‘Dr. Stranger’

More than 50 percent of consumer products in all Filipino homes undergo some form of screening, testing or review by the Food and Drug Administration. There is no doubt that among the gatekeepers or regulatory agencies in all countries, the FDA is one of the most vital and under-appreciated.

It was only during the COVID pandemic when FDAs around the world received both positive and negative attention and when people began to understand what such an agency does, why it does it and of course the consequent red tape or delays that crop up. It was also between 2020 and 2021 when many Filipinos realized how underfunded the FDA was.

Just to refresh your memory, here are just some of the vast responsibilities of the Philippine FDA:

• To establish safety or efficacy standards and quality measures for foods, drugs and devices and cosmetics and other health products;

• To undertake appropriate health manpower development and research, responsive to the country’s health needs and problems;

• To assume primary jurisdiction in the collection of samples of health products;

• To analyze and inspect health products;

• To establish analytical data to serve as basis for the preparation of health products standards, and to recommend standards of identity, purity, safety, efficacy, quality and fill of container;

• To issue certificates of compliance with technical requirements to serve as basis for the issuance of appropriate authorization and spot-check for compliance with regulations regarding operation of manufacturers, importers, exporters, distributors, wholesalers, drug outlets and other establishments and facilities of health products, as determined by the FDA;

• To conduct appropriate tests on all applicable health products prior to the issuance of appropriate authorizations to ensure safety, efficacy, purity and quality.

Because of underfunding and the related overreach in responsibilities, the FDA has been susceptible to bureaucratic red tape, poor performance and a tendency to create bottlenecks and delays. Even the appointment of a relatively young physician named Dr. Samuel Zacate has not won over fans for the FDA.

The column today is entitled “Dr. Stranger” because physicians, health advocates as well as a few scientists essentially described Dr. Zacate as the epitome of “A Stranger in a Strange Land.” One respected scientist and member of the academe related how all efforts to assemble a biodata on DG Samuel Zacate proved challenging and futile because barely anything was available online or on the grapevine.

Either he is a very private person or has scrubbed all online info for security reasons. A recurring theme or description of DG Zacate is that he hails from somewhere in Ilocos and was appointed by President Marcos Jr.

I tried to do the same but the only things that kept popping up were videos from the state information agency and related features but not much on Zacate’s educational and professional background.

It may interest the director general that many of his colleagues and fellows in the field of public health would like to know more about “what qualifies him as director general, given the vast scope of serious responsibilities of the FDA” and what he intends to do about delays in registration, testing and approvals where the Philippines allegedly takes longer to test than neighboring countries.

This problem ends up delaying the availability of products, particularly important or essential medicines that are needed in the treatment of serious illnesses. As an example, one of my friends had to ask relatives to buy a medicine for Adult Late Onset Leukemia in Taiwan or Malaysia because the drug was not approved in the Philippines.

To be fair to DG Zacate, he carries himself well in press conferences and he seems to pick up on “issues of interest” for the general public and media. However, he is not scoring points by keeping stakeholders at arm’s length and being disengaged with various bodies and boards for science, medicine and the academe.

By coincidence, several doctors and scientists who read my column last Monday titled “Fire starters and careless conclusions” noted my frustration about how the Dengvaxia vaccine was run out of town through hysteria, the DOH officials involved have been charged not with corruption but homicide and how 700,000 “patients” were never monitored, observed or recorded for scientific data and research. The FDA should have gathered and stored all that scientific data!

Our reader MDs and members of the academe informed me that there has been a long pending application for a new dengue vaccine that has been pending at the DFA for “13 months” or over the prescribed period of testing/approval. In the opinion of those readers, director general Samuel Zacate is being protective of President Marcos Jr. for fear of another Dengvaxia scandal.

As a political appointee of the President, I can’t fault DG Zacate. But I would boldly suggest to the director general to be as much a scientist and physician in weighing matters. Protecting the reputation of the President cannot be in exchange of a life, pain, suffering or financial loss of a Filipino child, parent or senior citizen due to dengue.

As a physician, DG Zacate knows that dengue will be a perpetual, perennial medical threat in the Philippines. As a doctor, DG Zacate, I am sure, appreciates the facts and science behind vaccines. As a government official, it is now incumbent upon DG Zacate to review and compare the Philippine experience with the regional and global experience concerning the efficacy and necessity of use of vaccines, both Dengvaxia and the current product under application.

Last but not least, allow me to share with DG Zacate the proverb: “There is wisdom in the counsel of many.” Doctors, scientists and health advocates as well as private sector stakeholders may not belong to the political party, but they are taxpayers who deserve your time and respect.