FDA chief vows to streamline drug approval process; provide cheaper quality medicines

dr Samuel Zacate, Director General of the Food and Drug Administration (FDA), was the keynote speaker at the General Membership Meeting of the Philippine Chamber of the Pharmaceutical Industry, Inc. (PCPI)

The Director General of the Food and Drug Administration (FDA), Dr. Samuel Zacate, vowed to cut bureaucracy and innovate within the agency to support the President’s desire for more accessible and cheaper medicines for Filipinos by ensuring fair competition in the pharmaceutical sector.

Zacate, who was appointed head of the FDA by President Ferdinand Marcos Jr. last August, said the agency is undergoing a much-needed overhaul to become a top-tier regulator.

“The FDA’s long culture of being on the safe side and being in the box is long gone because I’m here now,” Zacate said Tuesday at the Philippine Chamber of Pharmaceutical Industry, Inc. members meeting.

Zacate, Diplomat of the Philippine Society of Venereology and Fellow of the International College of Surgeons, is a public health advocate with extensive experience in medicine and medical consulting.

“I can’t let the president fail. So, I’m telling you now, I’m a man of innovation, I don’t want to be pigeonholed. I’m not keen on the idea that we can’t do anything (about a problem) because anything is possible, especially in science,” he added.

The FDA, a regulatory agency tasked with ensuring the safety, efficacy, and quality of healthcare products in the country, plays a crucial role, especially as global health emergencies — Covid-19 and monkeypox — still pose risks to our healthcare system.

Cheaper Quality Medicines Guaranteed

Zacate also pledged to ensure access to medicines and ease the burden on Filipinos.

“As a doctor, I didn’t realize that there would come a time when it would be difficult for us to access medicines. At the height of the pandemic, we couldn’t even get plain acetaminophen or decongestants that are usually readily available in pharmacies. So I told the President that’s a problem,” he said. He pledged to support the president’s call for a robust local pharmaceutical manufacturing sector to ensure the country’s supply of much-needed vital medicines.

“I always make sure I have plans, but I know my limitations, so I’m asking you to point me to the issues you’re encountering in the industry and we’ll meet halfway.”

Optimized process praised

In this regard, Zacate also assured industry stakeholders that under his leadership, the FDA will ensure that the registration process now becomes more efficient. Both manufacturers and consumers would benefit from this, said the FDA boss.

“Regarding the FDA, they have strict requirements and internal processes, but now I have the power to streamline the internal processes, mainly in terms of payments, assessments and rigid (regulatory) conditions. I’ll do it,” Zacate confirmed.

“For example, we will try to make the import process more efficient. There is an ongoing registration mechanism, I am trying to improvise the information technology system of the Center for Drug Regulation and Research. There will come a time when import will be streamlined,” he added.

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