Local government veterinarians have sought the immediate resolution of the conflict on approving authority for African swine fever (ASF) and avian influenza (AI) vaccines as the immediate supply of vaccines will arrest a “national emergency” in meat and food security.
The Provincial, City, Municipal Veterinarians League of the Philippines (PCM-VLP) has expressed disappointment over the conflict between the Food and Drug Administration (FDA) and the Bureau of Animal Industry (BAI) on the approving authority for vaccines.
The conflict has been dragging the worsening ASF and AI infestation in hog and poultry sectors.
“We have long been waiting for this resolution,” said PCM-VLP President Dr. Mary Grace M. Bustamante during the Animal Health Congress last week.
The Department of Agriculture’s (DA) Livestock Group led by DA Secretary Francisco Tiu-Laurel will coordinate with the Office of the President with which a petition for resolution on the conflict has been filed.
“The spread of ASF is now a national emergency concern. There are provinces that have shortages of pork for their citizens. Prices are soaring at wet markets. We need to ensure food security, especially for pork,” said DA Undersecretary Deogracias Victor B. Savellano.
“The approval of ASF vaccines by the FDA is critical to our food security. We have been waiting. I do not know how long we can wait as ASF eats up LGUs who have now been declaring states of emergency.” DA has not procured any vaccines for ASF since there are no FDA-approved vaccines for ASF, he said.
Local government veterinarians are concerned that the FDA lacks the resources and capability to fully undertake the task of approving veterinary vaccines. This, although an earlier memorandum of agreement (MOA) ordered the FDA and BAI to collaborate on regulating such veterinary products.
“FDA has limited people to look after this function. BAI used to do this task as it does have the capability to test and approve (the safety and efficacy) of vaccines. If this conflict is cleared, (then we can work toward ASF-free and avian flu-free status),” said Bustamante.
There is an apparent lack of alignment in the present setup where the FDA approves the commercial release of the vaccine while BAI is the one testing it.
It has been assumed that since some animal drugs are also being prescribed to humans, even vaccines and animal biologics should be approved by the FDA.
However, Bustamante asserted that veterinarians precisely know that animal vaccines are only for animals. “Veterinarians and medical practitioners will never prescribe animal vaccines to humans. This should not then be a concern for regulators,” she said. “We know that antibiotics for animals are only for animals. We know that these vaccines should only be for animals. So why is there a need for the FDA to approve it?” she said.
FDA Advisory 2022-0591 indicated that marketing authorization of veterinary drugs, vaccines, and medical devices will be regulated by the FDA’s Center for Drug Regulation and Research (CDRF).
This advisory was issued apparently during the time of high COVID-19 infections. It complied with FDA Circular 2021-025 or the “Guidelines for Application for Authorization at FDA in light of Extended Stare of Public Health Emergency dated 9 December 2021.”
An earlier Joint DA and DOH Administrative Order (AO 0026) in 2013 indicated that the t FDA “shall continue to register veterinary drugs in pharmaceutical dosage forms except those intended for feeds and license establishments manufacturing, distributing, importing exporting, selling the same.” The AO was effective for five years until sooner terminated. A periodic review of a Technical Working Group should also to to recommend appropriate action.
Under the same AO, BAI will regulate veterinary drugs and products including “veterinary vaccines, diagnostic kits and reagents, veterinary medical devices, and other biological products.” The limited number of veterinarians is also a major concern if the Philippines is seeking ASF-free and AI-free status. However, Bustamante said that under present laws, only provincial governments first-class municipalities are required to hire veterinarians.
“If a local executive doesn’t find the importance of having veterinarians, we really can’t do much about this problem. How about second, third-class municipalities– where hiring of veterinarians is dependent on who the local authority is?”
Dr. Loida M. Valenzuela, the provincial veterinarian of Ilocos Norte, told the same Animal Health Congress that veterinarians should have an independent authority in local government units (LGU). They should not be under provincial agriculturists, considering that veterinary medicine is an entirely distinct professional discipline. Entry-level compensation for veterinarians should also be upgraded, according to Valenzuela. This will encourage fresh passers of the Veterinary Medicine board examination to take on local government jobs.
The LGU veterinarians were regretful of the low passing rate for takers of the Veterinary Medicine board examination. It has been limiting the number of animal experts in local governments. It worsens the already brain drain experienced as veterinarians choose to work in higher-paying private companies, worse abroad.
“Something has to be done about this. This is not favorable for us,” said a veterinarian at the Animal Health Congress.
