Tag: FDA

How Flexibility and Urgency from the DOH and FDA Can Save More Lives from COVID-19

Image Courtesy: Senate PRIB

Our lockdown is obviously working, no doubt. We can see it ourselves even from the windows of our own houses. But it is not enough by itself to flatten the COVID-19 curve. South Korea has reported to have flattened the curve through mass testing, not lockdown.

What we lack is the ability of the Department of Health to be more flexible. Hundreds of thousands of rapid test kits for donation by some local businessmen and procured from South Korea and China – already in use in those jurisdictions, having been certified by their regulatory agencies – have already arrived at least over a week ago. Yet, a big volume is still being held by Customs. Why?

Meanwhile, the Food and Drug Administration – an agency under the DOH – still refuses to issue even a provisional accreditation, which is needed so those test kits can be distributed for use particularly by those who have symptoms or those who have had direct contact with infected persons, even on a “do-it-yourself” basis, so they can immediately practice self-isolation should they test positive. In turn, this can prevent or at least minimize the spread of the virus.

That, instead of overly restrictive regulations imposed by our DOH, will certainly help obviate a possibly uncontrollable spread of the COVID-19.

As of last Monday, when we were deliberating on the just-signed Bayanihan To Heal As One Act, we tested only 1,500 Filipinos, more or less. With a population of 107 million, the worst is yet to come unless DOH and FDA act with urgency.

That is why I proposed an amendment – which is now Section 4 (j) of RA 11469, the Bayanihan to Heal As One Act. This aims to “ensure that donation, acceptance and distribution of health products intended to address the COVID-19 public health emergency are not unnecessarily delayed and that health products for donation duly certified by the regulatory agency or their accredited third party from countries with established regulation shall automatically be cleared: Provided, this shall not apply to health products which do not require a certification or clearance from (FDA).”

*****