Duterte orders FDA to deal with illegal sale, distribution of ivermectin

Robie de Guzman   •   April 21, 2021   •   278

MANILA, Philippines – President Rodrigo Duterte has directed the Food and Drug Administration (FDA) to take the lead in dealing with illegal traders of anti-parasitic drug ivermectin amid push to use this to treat COVID-19, Malacañang said Wednesday.

“To ensure the safety and welfare of the public and at the same time avoid any unnecessary conflicts, the Food and Drug Administration (FDA) has been directed to take the lead in determining the course of action against the illegal trading/dispensing of Ivermectin,” Presidential Spokesperson Harry Roque said in a statement.

“The Philippine National Police (PNP) cannot arbitrarily determine on their own which drug/s should not be on the market. All operations to apprehend or seize goods must be done in coordination with the FDA,” he added.

Roque, however, clarified that the FDA is only ordered to stop the sale or trade of ivermectin for veterinary use that has been repackaged as human grade, including those that have no been determined by competent authorities as safe to be used in humans.

“Having said this, we advise the public to seek the advice of medical practitioners before taking medicines and/or supplements,” he said.

“The President is closely monitoring the developments concerning ivermectin here and abroad. He has even directed the Presidential Management Staff (PMS) to give him weekly updates on ivermectin studies and FDA-related clearance,” he added.

The FDA earlier granted two hospitals compassionate special permit for ivermectin.

The agency, however, reiterated that a compassionate special permit only allows experimental or unregistered drugs for limited off-label use but this is not an agency’s endorsement of its safety and efficacy.

The agency also emphasized that a compassionate use permit is different from certificate of product registration for the drug, which allows manufacturers to commercially sell the anti-parasitic drug for human use.

The FDA likewise stressed that only the hospital that has secured a permit for ivermectin’s compassionate use for humans will be allowed to import the drug through a licensed importer. Doctors who will use ivermectin to treat COVID-19 patients are required to report to the FDA on a monthly basis.

The FDA also said that distribution and promotion of ivermectin as a COVID-19 treatment remains prohibited in the country.

Ivermectin is registered in the country for veterinary use to prevent heartworm disease and treat internal and external parasites in certain species.

Ivermectin products registered for human use in the country were in topical formulations under prescription use only.

DOH studying possibility of mixing vaccine brands – FDA

Robie de Guzman   •   May 6, 2021

MANILA, Philippines – The Department of Health (DOH) is currently looking into the possibility of mixing different brands of vaccines against novel coronavirus disease (COVID-19), the Food and Drug Administration (FDA) said Thursday.

FDA director general Eric Domingo said the DOH is already drafting a set of guidelines that will allow a person to receive different brands of COVID-19 vaccines for first and second dose in case of severe allergic reaction and other adverse effects.

Aaralin po ngayon yan ng Department of Health, in fact, meron naman po talagang ongoing meetings ang Department of Health on that dahil meron po talagang instances na for example naturukan ka ng bakuna ng first dose tapos nagka-severe allergy ka so hindi ka na puwede sa second dose nun at kailangang isipin ngayon yung magiging alternative,” Domingo said during the Laging Handa briefing.

“Gumagawa na ng guidelines ngayon ang DOH kung paano ‘yung interchangeability or mixing ng vaccines in case the second dose cannot be given na identical doon sa first dose,” he added.

Domingo said this after President Rodrigo Duterte said he has requested China to recall the 1,000 doses of Sinopharm vaccines it donated following criticisms over his decision to receive a jab that has yet to secure an emergency use authorization from the FDA.

Duterte received his first dose of Sinopharm vaccine on Monday night.

Malacañang earlier said that the vaccine dose used on the president was covered by the compassionate special permit issued by the FDA for the Presidential Security Group.

Clinical trials on ivermectin to start in June – DOST

Marje Pelayo   •   May 6, 2021

MANILA, Philippines – Department of Science and Technology (DOST) Secretary Fortunato dela Peña said that preparations are underway for the anticipated clinical trials on the use of ivermectin as a treatment for COVID-19.

In his report to President Rodrigo Duterte on Wednesday (May 5), the official said the trials will be spearheaded by pulmonary doctor Dr. Aileen Wang of the University of the Philippines – Philippine General Hospital (UP-PGH) and will be implemented for eight months from June 2021 to January 2022.

He said the Department of Health (DOH) has allotted a total of P22 million for the trial of ivermectin.

It will be conducted on 1,200 volunteer adults, 18 years old and above, who are asymptomatic or non-severe COVID patients.

The team is awaiting ethics approval this month before proceeding with the trial.

“Ang ginagawa ay ethics approval para sa kanilang gagawin at recruitment ng staff na mag-a-administer ng clinical trials,” Dela Peña said.

They are currently coordinating with the Philippine Red Cross for the utilization of its facilities.

Other agents also under clinical trial are as follows:

* Randomized control clinical trial on the efficacy and safety of Tawa Tawa for adjunctive treatment of mild to moderate COVID-19 patients (11 months);

* Randomized, placebo-controlled trial on the safety and efficacy of Lagundi in patients with mild COVID and without comorbidities (10 months);

* Clinical trial on the safety and efficacy of virgin coconut oil (VCO) as adjunctive therapy for hospitalized COVID patients (12 months);

* Beneficial effects of VCO among suspect and probable cases of COVID-19 (14 months, extension included);

* Melatonin as adjuvant treatment for COVID-19 in patients requiring hospitalization (9 months) ;

* Convalescent Plasma as adjunctive therapy for hospitalized COVID-19 patients. (12 months).

Dela Peña noted that the duration of clinical trials for ivermectin is almost similar in period as other agents. The progress of each study still depends on the number of patients who want to volunteer for the trial.

“Kapag dumadami ang pasyenteng magbo-volunteer, mas mapapabilis ang pagtatapos ng mga trials,” the official assured.

BOC-NAIA intercepts 20,000 tablets of ivermectin, other regulated drugs

Maris Federez   •   May 6, 2021

MANILA, Philippines — The Bureau of Customs Port of NAIA (BOC-NAIA) has intercepted undeclared ivermectin and other regulated drugs declared as food supplements and multi-vitamins and multi-mineral capsules.

In a press release dated May 6, the BOC said the shipment was imported by Finstad Inc. from New Delhi, India.

The said drugs including the undeclared 20,000 capsules of ivermectin were reportedly concealed in the inner portion of the subject shipment along with other declared regulated items, it added.

The BOC said that it coordinated with the Food and Drug Administration (FDA) regarding the shipment.

In her reply to a BOC query, FDA Director Jesusa Joyce N. Cirunay of the Center for Drug Regulation and Research said, “At present, the drug is under compassionate use in Specialized Institutions authorized by FDA through the issuance of Compassionate Special permit (CSP).”

Furthermore, Director Cirunay added, “In case ivermectin has been granted authorization, a valid License to Operate (LTO) as Drug Importer and Emergency Use Authorization (EUA) or Certificate of Product Registration (CPR) shall be presented.”

The BOC-NAIA team said that in conformance with the directive of Customs Commissioner Rey Leonardo B. Guerrero, it remains committed to expediting the processing and release of Covid-19 vaccines, drugs, and other medical supplies.

Moreover, it assured that it will also be vigilant and will further strengthen border security and protection efforts to curb all smuggling attempts to import unregistered, undeclared goods and/or misdeclared goods without the necessary clearance and permits from FDA.

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