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Vaccine row shows need for independent FDA

We can only commiserate with former Health Secretary Janet Garin. The former Department of Health (DOH) head has become deeply mired in a major controversy surrounding the dengue vaccine Dengvaxia sold to the government by beleaguered France-based pharmaceutical giant Sanofi Pasteur.

It would be unfair to ascribe malice nor wrongdoing on the part of Garin without due process.

It is good that the Senate Health Committee jointly with the Blue Ribbon Committee are set to start a probe today.

That should help shed light on the role that Garin played in a controversy that has given millions of parents a big scare concerning the health of their vaccinated children.

Spotlight will be on Garin when she is grilled on the important questions regarding this controversy.

Long before the disclosure done by Sanofi laboratory researchers that the vaccine may have adverse effects on children who have not had dengue prior to the immunization, many have already begged for an answer to one nagging question: why was the procurement process for Dengvaxia completed in record time and at unprecedented speed?

If we recall correctly, last year’s probe on this row revealed that the past administration may have consummated the deal with Sanofi in less than half a year.

This is unheard of in this country. Compounding the issue are reports that the purchase of the Sanofi vaccine was never in the 2014, 2015 and 2016 programs and budgets of the DOH, and that there was a rush to secure funding for the purchase from government savings.

The suspicions regarding this speedy deal has been aggravated by the fact that the amount involved P3.5 billion-plus in taxpayers’ money.

Garin may also be asked regarding the steps taken by the past administration to ascertain the safety of a drug which appears to be untested.

She will also have to explain the haste with which the past administration seemed to have done two things: first, the mass immunization of our schoolchildren in public schools; two, the payment for the purchase of this questionable vaccine from Sanofi.

Other than these, Garin will have to address one more question: did she not name herself as acting and concurrent director-general of the Food and Drug Administration (FDA) at the time that the Sanofi vaccine was being discussed and approved for purchase by this agency?

Again, we are not ascribing any malice here, but if the answer is yes, then Garin will have to explain that questionable situation.

Here’s why. The FDA is a regulatory agency. While it is attached to the DOH, the FDA evaluates, approves and certifies the drugs purchased by the health department and which the latter distributes through its nationwide network of health centers.

There assumption here is that the FDA acts independently and without undue interference from the DOH when it does the evaluation and certification.

That assumption has been put under serious question by the fact that when Dengvaxia was approved by the FDA, the then-DOH Secretary was also the chief of the FDA or appointed an underling as officer-in charge.

It will be good for Garin to shed light on this particular issue.

If there is anything that should come out of that Sanofi probe, it should be a law making the FDA a totally independent regulatory agency accountable to the Office of the President ( OP).

It should be detached from the DOH which the FDA actually regulates. A possible setup can follow the regulatory model of the energy sector. There, the Energy Regulatory Commission (ERC) is independent from the Department of Energy (DoE) and the DoE Secretary is not part of the Commission.

The DOH is the biggest buyer of pharmaceutical products in the country. It uses taxpayers’ money in the process.

The FDA is the only check in this procurement process. The DOH cannot consummate the purchase without the evaluation and certification of the products by the FDA.

The transparency of this procurement process will always be doubted unless the FDA is completely freed up from its dependence on the DOH.

As things stand today, even the FDA’s budget and the appointments of its key personnel are under the control of the DOH Secretary.

How can an agency whose funds and key officials are under the control of another exercise regulatory powers over the latter?

Senator JV Ejercito has already filed Senate Bill No. 1631 to amend the FDA Act of 2009 and place the agency directly under the OP.

We hope that the Senator’s timely initiative would be supported by his colleagues in Congress so that something good would come out from this Dengvaxia controversy.

This is an opportunity to beef up the protection we provide to our people, particularly to our children. This is also a chance to strengthen the ways we protect our people’s money.

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