Criminal delays

Damned if you do damned if you don’t. That was how several executives describe their situation in dealing with the Food and Drug Administration of the Philippines or FDA. According to my various sources any individual, company or business group who wants to sell or export a medicinal or food-based product has to go through the FDA for evaluation, clearance or approval or all of the above. Many local and international pharmaceutical companies uniformly describe the process as something that takes as long as six months or half a year to get an appointment/booking for a presentation and an average of 18 months to two years to get approval IF you are lucky. But that was then. In spite of the FDA’s radical issuance of CSPs or Compassionate Special Permits and EUAs or Emergency Use Authorizations, it turns out that the conduct of business and the speed of service for regular businesses has become slow and unbearable.  

Unbearable enough for many companies to pile up complaints on some 2,300 applications for renewal of registration, and angry enough for several pharmaceutical companies both local and international to send lawyers and representatives to the Anti Red Tape Authority to present their case. Fortunately, the director general of the ARTA DG Jeremiah Belgica has a trait similar to a Blood Hound, once you give him an article to act on he immediately goes on the hunt. In the case of the FDA, it was so unbelievable and frustrating for Belgica that it nearly drove him to tears just explaining how bad the situation was when I interviewed him on AGENDA. 

Setting aside new and unapproved applications at the FDA, Director Belgica investigated applications for RENEWAL of registration/licensing of products already approved in the past, established and currently used or sold in the market and have proven records. These covered applications from 2013 to present and totaled 2,300 initially. To expedite matters, DG Belgica sat down with people at the Center for Drug Regulation and Research (CDRR) and they agreed on how to simplify the process by cutting requirements down to three. From there, Belgica was given the impression that this particular concern had been addressed. But when Belgica crosschecked with company representatives, what he got in return was a minimum of 600 affidavits of complaints attesting that no such resolution or re-registration took place.  

You, as a reader, may not think much of the issue because you think it does not affect you directly or because you think the FDA covers only medicines. No, they cover medicines for both humans and animals, domestic or agricultural, they cover food products and the likes as well as “devices.” If the registration of any of those products are held up or “inipit,” as DG Belgica described the situation, then suppliers cannot distribute, dealers and stores cannot sell, doctors and veterinarians can’t prescribe and many of us won’t be able to buy or use what we have already been using for years. Whether it’s an Over The Counter (OTC) medicine for you or your dog, cat or chickens, it has to have the FDA registration.  

But that is just for FDA approved pre-existing products in the market. The ARTA has not even gone deeper into highly specialized medicines or products intended to address cancer, diabetes, pediatric products for critical care, etc. One pharmaceutical leader told me that it may come as a shock not to find those medicines in the Philippines and it explains why many Filipinos resort to buying those medicines abroad. The FDA simply established the industry belief that new breakthrough products will be better off sold abroad and in the region than waste time, money and opportunity waiting and praying for the FDA to realize that they have a need for speed. 

As far as the ARTA director general is concerned, what the FDA establishment needs is a “lifestyle check,” particularly those under the CDRR. When I raised the point that the FDA-CDRR, like most government institutions, are undermanned and under funded, Belgica pointed out that the FDA shares the same situation as all government offices. But when delays or inaction goes all the way back to 2013, it is no longer excusable and is unforgiveable. As such, the FDA-CDRR was given a show cause order. Given all of the above, the CDRR people should pray that President Duterte does not read or find out about this deplorable dirty secret at the FDA. Or maybe, DG Belgica should bring the matter to the President. Maybe in that manner, he can eliminate any possibility of coddling or protecting the guilty inside the FDA, which is under the DOH. 

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Once again, Secretary William Dar and Bureau of Animal Industry Director Morales have reassured us that the DA stands committed and will pay out the indemnification payment owed to all backyard hog raisers who followed government guidelines by culling their pigs affected by the African Swine Fever. The only hitch is it all depends on when the DBM or Department of Budget Management will fork over the funds.  On the two occasions I interviewed the DA officials I got the impression that the turnover of funds is not a priority of the DBM in spite of the fact that these outstanding payables go as far back as one year to six months ago.  

This delay is something I certainly intend to bring up with the ARTA soon because not only is the non-payment an un-kept promise of government, it also serves to discourage hog raisers from believing the promises of the DA that future losses will be covered with a higher indemnification through the Philippine Crop Insurance Corporation. As the saying goes: Fool me once shame on you – fool me twice shame on me. Or should it be: Put your money where your mouth is.

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