [exemptions] cited by the FDA director general has sound legal basis, that is something for further study. I’m not too sure on the soundness of the legal basis for the exemptions,” he added.
However, Guevarra, who is mandated by law to review the cases filed by state prosecutors, said he would leave it up to law enforcement and prosecutors to determine whether or not to take action and prosecute the two lawmakers. —WITH A REPORT FROM PATRICIA DENISE M. CHIU
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