Is the crucial role of the FDA compromised?

AS A MATTER OF FACT - Sara Soliven De Guzman (The Philippine Star) - January 18, 2021 - 12:00am

The Food and Drug Administration (FDA) has a very crucial role to play in the coming days, weeks and months as COVID-19 vaccines begin to enter the country.

COVID-19 vaccines are like precious pearls nowadays. They’re the hottest commodity right now, just like rice a few years back. The controversies of imported rice coming in and being hoarded by top government officials just to increase the prices in the market were insane and unbelievable. Today, the same thing will happen. I’m sure many greedy people out there will try to source their vaccines from different countries, bypass the FDA regulations and use power play, double or triple the price of the drug and impose the use on the public. Watch out DTI!

History repeats itself. Didn’t we have the same scenario during the Dengvaxia heyday? Such enthusiasm brought the former house down when the drug was imposed on all public school students, doubled the price in the market and when disaster struck.

Right now, the public is concerned about the different COVID-19 vaccines available in the market. Comparing the side effects and the costs. For instance, why is the Sinovac vaccine sold at around P3,000 here while in Indonesia it is only sold for P600?

Speaking of Sinovac from China, why is the President so adamant about the use of it when it is still an unauthorized vaccine by the FDA and the second most expensive vaccine with only 50.4 percent efficacy? Why aren’t the FDA or the vaccine czar giving proper advise to the President? Why are they easily swayed when the issues and concern about this drug are very glaring and controversial?

Isn’t the FDA’s role compromised by the insistence of the President on the use of this vaccine? The Senate should do a direct inquiry on the role of the FDA to clarify the roadmap on the approval, acquisition and regulatory protocols of the vaccines. By the way, did the FDA put a control on the influx of fake or low-quality face masks and COVID-19 test kits that are out in the market? The FDA better get a stronger grip on their role. Even with the vaccine czar Carlito Galvez around who procures all the vaccines for the government, the FDA must have the last say. It is during this crisis that we need good and honest men who will protect the Filipinos over the compromises made by this administration.

Don’t forget the FDA has a very crucial role. FDA director general Rolando Enrique Domingo, appointed by President Duterte in March 2020, must maintain his oath to the people. He should remember that this is not about political parties. His role is pivotal to the lives of the Filipinos.

Let’s review Republic Act (RA) 9711, The Food and Drug Administration (FDA) Act of 2009. The major aims of the Act are: (1) To protect and promote the right to health of the Filipino people; (2) To establish and maintain an effective health products regulatory system. Section 4 of RA 9711 has the following objectives: (a) To enhance and strengthen the administrative and technical capacity of the FDA in the regulation of establishments and products under its jurisdiction; (b) To ensure the FDA’s monitoring and regulatory coverage over establishments and products under its jurisdiction; and (c) To provide coherence in the FDA’s regulatory system for establishments and products under its jurisdiction.

In Section 5 of RA 9711 the following functions, powers and duties are stated: (b) To assume primary jurisdiction in the collection of samples of health products; (c) To analyze and inspect health products in connection with the implementation of this Act; (d) 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; (e) 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... (h) To conduct appropriate tests on all applicable health products prior to the issuance of appropriate authorizations to ensure safety, efficacy, purity and quality... (j) To issue cease and desist orders motu propio or upon verified complaint for health products, whether or not registered with the FDA... (o) To prescribe standards, guidelines and regulations with respect to information, advertisements and other marketing instruments and promotion, sponsorship and other marketing activities about the health products as covered in this Act.

Furthermore, Section 12 of RA 9711 states: (a) Any person who violates any of the provisions of Section 11 hereof shall, upon conviction, suffer the penalty of imprisonment ranging from one (1) year but not more than ten (10) years or a fine of not less than fifty thousand pesos (P50,000) but not more than five hundred thousand pesos (P500,000), or both, at the discretion of the court: Provided, That if the offender is a manufacturer, importer or distributor of any health product, the penalty of at least five (5) years imprisonment but not more than ten (10) years and a fine of at least Five hundred thousand pesos (P500,000) but not more than Five million pesos (P5,000,000) shall be imposed: Provided, further, That an additional fine of one percent (1 percent) of the economic value/cost of the violative product or violation, or one thousand pesos (P1,000), whichever is higher, shall be imposed for each day of continuing violation: Provided, finally, That health products found in violation of the provisions of this Act and other relevant laws, rules and regulations may be seized and held in custody pending proceedings, without hearing or court order, when the director-general has reasonable cause to believe from facts found by him/her or an authorized officer or employee of the FDA that such health products may cause injury or prejudice to the consuming public.

Again, this is about our safety and security. Congress should review RA 9711 and further strengthen it. The President and his men shouldn’t brush off the use of unauthorized vaccines by his uniformed men. It confuses the public and has already created negative consequences to established law and order in the land.

In a country already traumatized by vaccines due to the concerns brought about by Dengvaxia, the government must be extra sensitive and instead of being callous, show more concern to our fears. As the old adage goes, “why play with fire?” Pfizer and BioNTech have already been approved by the FDA, why not put our energy on the safer side?

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