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Thursday, March 28, 2024

Third hospital gets limited permit to use Ivermectin for Covid patients

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The Food and Drug Administration (FDA) on Thursday said another hospital has been received the go-signal to use anti-parasitic drug Ivermectin for its Covid-19 patients.

During a hearing of the House Committee of Good Government and Public Accountability FDA Director General Rolando Enrique Domingo said the unnamed health facilty is the third hospital to secure compassionate special permit (CSP) to treat Covid-19.

“Another hospital was granted [CSP] yesterday [Wednesday]. There is still one pending application,” said Domingo. FDA did not disclose the name of the said hospital, citing patient privacy, which comes with issued CSPs.

CSP is required before an unregistered drug, medical device or food product can be locally used.

Currently, FDA said, two parties are now applying for the certificate of product registration for their respective Ivermectin products.

According to the FDA, 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 agency reiterated that the Ivermectin has not been approved for treatment of any viral infection.

Clear guidelines

Amid debates on the use of Ivermectin for treating Covid-19, Speaker Lord Allan Velasco and Deputy Speaker Bernadette Herrera filed House Resolution 1711, calling for an inquiry into the policies and guidelines of the Department of Health and the FDA for the registration, utilization, manufacture, distribution or sale of drug products for Covid-19.

“While there is no actual cure for Covid-19, health, drug and medical experts have come up with a treatment protocol, including the administration of certain drugs and therapeutics currently allowed for use and treatment of Covid-19,” Velasco and Herrera said in the resolution.

They particularly cited DOH Department Memorandum 2020-0138, which adopts clinical practice guidelines on Covid-19, and FDA Circular 2020-12, which provides for the guidelines for the registration of drug products under emergency use for Covid-19.

They said the FDA Circular and other related guidelines have been questioned for being “arbitrary, bureaucratic, and inhumane for causing unnecessary delays in the approval and clearance of drugs and therapeutics for emergency use authorization or for use of drugs under compassionate special permit against the dreaded Covid-19 disease.”

Velasco, meanwhile, appealed to FDA to improve the efficiency and promptness of its procedures, specifically concerning the applications of local pharmaceutical companies for Certificate of Product Registration (CPR) and Emergency Use Authorization (EUA) permits.

“There are countless reports of local drug manufacturers whose products have been stuck in regulatory limbo for years. These bureaucratic impediments are something that we need to eliminate, especially during a public health crisis,” he said.

But Domingo told lawmakers that they need a law that will allow them to immediately approve the use of experimental drugs during a public health emergency.

Domingo said Republic Act 9711, or the Food and Drug Administration Act, only covers “regular everyday activities and not [public health] emergency.”

House Committee on Health chairman Angelina Tan had already filed House Bill 8666 authorizing the FDA to issue emergency use authorization during emergency situations.

Read full article on BusinessMirror

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