FDA reforms scaring some insiders?

IF the new director general of the Food and Drug Administration (FDA) wants to pursue the reforms she has initiated in the agency, she better learn to watch her back.

It looks like some big business interests are not happy that these reforms are loosening their stranglehold on the FDA, and their lackeys inside the agency are reportedly plotting a demolition job against her.

Word is going around that some powerful interests in the pharmaceutical sector are looking for “media allies.” This is reportedly in connection with an orchestrated move to get current FDA Director General Nela Charade Puno out of her post.

Puno should not take this lightly. The reforms at the FDA have apparently hurt the “underground economy” involving some insiders and have adversely impacted the even bigger economic interests of some industry giants.

Reports say a move by Puno to prohibit direct transactions between FDA officials and employees with external parties has triggered a silent howl. It appears Puno has required industry players and those applying for FDA permits and certificates to course their requirements through a central receiving desk. It is that desk which fans out the documents received from external parties to the proper department within the FDA.

Puno should realize that she has just jeopardized a “major industry” in government offices called “facilitation.”

It is a fact that the so-called facilitation fees in many frontline government offices bring in bigger revenue to “facilitators” compared to what they officially receive by way of government wages.

It appears this is the very same FDA policy which placed a senior FDA official in hot water.

This FDA official reportedly violated the rule and directly received a computer device that contains electronic information from a courier of a major international business interest. The said official publicly admitted the act and insinuated that the intended final recipient of that fatal USB was Health Secretary Francisco T. Duque III himself.

Duque sacked the official a few days after that incident.

Another move that has reportedly roused the ire of some FDA officials against their director general was the latter’s move to form a Task Force to audit the certificate of product registration (CPR) issued for the dengue vaccine, Dengvaxia, during the past administration.

Puno’s Task Force has reportedly made some key FDA officials nervous since a number of them may have played crucial roles in the approval of that CPR.

Puno created that Task Force in the wake of her own assessment and declaration before the Senate Blue Ribbon Committee that the process of approving the CPR for Dengvaxia had been “hasty.” Puno should expect that those who were part of what she claims to be a hasty approval process should now want her out and get even with her.

There are concerns that the oust-Puno move is actually being backed—financially and morally—by big business interests.

This is not surprising. We were told that Puno had been rather “unaccommodating” when it came to big business interests. Her campaign against counterfeit food and health products  also  earned for Puno the ire of these companies.

We recall that one particular big company had already mobilized its media mouthpiece—a foreigner who has always kibitzed on local issues—to question the wide coverage of the FDA’s regulatory powers.

This same foreigner who had always championed big business interests here now appears to be leading a multi million public relations blitz in defense of a beleaguered and controversial pharmaceutical product and to undermine the accomplishments of FDA under Puno.

In fairness to Puno, her reforms at the FDA appear to have  gotten the backing of Duque.

Duque’s support is crucial to these reforms. By her lonesome, we doubt if Puno can withstand a well-funded campaign against her by the vested interests that her reforms have disadvantaged.

Duque’s move to back these reforms are already paying off.

For one, we heard that the FDA has gotten an ISO certification recently.

This means its processes conform to global standards of transparency, efficiency and sound management.

If we correctly recall, these have also been the same standards Duque had advocated for the government sector  when he was the chairman of the Civil Service Commission.

It will be interesting to watch how this alleged big business-backed PR efforts against the FDA head would prosper.

It may have gotten the support of some disgruntled FDA insiders.

We doubt if that move will get public support.

 

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