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

Food and Drug Administration (FDA) Director General Dr. Samuel Zacate vowed to remove red tape and introduce innovations within the agency in support of the President’s desire for more accessible and lower-priced medicines for Filipinos by ensuring fair competition in the pharmaceutical sector.  

Zacate, appointed by President Ferdinand Marcos Jr. to head the FDA last August, said the agency would undergo a much-needed overhaul as it gears toward becoming a world-class regulatory body. 

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

Zacate, a diplomate of the Philippine Society of Venereology and a fellow of the International College of Surgeons, is a public health advocate with years of expertise in medicine and medical consultancy.

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)

“I cannot let the President fail. So now, I am telling you, I am a man of innovation, I don’t want to be inside the box. I am not keen on the idea that we cannot do something (to a problem) because everything, especially with science, is possible,” he added. 

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

Cheaper quality medicines assured 

Zacate also vowed to ensure the accessibility of medicines and make it less burden on Filipinos.  

“As a physician, I did not realize that there would come a time when it would be hard for us to access medicines. During the height of the pandemic, we could not even get simple paracetamol or decongestant, which are usually readily available in pharmacies. So, I told the President that this is a problem,” he said. He vowed to support the President’s call for a robust local pharmaceutical manufacturing sector to ensure that the country’s supply of much-needed essential medicines.

“I always make sure to have plans but I know my limitations, that’s why I am asking you to bring up to me the problems you are encountering in the industry and we will meet halfway.”  

Streamlined process vowed 

Relatedly, Zacate also assured the industry stakeholders that under his leadership, the FDA will ensure that the registration process will now be more efficient. In doing so, the FDA chief said both manufacturers and consumers would benefit.  

“With regard to the FDA, they have stringent requirements and internal processes, but now I have the power to streamline the internal processes, mostly on payments, assessments, and rigid (regulatory) conditions. I will do it,” Zacate affirmed.  

“For example, in terms of the importation process, we will try to make it more efficient. There is an ongoing mechanism for registration, I am trying to improvise the Information Technology System of the Center for Drug Regulation and Research. There will come a time when importation will be streamlined,” he added.   

ADVT.