Tag: FDA

On the DOH’s ‘Adjustments’ in Dealing with the COVID-19 Threat

At last, the Department of Health leadership is making some adjustments to address the COVID-19 threat, but only now after so much time has been wasted.

For one, through the private sector’s initiative in coordination with the Inter-Agency Task Force on Emerging Infectious Diseases and other government agencies, massive rapid testing will start tomorrow, April 14, if it is not being done already.

Secondly, contact tracing, hopefully, will now be more efficient with the latest guideline issued by IATF for mandatory disclosure of COVID-19 infected persons for more efficient self-quarantine.

Thirdly, after a long and unnecessary delay, the FDA approved the use of test kits – including at least 10 rapid antibody test kits and 23 PCR-based test kits as of April 8. The delay was amid the willingness of private donors to spend big money to help accelerate mass testing through the use of rapid antibody test kits, and even after we asked the FDA about the usefulness of such rapid test kits as early as our March 24 caucus prior to our 18-hour plenary debates to pass Republic Act 11469 (Bayanihan to Heal As One Act) on the same day, with some Cabinet members in attendance.

What I can’t understand for the life of me is why the DOH keeps issuing circulars that seem to circumvent Sec 4(j) of the Bayanihan Act that provides for some leeway for donated test kits that otherwise have already been in use in other jurisdictions, by mandating the turnover of all donations to DOH but would not allow its use. This is compounded by a requirement for accreditation that includes, among others, an application by the manufacturer or distributor of such health products. Since these are donations and therefore not for business purposes, how in the world will these donors look for local distributors, or look for the manufacturer to file for an application? Sec 4(j) specifically states that all donated health products need only a certification from the regulatory agency/ies of the country that allows the use of such health products for FDA to approve the same.

On the other hand, there is no saying that Secretary Carlito Galvez Jr. is not doing a good job as chief implementer of the government’s national response against COVID-19, by playing catch-up for the inadequacies of some people.

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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).”

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