FDA sets price cap for online selling of essential medical devices

Robie de Guzman   •   March 13, 2020   •   683

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.

No photo description available.

The agency said the price ceiling shall take effect immediately and shall remain valid “unless otherwise revoked, repealed or rescinded.”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 warns vs unsupervised use of Dexamethasone drug linked to COVID-19 treatment

Robie de Guzman   •   June 19, 2020

MANILA, Philippines – The Food and Drug Administration (FDA) on Friday warned the public against the use of steroid drug Dexamethasone without a prescription, following reports on its potential to treat novel coronavirus disease (COVID-19).

In an advisory, the FDA reminded the public that misuse or unsupervised chronic use of dexamethasone may lead to serious adverse reactions such as:

  • Immunosuppression or impairment of the body’s ability to fight infection
  • Gastrointestinal bleeding and ulcers
  • Electrolyte imbalance
  • Osteoporosis
  • Muscle weakness
  • Poor wound healing
  • Prolonged use of the drug may cause suppression of growth among infants and children
  • Obesity

If stopped abruptly, it may cause withdrawal symptoms such as hypotension, shock and coma.

“Dexamethasone is a steroid drug and is prescribed by a licensed physician based on the patient’s medical condition,” the FDA said.

“All are enjoined to report the dispense and/or use of the drug without a valid prescription to FDA Center for Drug Regulation and Research e-mail at cdrr.od@fda.gov.ph,” it added.

The agency also urged those using the drug to report any adverse reactions through this link.

The FDA warned that violators will be dealt with legal actions.

Duterte approves hiring of additional workers for FDA, DOST

Marje Pelayo   •   April 28, 2020

MANILA, Philippines — The Food and Drug Administration (FDA) is busy processing applications for licenses of coronavirus disease (COVID-19) test kits and all other products necessary in the country’s fight against the global pandemic.

The Department of Science and Technology (DOST), meanwhile, is focusing on research and development of treatment or vaccine against COVID-19.

Due to the volume of work and the high demand for additional workforce, President Rodrigo Duterte has allowed the two agencies to hire more personnel to join the government’s COVID-19 response.

“I have authorized these two offices — the FDA and the DOST — to employ as much as many that would be required to expedite [the processes] and to enable the agencies to work day and night. As I have said, we are fighting a war here, a crisis,” the President said in Filipino during his live address to the nation on Monday (April 27).

Meanwhile in his Joint Congressional Oversight Committee report, the President noted that the Department of Budget and Management (DBM) already approved the hiring of additional workers for the Department of Health (DOH). 

The DOH requested for additional 15,757 healthcare professionals who will be given three-months contract of service and will be funded with P2.7-billion.

The DOH said seven hospitals have signified their request for additional medical personnel to cope with the volume of workload in relation to the COVID-19 pandemic. MNP (with reports from Rosalie Coz)

FDA approves 16 COVID-19 rapid test kits

Aileen Cerrudo   •   April 20, 2020

The Food and Drug Administration (FDA) has approved 16 coronavirus disease (COVID-19) rapid antibody test kits for commercial use.

“These applications have completed necessary documentary requirements and have undergone review and evaluation by the FDA,” according to the FDA in a statement.

The rapid test kits detect the presence of antibodies in an individual’s blood or serum. This is to determine if the individual has previously contracted the coronavirus and developed antibodies for it.

FDA Director General Eric Domingo previously said they want people to have access to the testing kits but the testing should still be subjected to proper protocols.

“The rapid test kits will yield a faster result compared to PCR based kits, but it is important that a trained health professional will evaluate and interpret the results,” he said.

The FDA, moreover, reminds the public that each rapid test kits have different specifications and the tests should still be administered by trained health professionals.

“The agency reiterates that these kits are strictly for medical professional use only and not intended for personal use,” the statement reads.

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