THE Anti-Red Tape Authority (ARTA) is lobbying to include Ivermectin, an anti-parasitic drug being studied as a potential cure for Covid-19, in the Department of Health’s (DOH) treatment protocol to qualify for emergency use.
This, as the Food and Drug Administration (FDA) on Tuesday warned anew the public against the purchase and use the drug against Covid-19 while its safety as such has not been conclusively proven.
ARTA Director General Jeremiah Belgica said in an online briefing on Tuesday that Ivermectin being tagged as drug for emergency use will speed up its mass production if needed. Currently, compounding the drug is only allowed if there is a specific prescription of doctors for their patients.
Before, the ARTA official said there were pharmacies compounding Ivermectin, but they halted production due to “confusion” regarding the number of drugs being released, which is yet to be clarified.
Belgica said he is set to meet with DOH on Wednesday to talk about the matter and to request Ivermectin’s inclusion in the Covid-19 treatment protocol.
“ARTA also will be making our recommendations and send it to agencies concerned, the DOH, the FDA [Food and Drug Administration], and of course, the Office of the President,” he added.
Belgica said that two pharmaceutical firms—Lloyd Laboratories Inc. and Pascual Laboratories Inc.—are already interested in registering with DOH so they can compound Ivermectin. There is no information yet if they will go into mass production of the said drug.
Based on previous pricing, a capsule of Ivermectin costs P30 or P40, but Belgica said prices may go down with mass production.
On Monday, ARTA called on the FDA to expedite the processing of Compassionate Special Permit (CSP) application process of Ivermectin. CSP allows for the registration of food and drugs for applicants, providing License to Operate, a Certificate of Product Registration, a Letter of Intent with undertaking to take full responsibility and other requirements.
“With this directive, FDA needs to be clear with their timelines and come up with a fixed list of requirements in accordance with their submitted Citizen’s Charter,” Belgica said.
Based on FDA’s updated Citizen’s Charter, ARTA noted that it shall only the three working days to act on CSP requests.
The Republic Act 11032 or the Ease of Doing Business law mandates that all government processes must only run for 20 days at maximum, depending on the transaction. Otherwise, the anti-red tape regulator may declare automatic approval of the pending applications before the agency given that the submitted requirements are complete and fully paid for.
FDA at House hearing
During the hearing of the House Committee on Health on Tuesday, FDA Director General Eric Domingo said any use of Ivermectin for the prevention or treatment of Covid-19 should be avoided as the benefits and safety for this purpose has not been established.
“Data from clinical trials are necessary to determine whether Ivermectin is safe and effective in treating or preventing Covid-19,” Domingo said.
“Ivermectin is not approved by the FDA for treatment of any viral infection . . . using these products in humans can cause serious harm. Animal drugs are often highly concentrated and can be highly toxic to humans,” he added.
Currently, Domingo said the registered Ivermectin products in the country for human use are in topical formulations under prescription use only, saying this is used for the treatment of external parasites such as head lice and skin conditions such as rosacea.
The FDA said the registered oral and intravenous preparations of Ivermectin are veterinary products which are approved for use in animals for the prevention of heartworm disease and treatment of internal and external parasites in certain animal species. The drug is an important part of a parasite control program for some animal species and should only be administered according to its approved indication, or as prescribed by a duly licensed veterinarian.
However, Domingo said there are legal ways to use Ivermectin in the country by going through the process.
“All applications for authorization related to the Covid-19 mitigation are evaluated by FDA with utmost diligence an priority,” he said.
Last March 25, 1-PACMAN Party-list Rep. Enrico Pineda filed House Resolution No. 1684 seeking an explanation from the FDA regarding its decision on Ivermectin and for Congress to enact regulations that will ensure the FDA and the Department of Health (DOH) will consider all possible cures for Covid-19.
Citing clinical trials conducted in many countries, Pineda said Ivermectin was found to reduce the effects of Covid-19 on infected patients when used with vitamins and supplements.
He said Ivermectin is also considered cost-effective compared to other repurposed Covid-19 drugs, such as Remdesivir, which costs P28,000 per vial and must be administered twice daily until such time that the patient is discharged.
“Ivermectin costs only around P35, to be administered once daily for three days—totaling to just a little over P100,” Pineda said.
Also, House Deputy Speaker Bernadette Herrera has urged regulators to “keep an open mind” on Ivermectin.
“In the absence of an efficient treatment that can be used for the management of Covid-19, our regulators must maintain a more open mind and take a closer look at Ivermectin as a possible cure for the disease, which has so far killed more than 13,000 people across the country,” Herrera said.
Herrera noted that the drug has been proven to reduce the effects of Covid-19 in infected patients when used with vitamins and supplements, based on several successful clinical trials around the world.
Ivermectin is widely used as a Covid-19 drug in India, South Africa and many Latin American countries, Herrera pointed out.
Anakalusugan Rep. Michael Defensor also filed a resolution calling for an investigation on the possible use of Ivermectin against Covid-19.
In the same hearing, Dr. Allan Landrito of Concerned Doctors and Citizens of the Philippines (CDC Ph) said the Philippines should look at what other countries have achieved for using the Ivermectin.
Landrito said Ivermectin allows natural infection to occur but prevents the disease from developing.
“Ivermectin is a natural product discovered in 1975. It has properties against Dengue, chikungunya even SARS Covid,” he said.
He also added the safety and efficacy of Ivermectin for human use was established and described as having zero impact on human biochemistry.