We have beefed up the military, to protect the country from external and internal threats. We have beefed up the national police, to fight crime and to go after illegal drugs. But, have we beefed up the agency that fights the most important fight — protecting people from the potential if not fatal harm or damage that can be caused by everyday products, food and medicine included?
I raise this point in light of a number of things: the reported approval in December 2015 of the Food and Drug Administration (FDA) of the controversial Dengvaxia vaccine against Dengue; the mandate that Congress intends to place on the FDA to measure the sugar content of sweetened beverages for purposes of taxing them; and, potential conflict of interest of the FDA leadership.
In fairness to FDA, 10 days ago it ordered the pullout of Dengvaxia. This was after the release of information that the vaccine can also cause some harm.
In Advisory No. 2017-318 dated Dec. 4, FDA Director-General Nela Puno said drug maker Sanofi Pasteur should “immediately…suspend the sale/distribution/marketing of Dengvaxia and cause the withdrawal of Dengvaxia in the market pending compliance with the directives of the FDA.”
While quick preventive action has just been taken, the fact of the matter is, two years ago FDA itself — under a different administration — approved the vaccine, on which basis the product was commercially launched in the Philippines in early 2016. It is a fact that Dengvaxia could not have been sold and launched in the country back then, if the FDA hadn’t approved it.
And this brings us to the question of whether or not FDA, to date, is strong and capable enough, and independent enough, and truly technically competent to resist political and economic pressures with respect to fulfilling its mandate of protecting the consuming public from potential harmful effects of everyday products?
I would have to say that much still needs to be done in terms of making FDA a truly reliable, dependable, and credible institution. Structurally and functionally, it should be free from interference from the Department of Health, and its head, while a presidential appointee, should be vetted exhaustively in terms of academic and professional qualifications and technical competencies.
Its personnel should be trained, with required mandatory continuing education, and its equipment and facilities improved to ensure that only the strictest health and safety standards are used in the approval and regulatory processes.
Moreover, the agency and its head should also be made more accountable, and perhaps liable, for bad calls.
Republic Act 9711 created the FDA in 2009, having renamed the former Bureau of Food and Drug.
To date, the FDA remains under the Department of Health. Its head is a presidential appointee. Further, Section 7 of the law states, “The [FDA] director-general shall, preferably, possess either a university degree in medicine or at least the relevant master’s degree in pharmaceutical sciences or allied sciences, or equivalent executive course in any regulatory management.”
The same section also states that, “a person who was previously employed in a regular full-time capacity regardless of its consultative designation at higher management supervisory levels in regulated establishments, including related foundations, shall be disqualified from appointment as director-general and deputy director-general within three (3) years from termination of employment with the said establishment or foundation.”
Where Congress failed, in my opinion, is when it premised the FDA head’s legislated list of qualifications as simply “preferred,” rather than actually requiring them.
Thus, under the law, the agency may actually be headed by someone who does not possess any of the qualifications stated, like a medical degree or a “master’s degree in pharmaceutical sciences or allied sciences, or equivalent executive course in any regulatory management.
In the case of the present FDA head, I don’t think she has any of the qualifications stated above. And this is actually fine, under the law. Also, I have read that she ran her own cosmetics business in the past — a company regulated by FDA. I am uncertain, however, if she meets the legally required three-year holding period — that she cannot be appointed to FDA “within three (3) years from termination of employment” from such a regulated establishment.
But, this is not about the present FDA head or her qualifications. This has more to do with whether FDA, at present, is ready to deal with situations like that caused by its Dengvaxia approval of 2015.
In fact, even in terms of sugar content measurement, if memory serves me, FDA had informed Congress that it was incapable of such task at present.
Given such, why should Congress even give them that mandate?
The FDA is a front-line agency with respect to protecting consumers, and ensuring public health and safety. And yet, it doesn’t seem to enjoy the focus, attention, and resources it requires to effectively fulfill this mandate. That it was perhaps prevailed upon or pressured to approve Dengvaxia in 2015 is proof of this. Only for the agency to backtrack two years after — with public damage already done.
Can FDA — or, at least its previous head — now be held accountable, and perhaps liable, for the 2015 approval? Again, as I understand things, Dengvaxia could not have been commercially launched in the Philippines in 2016 without FDA approval in December 2015. Suspension of sale and distribution now is just a preventive measure. Meantime, the vaccine has already been administered to hundreds of thousands of adults and children despite concerns regarding it.
Incidentally, the US FDA had total resources of about $4.9 billion in 2016. Moreover, the US FDA is presently headed by a Commissioner Scott Gottlieb, who is a physician, medical policy expert, and public health advocate who previously served as FDA Deputy Commissioner for Medical and Scientific Affairs and before that, as a senior advisor to the FDA Commissioner. He was a senior advisor to the Administrator of the Centers for Medicare and Medicaid Services, and had served on the US Federal Health Information Technology Policy Committee. He was a Resident Fellow at the American Enterprise Institute, and a Clinical Assistant Professor at the New York University School of Medicine in Manhattan. And other than a medical degree, he also holds a degree in Economics.
The resources dedicated, and the qualifications required, indicate the seriousness and importance of the US FDA and its task. This is perhaps considering that more people may die of sickness and accidents — which can be mitigated by an FDA properly and diligently and efficiently doing its job — rather than war or crime or illegal drugs combined.
Can we not give our own FDA the same level of support and attention? Should we not level up our own FDA to better protect public health, safety, and welfare? Should we not demand more from our FDA and its head and its people? Should we not make our FDA more accountable if not liable for approvals that end up endangering rather than protecting the public?
Marvin A. Tort is a former managing editor of BusinessWorld, and a former chairman of the Philippines Press Council.