FDA sets price cap for online selling of essential medical devices

Robie de Guzman   •   March 13, 2020   •   289

MANILA, Philippines – The Food and Drug Administration (FDA) on Thursday said it has set a price cap for the selling of essential emergency medicines and devices online amid the growing demand spurred by the increasing novel coronavirus infections in the country.

In an advisory, the FDA said the online selling of any of the specified emergency medical supplies that are beyond the price ceiling set in the Department Memorandum No. 2020-0058 issued by the Department of Health (DOH) are prohibited.

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The agency said the price ceiling shall take effect immediately and shall remain valid “unless otherwise revoked, repealed or rescinded.”

It also directed all its Inspectors and Regulatory Enforcement Unit agents to conduct “exhaustive monitoring” of all online platforms to ensure full compliance of the circular and the price declaration issued by the DOH.

FDA approves use of 5 rapid COVID-19 test kits

Robie de Guzman   •   March 30, 2020

MANILA, Philippines – The Food and Drug Administration (FDA) on Monday (March 30) said it has approved the use of five rapid test kits for novel coronavirus disease (COVID-19) in support of efforts to address the pandemic.

In a statement, the FDA said these point-of-care test kits are registered for use in countries with reliable regulatory agencies such as China and Singapore.

“We approve kits that are registered and used in countries with advanced technology and wide experience with COVID 19,” FDA Director General Eric Domingo said.

Domingo said the rapid test kits will yield a faster result compared with PCR-based kits, but he stressed that its results should be evaluated and interpreted by a trained health professional.

“We have to be very cautious in using these rapid test kits because they measure antibodies and not the viral load itself,” he said.

As a safety precaution, the FDA requires all rapid test kits to have the following product inserts or label: “This product is strictly for medical professional use only and not intended for personal use. The administration of the test and interpretation of results should be done by a trained health professional. Confirmatory testing is required.”

“The body takes time to develop antibodies and this might give a negative result for patients who have been infected but antibodies have not yet developed antibodies,” Domingo said.

“A positive result due to cross reaction with other bacteria or viruses is also possible, which is why a confirmatory PCR based test is still required,” he added.

The FDA also announced it has approved the SARS Cov2 kit by Gene Xpert from Abbott Laboratories.

This PCR-based test kit, the latest in the 17 kits approved for commercial use, can detect the virus within five minutes, according to the agency.

FDA warns public vs use of ‘Prodex-B’ as anti-viral treatment for COVID-19

Robie de Guzman   •   March 30, 2020

MANILA, Philippines – The Food and Drug Administration (FDA) on Monday (March 30) warned the public against the use of a drug cocktail called ‘Prodex-B’ as an anti-viral treatment for novel coronavirus disease (COVID-19).

In an advisory, the FDA said the drug combination of Procaine and Dexamethasone with Vitamin B or Prodex-B is not registered in the agency.

The FDA issued the warning following “baseless claims” circulating on social media that this drug cocktail has promising effects against viral infections and diseases.

“Procaine is an anesthetic used to reduce pain on injections, while Dexamethasone is a corticosteroid which must be used cautiously due to its side effects including immunosuppression or weaker immune system leading to vulnerability to infections,” the advisory reads.

The FDA said that unregistered drug products have no guaranteed quality, safety and efficacy data which may lead to patient harm.

The agency advised those who may have received Prodex-B to monitor their health condition for any adverse reactions, and such should be given immediate medical attention.

They may report their cases to the FDA by messaging emails at cdrr@fda.gov.ph and ereport@fda.gov.ph.

The FDA also called on health facilities and practitioners to follow the recommended treatment guidelines for COVID-19 patients issued by the Department of Health.

FDA eases rules to expedite Customs release of imported respirators, other medical devices

Robie de Guzman   •   March 26, 2020

MANILA, Philippines – The Food and Drug Administration (FDA) has relaxed its rules to expedite the release of imported respirators, ventilators and other medical devices which are essential in responding to the novel coronavirus disease (COVID-19) pandemic.

In a letter dated March 23 addressed to Bureau of Customs (BOC) Rey Leonardo Guerrero, FDA Director General Rolando Enrique Domingo advised the bureau that importers of ventilators, respirators, and their respective accessories for commercial purposes need only to present copies of their license to operate.

“On the other hand, foreign donations of ventilators, respirators, and their respective accessories to be used in the treatment of COVID-19 patients need not require FDA clearance prior to customs release,” Domingo said.

“We hope that the measures being introduced would expedite the customs release of ventilators, respirators and their respective accessories which are vital in responding to the threat of COVID-19,” he added.

Foreign Affairs Secretary Teodoro Locsin, Jr. lauded the FDA’s move.

“No more FDA approval needed. No more excuses to delay release from Customs. Thank you all,” he said in a Twitter message which is accompanied by the FDA letter.

A similar rule for commercial imports and foreign donations of personal protective equipment such as face masks and head covers was also issued by the FDA earlier.

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