Things to know about unregistered anti-COVID-19 drug products

Loreben Tuquero
Things to know about unregistered anti-COVID-19 drug products
The FDA warns against unregistered drug products, including the Fabunan antiviral injection, that are being promoted as treatments for COVID-19

MANILA, Philippines – As the pandemic trudges on, talk of coronavirus cures being developed in the Philippines has been circulating on social media.

These reports were reinforced after President Rodrigo Duterte offered a P50-million reward to any Filipino scientist who can develop a vaccine against COVID-19.

One drug being touted as a potential cure for COVID-19 is the Fabunan antiviral injection (FAI), which is unregistered with the country’s Food and Drug Administration (FDA).

In a Facebook post, the Fabunan Medical Clinic said that the FAI is not “commercially sold.” However, it is still being promoted by self-proclaimed “advocates” in relation to COVID-19. On social media platforms, a false claim that the drug was already approved by the government even became viral.

While advocates claim that the drug may be a cheap home treatment and that it could cure COVID-19 in 3 days, the antiviral injection cannot be sold or distributed without being registered.

Rappler reached out to the FDA through officer-in-charge Eric Domingo regarding this issue and was told by the FDA Center for Drug Regulation and Research (CDRR), “They are not allowed to sell, offer for sale nor distribute the Fabunan antiviral injection since it has no CPR [certificate of product registration].” 

Apart from the antiviral injection, the FDA has warned the public against other unregistered drug products that claim to treat or prevent COVID-19. This includes Prodex-B, a drug combination of Procaine and Dexamethasone with Vitamin B.

“Unregistered drug products have no guaranteed quality, safety and efficacy data which may lead to patient harm,” the FDA said in its advisory against Prodex-B.

What is the process for registering this kind of drug? And what is the status of coronavirus-related drugs that are going through this process?

Licensing

Before conducting any drug-related operations, drug establishments must first secure a license to operate. Such a license allows drug establishments to engage in the manufacture, importation, distribution, sale, and sponsorship of drugs, among others. 

There are different license classifications that a drug establishment may apply for, namely:

  • drug manufacturer (as well as repacker, packer, or trader)
  • drug distributor (exporter, importer, or wholesaler)
  • drugstore/pharmacy/botica/similar outlets
  • retail outlet for non-prescription drugs
  • sponsor
  • contract research organization

When applying for a license to operate, an establishment must submit various documentary requirements depending on the classification.

For drug distributors, requirements include an application form, proof of business name registration, credentials of the pharmacist, risk management plan, location plan, proof of payment, and self-assessment tool kit.

Applications will then be reviewed by respective FDA regional field offices, and a pre-opening inspection will follow. If the license is approved, drug distributors would also be subjected to routine post-licensing inspection.

In the case of the Fabunans, the Agnes Fabunan Medical and OB-Gyne Clinic secured a license to operate as an importer. According to the CDRR, this means they are allowed to import finished drug products for wholesale distribution to FDA-licensed drug distributors or outlets.

Registration

Drug products cannot be distributed or sold without a certificate of product registration issued by the FDA. Even if a drug establishment has a license, it would still need to secure a CPR for each drug product it wants to sell or distribute.

Only after securing a license can a drug establishment apply for a CPR, which would allow it to engage in activities such as the importation, distribution, or sale of a drug product. 

Drug registration has different requirements for each product classification, which depends on the contents of the drug product. Product classifications include new drugs under monitored release, biological products, and generic prescription medicines, among others.

CPR application for new drugs under monitored release, for example, requires several documents, such as product information and the body of data pertaining to the drug’s quality. It also requires non-clinical documents which include pharmacology, pharmacokinetics, and toxicology summaries and reports.

Clinical documents are also required, covering summaries of clinical pharmacology, efficacy, and safety, among other studies.

“With regards to the Fabunan antiviral injection, we do not have the complete information about this product. There are no details as to whether it is imported as finished drug product or locally manufactured,” the CDRR said.

The CDRR added that if the FAI is locally manufactured, the clinic would then need a license as a drug manufacturer before applying for a certificate of product registration.

Registering drug products for COVID-19

Under normal circumstances, it would take 254 calendar days to issue a certificate of registration for drug products.

But in light of the pandemic, the FDA released Circular No. 2020-012, which provides streamlined requirements and an application process for registering drug products under emergency use for COVID-19.

Thus, the CDRR said applications of drug products related to COVID-19 are expedited. “This is to ensure that there is enough supply of registered drugs for its indicated disease and also as possible treatment for COVID 19,” the CDRR said. (READ: How can the Philippines secure enough drugs or vaccines against coronavirus?)

The circular covers drug products that are considered for use in hospitalized, probable, or considered patients with COVID-19, as listed by the Philippine Society for Microbiology and Infectious Diseases and as adopted by the Department of Health. These include Tocilizumab, Lopinavir + Ritonavir, Chloroquine Phosphate, and Hydroxychloroquine Sulfate.

What’s being done now?

Investigational drug products are still going through clinical trials. The FDA regulates clinical trials conducted by drug developers, clinics, hospitals, universities, and research institutions, among others.

However, it may take some time before we see a registered drug product for COVID-19 in the country. As of Thursday, May 14, the CDRR said there has been no application filed to register a drug product with an indication for COVID-19 treatment.

“No drug has been approved with a specific indication for the treatment of COVID-19 in the Philippines,” the CDRR said.

In the meantime, the Philippines is participating in the World Health Organization Solidarity Trial, a large-scale study that investigates antivirals (Remdesivir and Lopinavir + Ritonavir), antimalarial (Chloroquine and Hydroxychloroquine), and the cytokine Interferon Beta 1-a.

However, experts have said that at the earliest, we could have a cure for the novel coronavirus is late 2020 and a vaccine in late 2021. (READ: What you need to know: Coronavirus cures, vaccines being tested)

For now, consumers must remain vigilant against unregistered products that claim to treat or prevent COVID-19. These may be reported to ereport@fda.gov.ph. – Rappler.com

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author

Loreben Tuquero

Loreben Tuquero is a researcher-writer for Rappler. Before transferring to Rappler's Research team, she covered transportation, Quezon City, and the Department of the Interior and Local Government as a reporter. She graduated with a communication degree from the Ateneo de Manila University.