There are silent problems with this national government agency. And the public has to know.
- FDA has two versions of its website — old and new.
What should be a government agency be so hyped about with the launching of its “new-and-improved” website when it is obviously not ready? I mean, just look at it:
I think what we need the most is an efficient website — the one that contains updated and organized documents, and does not crash. It’s a downer that E-portal and F5 (shortcut key to refresh page) are seasonal best friends.
We need a website that is fast, secure and reliable anytime. I appreciate that the FDA took it among themselves to make a beauty upgrade, but WIKI, functionality and user experience should be a priority. What is face-value when the rest of the body is not working, right?
They should have just fixed the previous issues with the old website first, then consider a make-over when necessary. For now, I’ll be clicking the “Visit the Old Website”. I like meat more than skin anyway.
2) The Philippine Law and the FDA do not seem to sync with each other.
Implementing Rules and Regulations of RA 10918, or the New Pharmacy Law, clearly states that “A pharmacist working in a Category A establishment may be allowed to simultaneously work or render pharmacy services in Category B establishments..” under circumstances.
Unfortunately (and surprisingly), the FDA has “not yet set the guidelines on the licensing of drug establishments following the new law” and that they “still follow the previous guidelines wherein a pharmacist must only have a direct and immediate control and supervision in a single drug establishment.” So this means that no matter how compliant you are to the sections of such IRR, the FDA will surely hand you a Letter of Disapproval.
Well, common reaction would be: Wow. How could something be passed into law when the agencies involved with it are not ready? I can’t even..
There goes your initial application fees for each Retail Outlet For Non-Prescription Drug (RONPD).
[IMO, they should have at least consider refunding the fees or allow you to change the pharmacist-in-charge if he/she handles two categories since people are not well-informed of the FDA’s unpreparedness. Fair enough?]
3) The APPROVAL-DISAPPROVAL scheme is not a win-win situation.
Starting last March 16, the FDA’s Center for Cosmetics Regulation and Research (CCRR) will immediately disapprove applications with incomplete documentary and technical requirements. This means that we will no longer receive Notice of Deficiency (NOD), but will automatically receive a Letter of Disapproval.
Again, there goes our application fee.
Regulatory Officers know it — there is a disease called Inconsistency in the evaluations. There is no absolute here. Meaning, sometimes you can just pray for your application to successfully go through; by hoping that an evaluator misses to see the mini-errors, or hasn’t read all the AO’s, EO’s, Circulars, etc. An application with the exact same situation and submitted requirements may receive a check from Evaluator0001 while fail according to the judgment of Evaluator0002.
A person nicknamed Lin bravely commented to such announcement.
Hats off to you, Lin.
Bottomline is, why is the FDA expecting so much from the industries when they are in great chaos among themselves? They already have a Guideline on Unified Licensing Requirements. Hmm, I wonder if they also have a Guideline on Unified Decision-Making.
The agency boasts its thrust for “Zero-Backlog” which should be in the interest of better public service. Well, I don’t fully buy it unless they really show valid and concrete results.
The way I see it, the reason why the FDA are inconsistent themselves is that their very rules and guidelines are not well-defined and lacking. Any person can conveniently avoid the penalties (or impose it to another) by bending the rules that are bendable by nature.
4) Some applications are sitting with them for YEARS. Worse, the FDA is not keeping up with trends.
Don’t get me started with the amazingly fast-tracked Dengvaxia vaccine approval. (How on earth.)
If the FDA already expressed its intention on applying the Zero-Backlog scheme to other Centers besides CCRR, they should know that speed should not compromise quality. Even the rabbit and the turtle taught us that.
Are they suggesting it to be key to better public service? I’ll give them a chance to prove it.
But for now, industries are still checking the DocTrack for years, hoping to finally receive the Certificates of Product Registration, along with other acknowledged documents. The FDA gave out the timeline for each application process but then again, they break or bend it. A Request Letter for Follow-up does little to no help either.
I guess we are simply stuck with this broken and flawed system. *sigh*
Another thing, there are trendy or innovative product lines (e.g. anti-pollution beauty products, cosmeceuticals, and the ambitious Cellular & Gene Therapy Products like Purtier) emerging in the foreign market that need to have specific guidelines if we are to follow suit.
Are you ready, FDA? How ready?
5) No matter how cliche it may sound, Government must display and aim for excellence and competency.
Look at Health Canada website. (www.hc-sc.gc.ca)
This is what a government website should be: highly-informative, updated and reliably fast. FDA Philippines should consider taking an example from it.
Dear Canadians, let us marvel at your system.
It clearly states what doses are allowable for each specific active ingredient.
Plus, they tell you clearly which statements to put on product labels on certain cases.
Oh yes. Look at that last update. February 21, 2018. Now that’s decent-recent.
I leave the rest of the awe-searching to you. My point here is, our local agency has many rooms for improvement to fill-in. It’s not going to be easy for them but it definitely is their job.
So why are we so hyped with Canada’s health site?
Imagine this: You have all the information that will guide you in the registration of your product. You know the limits, the rules…almost everything. What happens when you know these? You get to be so prepared, you’re almost sure that your product is compliant and will pass the registration process if you follow them all, with full conviction. Otherwise, you can rally with a reason against the regulating body. The facts will decide for themselves. You are saving time and money while yourself from doubt. Rules and regulations that are well-defined will prevent inconsistency. And that is a good thing.
I know that this article may pose issues, but hey, there are issues. Real and hard-to-swallow ones. The FDA already knows. It’s time for the public, too.
Feel free to comment and criticize. An open-minded conversation is a fruitful one. Clap if you find it engaging and stimulating. Thanks!
