FDA explains special permit not for selling ivermectin

The Food and Drug Administration (FDA) on Friday clarified that a compassionate special permit (CSP) for any medicine is neither a registration of nor a permit to market a drug.

FDA Director General Dr. Eric Domingo told a media briefing that while one hospital has been granted a CSP for using human-grade ivermectin to treat COVID-19 patients, the doctors are solely responsible for possible side effects.

But Iloilo Rep. Janette Garin said Health Secretary Francisco Duque III should review Domingo’s grant of the CSP for the controversial drug, and stop its use if merited.

“The situation calls for the leadership of the Department of Health (DOH) to speak up and put order in his house … ” Garin, herself a former health secretary, said in a text message. “Very easy for Secretary Duque to police his people … Now, more than ever, we need his voice. It’s a mandate he has been entrusted with.”

Domingo emphasized the role of doctors treating a patient with a drug on a CSP, which also specifies dosage and time period.

“It is up to them to discuss with patients the possible side effects [of the drug]. It can’t be sold, and it’s limited. [The CSP] is very defined—from how many patients and how many tablets, and until when,” he said.

According to Domingo, a CSP is usually only good for a year. “But any doctor or hospital can apply for a CSP, provided the drug they wish to use falls [within] eligibility standards,” he said.

Domingo said one doctor or one hospital can apply for a CSP when the medicine they want to use is not available or approved here, but registered overseas.

“This is for limited, life-threatening diseases such as cancer or HIV-AIDS. They can also apply if the medicine is already undergoing clinical trials,” he said.

And since there are current clinical trials for the use of ivermectin as a therapeutic drug for COVID-19, an application for a CSP is allowed, he added.

Domingo also said that so far, only one hospital has applied for and been granted a CSP for ivermectin. As he did on Thursday, he declined to name the hospital, citing patient privacy.

Compliance

Garin questioned whether the CSP was compliant with DOH requirements, as stated in two administrative orders issued in 1992 and 2020.

According to the DOH, a CSP may be issued to a specialized institution or specialty society or for an “investigative product,” provided that there is ongoing phase 3 clinical trials in the country of origin or in other countries.

“The administrative order on CSP was issued by [Duque],” Garin said. “Violations there are very clear. Minimum requirements are not complied with. A veterinary medicine used wrongly can cause many adverse effects.”

Ivermectin is currently commercially available in the country only as an antiparasitic drug for animals. Medical advocates are pushing human-grade (or USP-grade) ivermectin as a safe and inexpensive drug for COVID-19 patients.

Garin said she was not considering filing a petition for a temporary restraining order (TRO) against the CSP for ivermectin.

“That should not be given as a task to other doctors whose hands are all full helping in the pandemic response. How long will that TRO take? Why bring to courts a scientific discussion? And while awaiting, we have a lot of Filipinos out there being deceived and given false hopes,” she said.

Several members of the House of Representatives have been pushing for the use of USP-grade (United States Pharmacopeia) ivermectin as an inexpensive medicine to treat COVID-19 patients.

Phase 3 trials

Garin said she was unsure whether there were ongoing phase 3 trials for ivermectin, but she cited statements from other regulatory agencies that “no benefits have been seen in the smaller trials,” and that this would mean that “they will not proceed to bigger trials.”

A check of ClinicalTrials.gov, a website maintained by the United States’ National Institute of Health, showed that out of 626 phase 3 clinical trials for possible COVID-19 treatments all over the world, 14 involve the use of ivermectin in prevention and treatment.

‘Out of place’

Of the 14 phase 3 clinical trials, two trials were completed in August and November 2020, and one was completed in January 2021. The other trials are still in the process of recruiting participants.

“If it’s human-preparation [ivermectin], then at least copies of the results of phase 1 and 2 and ongoing phase 3 should be presented. I think no trial application has been submitted to the FDA,” Garin said.

Granting a CSP would be “out of place unless a trial will really be conducted,” she said.

Garin also questioned Domingo’s decision not to reveal the name of the hospital that received the CSP, saying “that’s a no-no in research.”

“The situation can be rectified if they have the documents from the country of origin. Not sure in this case where the ivermectin will be coming from. Secretary Duque should be on top. His presence is very important in situations like this,” the senior deputy minority leader said.