Incompetence at the FDA

"No wonder Puno was removed."



President Rodrigo Duterte’s trip to Japan, with over 200 Cabinet officials, staff, security, communications group including his partner and daughter, was truly a junket.

I have joined many presidential trips during the Ramos, Estrada and Arroyo administrations. But this one takes the cake!

To think that the President has fired many officials for “excessive trips abroad.”

I wonder how much the people had to pay for that Japan trip, considering that Tokyo is one of the most expensive cities in the world.

* * *

Former Food and Drug Administration chief Nela Charade Puno was first appointed in 2016, there were praises all throughout the private sector. After all, Puno was the first licensed pharmacist to head the FDA. She is an industry veteran—indeed a qualified professional.

Given this, Puno should have known what reforms the agency needed, its priorities and concerns, and how it could act for the collective benefit of the industry, consumers, and the public in general.

But those praises, I heard, soon turned into jeers. This culminated with her unexpected dismissal from the FDA. It was met with a unanimous sigh of relief, my gulay!

How exactly did Puno fall from grace in the eyes of pharmaceutical players?

The FDA is naturally one of the more unassuming government agencies. Its responsibility is to ensure the well-being of the Filipino people by guaranteeing the safety, quality and efficacy of products. In order to do so, businesses coordinate with the agency to acquire various accreditations such as Certificate of Product Registration, Good Manufacturing Practices certificates for their industrial procedures.

Part of ensuring the safety of the public is to make sure that potentially life-saving and cost-efficient products are made available as soon as possible.

Unfortunately, under the recent leadership of former Chief Puno, thousands of CPRs and GMP certificates have waited as many as six years to be approved.

Don’t forget that the development of a single product can cause millions of pesos. The absence of even just one accreditation can paralyze the establishment.

Small wonder business leaders are thankful for her removal.

It would be easy to say that private institutions are just making excuses for their own shortcomings. Supporters can even say that it’s the FDA’s job to be strict. However, there is a difference between being meticulous and simply dragging one’s feet.

The FDA must not only weed out the bad but ensure that the good goes through.

The thing is, companies have been willing to comply and are capable of complying with normal FDA requirements, Recently, they have been struggling to confirm to the absurd guidelines and demands of the agency’s inept employees and private institutions.

A blatant manifestation of this incompetence was when the agency upgraded its computer system. Somewhere along the way, it lost volumes of crucial documents that they themselves required from the private institutions.

For many companies,this meant going back to square one after years of painstaking red tape. Some pharma companies were actually forced into bankruptcy because of this blunder.

Ultimately, of course, there is much more than money at risk. It is ironic to think that the FDA’s incompetence had aversely affected the health of Filipinos.

Puno’s replacement will, I hope, be a much better appointee. The President must name somebody familiar with the industry and the legalities surrounding it.

* * *

When I saw that photo last Sunday of the half-naked convicts at the Quezon City jail, I was no longer shocked.

Had President Duterte seen such photos? This is not unique to Quezon City. Almost all jails are like this for lack of space.

And if you are shocked at what is happening in city jails, try going to the provinces. The food allocation for each inmate is P50 a day.

If people are not outraged at such a sight, I don’t know what will outrage them.

I am appalled at what seems to be apathy among those in government. The Justice department, through Secretary Menardo Guevarra should do something!

If city and municipal jails are congested, the New Bilibid Prison is another story altogether. It was built for just 4,000 inmates but now houses 24,000.

I wonder what happened to the plan to relocate it to Nueva Ecija.

Mr. President, I implore you. Please look at the sorry state of our jail system—and do something about it.

Topics: Rodrigo Duterte , Japan Trip , Food and Drug Administration , Nela Charade Puno , Department of Justice , Menardo Guevarra
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