"Has the FDA finally seen the light?"
"Has the FDA finally seen the light?"
We have to count our blessings. After weeks of indecision and at times outright rejection on the matter of ivermectin, it appears that Food and Drug Administration Director General Eric Domingo has finally seen the light.
In a hearing presided over by Anti-Red Tape Authority Director General Jeremiah Belgica and attended by Domingo and representatives of the Department of Health, Philippine Society for Microbiology and Infectious Diseases, Philippine Chamber for Commerce and Industry, CDC-Philippines and a number of pharmaceutical companies, the FDA chief agreed to open the doors for the use of ivermectin as both a prophylactic and, after the needed clinical trials, even cure against the deadly COVID-19 virus.
Belgica said in a statement released after the meeting that the following were established and would be undertaken on the matter of this drug: a) compounding pharmacies may now compound ivermectin upon the request and prescription of doctors to their patients. This is a token variation of the compassionate use in medical lingo and FDA’s way out of any ‘responsibility’ as, according to the agency, it is not within their jurisdiction since it will not be bought over the counter which, again, per their rules will require a certificate of product registration (CPR); b) FDA will expedite the application for CPR and/or compassionate use permit (CUP) for ivermectin as an anti-parasitic drug for use on other illnesses long established probably even long before Domingo thought of going to medical school; c) DoH and PSMID to start trials and studies to include ivermectin in the Treatment Protocol for COVID-19 which can hasten the admission of ivermectin for Drug Emergency Use (DEU) or as is advised for vaccines Emergency Use Authorization (EUA).
This development on Ivermectin’s use against COVID-19, if followed through with the same enthusiasm and vigor that is and should be allotted to emergencies such as the one we are in right now is most welcome indeed. The big problem is both the DoH and the FDA have been used to bureaucratic ways that it will probably take a strong kick in the you-know-what by no less than President Duterte to get just the compassionate use regimen out of Domingo’s office, say in a week or so. To think that compassionate use already frees FDA from any liability leaving everything to the patient and his /her doctor yet the agency still charges a fee every time a doctor requests it. And how long does it take for such a permit to be given anyway? Insiders tell us that it takes at least 36 hours if you know somebody in that office.
So if this is the regimen do we have any chance in time for a sizable number of would be users to be given this much needed anti parasitic, prophylactic drug to make a difference in our fight against this deadly disease? But at least Domingo attended the meeting and tried to put on a friendly face in light of the continuing public demand for the use of ivermectin.
But to the dismay of the participants and, of course, a public outraged by the seeming indifference if not outright rejection of the administration’s medical officials of alternative treatments for the ravaging COVID-19, the FDA and the DoH are now again trying their very best to walk back on their promised actions to get Ivermectin to the hands of an exhausted public no matter how iffy those promises were. “Promises nga eh” — as one participant told us.
Imagine, instead of saying that ivermectin has been in use as an anti-parasitic drug for various diseases and was actually widely used in the country for annual deworming of children and, I am told, even for adults during the time of then President Marcos up to Health Secretary Johnny Flavier, the FDA and the DoH had to issue a last minute advisory saying that “all current ivermectin products registered in the country are for veterinary use and are only allowed for the treatment of internal and external parasites as well as prevention of heartworm diseases of animals..”
While this may be the case for now this does not erase the historical record of Ivermectin’s human use. Better still and more accurately, it does not preclude the issuance of the clear WHO guidelines that it is an anti-parasitic drug used for various illnesses if Domingo and his ilk were as concerned as a lot of public health practitioners and medical experts are about the public welfare. But no. Instead of raising all kinds of neither-here-nor-there, “not for or against” statements they chose to lend themselves to the skeptics and the naysayers whose only concern seems to be the continued enslavement of our people to interest other than the public’s welfare. Sayang. And we thought we were to have some good news after more than a year of bad ones.
