FDA should not be under DOH — expert

MANILA, Philippines — A health expert from the National Academy of Science and Technology on Wednesday suggested that the Food and Drug Administration should be removed from the supervision of the Department of Health. 

Dr. Antonio Dans, professor from the University of the Philippines-Manila College of Medicine, said the FDA should be a separate institution from FDA for legitimate check and balance.

“Because there was no adequate separation between policy and science, FDA is under the DOH then we lose the check and balance. FDA should be independent from DOH,” Dans said.

He added: “We hope that the legislation that comes from here should address how the science is assessed. There should be a separation assessing the science and people rendering policy.”

In December 2015, the FDA approved the Dengvaxia for the prevention of disease caused by all four dengue types in individuals from nine to 45 years old.

FDA suspended the sale and distribution of Dengvaxia, four days after the suspension of the dengue vaccination program.

FDA Director Nela Puno said the agency has created a task force who will investigate Dengvaxia controversy.

More than 860,000 people have been vaccinated with Dengvaxia before the immunization program was put on hold December 1.

READ: FDA stops sale of Dengvaxia, orders withdrawal from market

‘Bad science’

During the second day of the Senate blue ribbon committee probe into the questionable dengue vaccine, Dans earlier said that the root of the Dengvaxia controversy started with “bad science.”

He added that there were warnings that Dengvaxia could pose threats to patients with no previous dengue infection but they were initially ignored and were only recognized later on.

“We’re all victims of that bad science. WHO is a victim of that bad science. The DOH is a victim of that bad science. The physicians who ended up prescribing it and the patients who ended up receiving it were all victims of that bad science,” Dans said.

Moreover, Dr. Anthony Leachon, a health reform advocate, said former President Benigno Aquino III could not be blamed if he was fed with the wrong information.

“If the bad science or wrong information has been fed to the president, how can you blame the president if the president was fed with bad science or wrong info? Or even the World Health Organization or even [former DOH] secretary [Janette] Garin?” Leachon said.

He added: “The problem is that when the matter was brought to president, he thought there was a sense of urgency.”