Senators and the country’s three pandemic czars have agreed on a plan for immediate legislative action against red tape in the Food and Drug Administration (FDA), which hampers government efforts against COVID-19.
Sen. Panfilo Lacson specifically mentioned permits issued by the FDA, as he noted at least 20 requirements are needed to apply for Emergency Use Authority (EUA).
“It takes forever for them to act, in obvious violation of the Anti-Red Tape Authority (ARTA), while in India, according to Ambassador Ramon Bagatsing, it only takes three days to approve,” Lacson further emphasized.
“We agreed with a plan to resolve quickly enough,” said Lacson who with Senate President Vicente Sotto III attended a meeting with vaccine czar Sec. Carlito Galvez, testing czar Sec. Vince Dizon and contact tracing czar, Baguio City Mayor Benjamin Magalong.
Meanwhile, the Philippine Red Cross (PRC) is open to conducting clinical trials in its isolation facilities, provided that the government will facilitate the procedures, Senator Richard Gordon said on Friday.
“We are open to this as long as the patient will give their consent and as long as the government will conduct it,” Gordon said during the Laging Handa briefing.
Gordon reacted to Department of Science and Technology-Philippine Council for Health Research and Development (DOST-PCHRD) executive director Dr. Jaime C. Montoya’s statement that the government is eyeing the use of PRC facilities as sites for the clinical trial and their patients can participate voluntarily in the study.
The DOST scientists and the FDA officials should supervise the clinical trials in their facilities, the senators said.
In the same meeting, the Senate and FDA also agreed that P90 billion will be needed for next year’s vaccine procurement budget, to be included in the regular budget of the Department of Health (DOH).
Lacson said the amount will be itemized for vaccines instead of putting it under the Unprogrammed Fund to ensure its availability.
He also said the P20 billion for this year under Bayanihan 3 should be realigned from the unused appropriations of several executive agencies as it is allowed under the Constitution as well as the extended effectivity of the Bayanihan law already passed.
According to Lacson, they also tackled the business sector’s commitment to make available spaces in malls and hotel ballrooms for some 5,000 vaccination centers.
The 1,200 of the vaccination centers, Lacson said, are in the National Capital Region and can help inoculate some 58 million Filipinos by year end, assuming that enough doses will arrive as scheduled.
The senator said government has related they are pursuing the COVID-19 vaccines round the clock.
Meantime, he said continuous simulations are being done to ensure efficiency at the proper time.
Gordon said he is not against the trial of ivermectin.
Like in the studies on convalescent plasma as a possible treatment for COVID-19, he said ivermectin clinical trials are needed to settle the issue at once.
“Let us give it a chance so that we will determine its efficacy once and for all,” he said.
“I would say ‘no’ if there is no proper supervision and proper approval from the government because it is hard to risk the lives of the people in these testing,” he said.
President Rodrigo Duterte has ordered the local clinical trial for the anti-parasitic drug ivermectin amid calls to authorize it for the use of COVID-19 patients.
Only animal-grade ivermectin was approved for commercial distribution in the Philippines.
The clinical trials in the country may start at the end of May or in early June.
Prior to this, the DOST had said there was no need to conduct a local trial for the antiparasitic drug since there were already several studies ongoing across the globe.
Aside from local health agencies and experts, the World Health Organization, US FDA, European Medicines Agency, and even ivermectin manufacturer Merck do not recommend ivermectin as a COVID-19 treatment based on current evidence.