A SENIOR lawmaker on Sunday called for the immediate passage of a bill creating a separate and independent Food and Drug Administration (FDA) that will screen over 30 potential Covid-19 vaccines.
Buhay Rep. Lito Atienza said FDA has always been under the Department of Health since its establishment under Republic Act 3720 in 1963.
Atienza said he wants an autonomous FDA to screen Covid-19 as well as Dengvaxia vaccines.
“We want a new and totally independent FDA to analyze every coronavirus vaccine tendered, not just to avoid a repeat of the Dengvaxia mess, but to ensure that Filipinos get the best possible immunization in terms of efficacy and safety without any shortcuts,” Atienza said.
“One of the lessons we learned from the Dengvaxia affair is that we have to insulate the FDA from unwanted external pressures, including those that might come from future health officials who are also politicians,” Atienza added.
Under House Bill 1106, the lawmaker wants the FDA to be completely detached from the DOH, whose officials in the past had been accused of meddling in order to expedite regulatory approval of Dengvaxia.
Atienza, however, stressed the need for Congress “to safeguard the FDA’s professional integrity if we want the agency to effectively perform its job of protecting public health against unsafe biological products and pharmaceutical agents.”
The FDA should be “absolutely free from somebody else’s authority,” Atienza said. “For too long, the FDA has been carrying out its mandate, but always under the supervision of the DOH. As such, not only has it taken them far too long to act on issues concerning the safety and efficacy of various food, drugs, devices, vaccines and other materials,” he added.
Around 30 experimental coronavirus vaccines are undergoing the last phase of human trials around the world, including one being developed by the maker of Dengvaxia and with a reported higher efficacy of 70 percent.
FDA Director General Eric Domingo earlier said the agency will likely start analyzing applications for the first vaccines by the second quarter of 2021.
Widespread immunization against the coronavirus is not expected until mid-2021, despite the anticipation of progress in producing available vaccines, according to the World Health Organization.
Under the bill, the new FDA shall be empowered not only to issue cease and desist orders, but to order the ban, recall, and/or withdrawal of any health product found to have cause the death, serious illness or serious injury to a consumer or patient, or is found to be imminently injurious, unsafe, dangerous, or grossly deceptive.
The bill said the budgetary requirement necessary for the operation of the FDA shall be included in the annual General Appropriations Act.