MS. OSEÑA-PAEZ: Magandang umaga, Malacañang Press Corps. Welcome sa ating press briefing ngayong araw, February 13th.

In today sectoral meeting, President Ferdinand R. Marcos Jr. directed the Food and Drug Administration (FDA) to continue streamlining the country’s drug regulatory processes with the aim of lowering the prices of true generic drugs and speeding up the process of registering new common drugs,

On veterinary vaccines, President Marcos directed the FDA and the Department of Agriculture to address the issues of work delegation in order to approve the necessary drugs for Avian and African Swine Flu. President Marcos stressed the urgency of veterinary vaccines as this may affect t our country’s agriculture and nutrition needs.

The president also encouraged the establishment of a pharma-zone to make the make the drug application process more accessible and efficient like a one-stop shop, and directed the said agencies to focus on amending the Administrative Order 67 from 1989 to look into allowing foreign common drugs to come in, again, with the intention of bringing prices down for all Filipinos.

And to tell us more about this, we have with us today Director General Samuel Zacate and Director Jesusa Joyce Cirunay of the Food and Drug Administration. Good morning.

FDA DIR. GEN. ZACATE: Good morning to all of our friends in the media and sa mga nakikinig po sa atin, sa mga sambayanang Pilipino. I’d like to confirm that the president has directed the Food and Drug Administration to further streamline the drug application process in the Philippines and to provide further drug accessibility for all the Filipinos, and in the future, the cheaper medicine for us to be accessible also to the Filipino people.

As of now, in the FDA, we already had formulated several policies para po makatulong sa ating mga stakeholders, and one of that is the bible of the drug application process which is the Administrative Order # 67, it will pave the way for the application per category so that the stakeholders, the local drug manufacturers and the drug importers will have the proper way of how to register their products.

Furthermore, we are already having the policies to lengthen the validation or the validity of the license to operate and the certificate of product registration from the initial three years to five years renewal; now, it will be increased to five years initial and ten years renewal. It will help further the stakeholders for the drug to further their business interest and to strengthen the drug accessibility in the country.

Another is that we are doing the revision of fees for us to be capacitated so that our laboratory and testing abilities will be further and be at par with other international regulations.

Another is that we tackled in the sectoral meeting the possibility or the establishment of the pharma-zones, so ano po ang importansiya po nito? It will give a more drug accessible to those selected three pharma-zones by the PEZA. So it will have a role, the FDA will have a role so that pagpasok po ng isang gamot, diretso testing, diretso registration para po magkaroon po ng mabilis at malaki ang lawak ng coverage especially those essential medicines, like for example the generic drugs and the antibiotics that has been approved by the stringent regulatory authority of the different countries.

Aside from that, I would like to also confirm that we already talked with the secretary of the Department of Agriculture, Secretary Laurel, that we will have the JAO, the Joint Administrative Order, so that the veterinary vaccines ‘no, kung alam ninyo po kasi it has greatly affected the meat industry, the supply of the meat industry in the country especially the pork. So, one of the solutions of that is that we give the Filipino people, the stakeholders for the veterinary, iyong mga agricultures natin the vaccine, the technology to stop the proliferation of the ASF and also the Avian Flu.

Another project that FDA is being entailed is the full digitalization so that the agency will have more application process on time. So we already have talks with the DICT and also the ARTA, the Anti-Red Tape Authority, to have established the one-stop shop. It will help greatly the stakeholders of the drug pharmaceutical industry.

Thank you.

MS. OSEÑA-PAEZ: Okay. Thank you. We can open the floor to questions. Racquel Bayan, Radyo Pilipinas.

RACQUEL BAYAN/RADYO PILIPINAS: Doctor, can we get an update lang po doon sa binabanggit ninyo kanina na ASF vaccine from Vietnam po. Nakapag-issue na po kaya tayo ng certificate of product registration?

FDA DIR. GEN. ZACATE: As to the ASF vaccine from Vietnam, more of the detail can be explained by my director for the Center for Drug and Research.

DIRECTOR CIRUNAY: Good morning, everyone. Hindi pa po, we are waiting for the applications to come in. Thank you.

RACQUEL BAYAN/RADYO PILIPINAS: And then, ma’am, kapag na-submit na po nila iyong application, how soon po kaya tayo makakapag-issue ng CPR?

DIRECTOR CIRUNAY: We do have a timeline with ARTA, it’s a hundred and twenty working days, so it depends on the completeness of their document for us to issue a positive approval. Thank you.

MARICEL HALILI/TV5: Hi, ma’am. Good morning, just a follow-up on Racquel’s question. But what’s your target? How soon can we have the Avian Flu vaccine?

FDA DIR. GEN. ZACATE: Basically, the Avian Flu vaccine, I already launched the Task Force Alectryon. It is composed of different experts. It will focus on the—are we talking about the ASF or Avian Flu?

MARICEL HALILI/TV5: MARICEL HALILI/TV5: Avian and ASF.

FDA DIR. GEN. ZACATE: Avian. I already established two task forces for that. Number one for the ASF, I have established the Task Force Moccus; and for the Avian Flu, I established the Task Force Alectryon. So, those two are composed of different experts that will solely focus on the matter with regard to the ASF (African Swine Flu) and Avian Flu. So we cannot act if there is no applicant. So for the ASF, we have the applicant as of this date, but I think the Avian Flu we have three? Please confirm it.

DIRECTOR CIRUNAY: Thank you very much, DG. We are waiting for them to fully submit the documents that will lead to a registration application. But there are three possible candidates that we know of. Thank you.

MARICEL HALILI/TV5: So can we say that we can have both Avian Flu and African Swine Flu vaccines probably before midyear, mid-this year?

DIRECTOR CIRUNAY: They have to apply first.

Q: Bakit hindi sila nag-a-apply?

FDA DIR. GEN. ZACATE: Well, it depends on them actually. We cannot act if there’s no applicant. We wait for the application. And then if there’s an applicant, we process them. So FDA cannot act if there is no applicant.

KATRINA DOMINGO/ABS-CBN NEWS: Sir/ma’am, can we get some details with regard to the three possible applicants? Which countries are they from? What kinds of pharmaceutical companies are they actually connected with?

DIRECTOR CIRUNAY: Thank you. We cannot give them as of now until they will really lodge the application. Thank you.

Q: [OFF MIC]

DIRECTOR CIRUNAY: We cannot because if they will not lodge—for us to have the details, they have to lodge the application. For now, it is still a speculation. But we know that there could be three, but unfortunately, we cannot give you the details of these possible three applicants.

FDA DIR. GEN. ZACATE: Those three, just according to the intel, iyon iyong paggo-Google-Google namin. So basically, ano lang namin po iyon, kumbaga kung ano iyong possible candidate. Pero we cannot act kapag hindi sila talaga nag-apply.

Q: [OFF MIC]

FDA DIR. GEN. ZACATE: Well, application talaga sila. So basically, that’s more on intel side. Yeah, kasi siyempre po naghahanap-hanap din po kami ng possible kasi proactive means namin sa FDA kasi gusto naming tulungan ang bayan. Pero at least hindi pa kami makapag-act if they will not apply.

MARIZ UMALI/GMA7: Good morning. Sir, just a clarification. So it is just based on your intel, meaning they have not expressed their intent to actually apply for registration for those vaccines?

FDA DIR. CIRUNAY: For us to give you the details, they have to lodge the application. So, if they do not lodge the application and for it to be part of the registration, we cannot say that we are in process of such an application.

MARIZ UMALI/GMA 7: So, Sir Zacate, the one you mentioned that there are possible three, it is just based on your intel? You are just searching for possible vaccines.

DIR. GEN. DR. ZACATE: Yes, because we have also connections with different FDA in the ano…so, some of them, I think they register in some countries but in the Philippines, they must apply to us also.

MARIZ UMALI/GMA 7: If there is no possibility that we ask from them because there’s a need for us to get those vaccines for the Avian Flu situation and the ASF situation in our country, so we really need to wait for them and we cannot tap them and ask for the vaccines for them to actually register?

FDA DIR. CIRUNAY: We release a media announcement encouraging all possible importers to apply for these veterinary vaccines. So, we have been encouraging them and DG Zacate have already mentioned that we establish a TF for us to be ready once they will apply for a registration.

DIR. GEN. DR. ZACATE: To clarify, we cannot proactively tell them to apply into our country because we have a zero contact policy – so, we are regulators. So, what we can do is to ask some regulators outside the country – the foreign FDAs kung ano po iyong mga status ng mga application sa kanila so that if they tend to apply, at least alam na namin na may possibilities sila pero ibig sabihin po we cannot tell them the company “Go ahead, apply here,” because it will be a conflict of interest for the FDA.

MARIZ UMALI/GMA 7: But when you mentioned a while ago that you have been in coordination with the Department of Agriculture – can Department of Agriculture actually ask them to apply, to register?

DIR. GEN. DR. ZACATE: I cannot speak in behalf of the DA but I can tell…

MARIZ UMALI/GMA 7: No, I mean, did you ask DA a while ago when you had coordination with them?

DIR. GEN. DR. ZACATE: With regards to the talks with the DA, we will have a formal talk next week for the JAO (Joint Administrative Order). So, as of now I cannot speak in behalf of them, I can speak only in behalf of the FDA.

MARIZ UMALI/GMA 7: Sir, last. So in other words, wala kahit isa for Avian Flu and ASF, wala pa?

FDA DIR. CIRUNAY: Thank you. Sa current database namin wala kaming currently ini-evaluate na Avian Flu or the ASF, that’s why we are encouraging kasi wala kaming ini-evaluate sa ngayon at this point in time.

MARIZ UMALI/GMA 7: Sorry. What is the difference between encouraging and asking them to apply when you mentioned there is no contact policy that you are actually implementing.

DIR. GEN. DR. ZACATE: The FDA can have a program so that we can encourage “Okay, mayroon naman palang ginawa ang task force ng FDA, mukhang naka-focus sila dito.” So, we can encourage the stakeholder to apply, but we cannot tell them “Apply kayo rito directly.” So, it’s a proactive means for the FDA that we are addressing the problem of the country by forming this task force. This task force will concentrate because it is a pressing matter for the country. But we cannot tell them “Apply, then we will help you,” we’re just telling that we are focusing on the pressing matter issue of the country and it’s up to them to apply.

MS. OSEÑA-PAEZ: Again, this has been identified by the president as an important matter that needs to be addressed because it may affect our agriculture, our protein supply – that’s nutrition for all Filipinos. So, if that helps that it came from the president maybe it’s an encouragement for others to apply here for the African Swine Flu and the Avian Flu.

Go ahead, Eden.

EDEN SANTOS/NET 25: Sir, regarding po doon sa pagpapahaba noong validity noong renewal and iyong permit po ba sa mga manufacturers – kailan po natin ini-expect na magkakaroon ng epekto ito sa presyo ng mga gamot sa ating bansa, iyong talagang mapapababa po?

DIR. GEN. DR. ZACATE: Okay. Number one, i-clarify ko, the lengthening of the CPRs (Certificate of Product Registration) and the LTO (License To Operate) not only in the drug ha but also in the food and also the device, hindi kasi namin puwedeng gawin sa cosmetics kasi maraming variations iyong ating mga stakeholders. But yeah, basically it will help a lot because they will have an assurance that their product will be there for five years to 10 years na subject only for the post-marketing surveillance because the FDA cannot deviate upon the mandate of protecting or safeguarding the health of our country.

EDEN SANTOS/NET 25: So, kailan po natin po ini-expect na magkakaroon ng epekto sa presyo po ng mga gamot at pagkain?

DIR. GEN. DR. ZACATE: As of now the two policies – the administrative order for the unified licensing and the revision of fee for increasing the CPR validity will be transmitted to the Department of Health because it is not administrative order. So, after transmitting to the Department of Health it will be signed by the secretary, it will go back to us and we will have an implementing rules and regulation to that. So, basically a matter of six months it will have.

EDEN SANTOS/NET 25: Additional question lang po, about drugs pa rin naman po ito ‘no. Can you enlighten us about the fentanyl, mayroon ba kayong ano dito?

DIR. GEN. DR. ZACATE: Regarding fentanyl, I think, Director Joyce, if there’s an application or the registration?

FDA DIR. CIRUNAY: Fentanyl is a registered product but for the details I cannot give. We have to give to—you can email to FDA to the details or you can check the verification portal of FDA for fentanyl products registered with FDA.

DIR. GEN. DR. ZACATE: Basically, the answer is yes it has registration but depending on the mode of application – the batch?

FDA DIR. CIRUNAY: Yes. I’m not very familiar with all the products registered with FDA so I would propose to go to the verification portal to get the products that are registered under the generic name fentanyl.

MS. OSEÑA-PAEZ: Okay. Harley Valbuena.

HARLEY VALBUENA/DZME: Good morning po. Sir, ma’am, balik lang ako doon sa vaccines. How about from our local manufacturers and scientists, do we believe that they have the capability to develop the potential vaccines against ASF and Avian Flu? And are we even keen on offering reward or a reward system for any local scientist or manufacturer that can develop the vaccine?

FDA DIR. CIRUNAY: Thank you. We are not aware of a drug development for veterinary products currently done in the Philippines. For the reward it is not within the ambit of FDA.

MS. OSEÑA-PAEZ: Okay. Jean Mangaluz.

JEAN MANGALUZ/INQUIRER.NET: Hi po. Can you please explain what happened since for long na walang ASF and Avian Flu vaccines sa bansa, what are the possible dangers or consequences?

DIR. GEN. DR. ZACATE: Well, basically it has been happening even before the administration, the current administration, of course the food security, iyong meat possibility, the problem with our stakeholders. So, basically, I can only speak in behalf of the FDA that we are doing something so that the vaccine will come in the country. But on other matters, I think there are other departments that can answer your question.

JEAN MANGALUZ/INQUIRER.NET: Sir, follow up, kung sinong agency dapat iyong nag-i-invite directly sa mga manufacturers?

MS. OSEÑA-PAEZ: There’s no official invitational processes but a lot of these things get discussed during foreign trips, bilateral talks, minister-to-minister meetings. So, yeah that’s all I could say for now. Also, you’re asking about the possible impact of Avian Flu and ASF in a little while after this briefing we will have the Department if Agriculture on El Niño, but you can ask that later. Okay?

KATRINA DOMINGO/ABS-CBN.COM: Thank you, ma’am. Sir, a while ago you mentioned that the president has ordered you to speed up the process of approving new generic drugs to further streamline the drug application process. How many requirements used to be ask from these applicants and how many requirements na lang po iyong needed for you to speed up that process.

DIR. GEN. DR. ZACATE: I’m glad that you ask that question because we are already doing the speeding up the process. As of now we are in the verge—me, I’m on the verge of signing the memorandum circular for the facilitation of FRP for generic drug – it means it will shorten the 120 days to 45 days.

So, it is a matter of time that I will sign that. So, mas mapapadali iyong proseso, mas mapapabilis at maikli na lang po ang oras because the DFA has two types of regulations, number one is the full review and number two is the recognition and reliance.

The generic drug, as long as they have been leveled as generic ay wala na silang patent issue at approved naman po sila and it has been in the market of their originating country and then iyong originating country naman niya is strict regulatory agency, pagpasok po noon sa bansa, in-import po natin sa bansa ‘no, it will be subject only to 45 days.

KATRINA DOMINGO/ABS-CBM.COM: Sir, follow up question. Sir, take for example according to ARTA, the applications for let’s say Telcos, with the downed number of documents required from 13 to 8/from 86 to 35 do you have that kind of figure with regard to the approval with the DFA?

FDA DIR. GEN. DR. ZACATE: With regard to the generic drug only?

KATRINA DOMINGO/ ABS-CBM.COM: Yes, sir.

FDA DIR. GEN. DR. ZACATE: I think, Director Joyce will answer your question.

FDA DIR. CIRUNAY: We do not reduce the number of requirements, but we use reliance, example is that, if it came from, say the US FDA or PMDA, titingnan natin iyong ini-evaluate nila, iyong mismong papel na ginamit nila, iyon ang titingnan natin. Kapag it has satisfactorily complied with the requirements of the ASEAN common technical documents, hindi na namin uulitin kasi magre-rely kami sa isang stringent regulatory authority.

Walang ni-reduce na requirements because the safety, efficacy and quality requirement is fixed – it’s in the ASEAN common technical document, ASEAN common technical requirements. Titingnan namin iyong ginamit ni Japan, example, paano nila in-evaluate, if it has already satisfactorily complied, then we will use reliance in approving that particular application just like the US FDA, but we have to see the evaluation of the stringent regulatory authority.

OSEÑA-PAEZ: Tuesday Niu, DZBB

TUESDAY NIU/ DZBB: Hi, Sir. Hi, Ma’am. Ma’am, if I remember it right, October last year, sinabi po ni Presidente na sinisimulan na ng pamahalaan iyong pagbili ng Avian Flu Vaccine. Hindi ko lang [alam] kung FDA o DA ang dapat sumagot, sir, pero whatever happened to that plan po?

FDA DIR. GEN. DR. ZACATE: I don’t think that Avian [Flu Vaccine] iyon. We cannot procure, we are only regulators. We give certificate of product registration. So, regarding po if we are talking about procurement, it’s not FDA. Basically, bawal po sa amin iyon.

TUESDAY NIU/ DZBB: Okay, another thing, sir. Itong Pharma-zone, papaano po ang magiging set up at saan po ilalagay na parte ng bansa itong Pharma-zone na ito?

FDA DIR. GEN. DR. ZACATE: Basically, there is one ‘no. According to the sectoral meeting, napakaganda po ng proyekto ng ating presidente kasi kung tatlo po iyan ‘no, we will have more influx of essential and generic drug. As of now, there are three main, but iyong isa is I think the new Clark; but the two has yet to be determined by the PEZA itself kasi hindi pupuwedeng makapag-determine iyong FDA. We’re just there to streamline the process.

OSEÑA-PAEZ: Christine Maralit, Manila Times.

KRISTINA MARALIT /THE MANILA TIMES: Hi, ma’am. Hi, sir. On a separate issue po, recently po ang daming nag-proliferate na mga products online and ang mga ginagamit pong endorser o iyong tagabenta influencer ay celebrities and iba’t ibang claims po iyong ginagawa, pero hindi po tinitingnan ang mga nagrireklamo regarding their negative side effects, even though they claimed to be FDA-approved and registered. Ano pong hakbang ang ginagawa ng FDA dito, may mga ahensiya po ba tayong nakakatulong to address this issue?

FDA DIR. GEN. DR. ZACATE: Basically, the approval of the FDA, iyon lang po ang safe, efficient and quality. So, for example if a product has been approved for a certain indication, doon lang po makakagarantiya iyong ating mga mamamayan na ito po ay nagdaan sa proseso ng FDA, particularly in drug.

Regarding sa fake advertisement, we have been coordinating with the National Bureau of Investigation and with some celebrities, I don’t want to metion them, but we have been coordinating with them since last year.

So, ang problem lang po kasi dito sa mga online, ulitin ko po, since the last interview, when they post they can always take down the post. So, if we seize the product, if we get a subpoena or summon for those fake advertises, we need a certain location, kinakailangan naming ma-serve iyong notice sa kanila. And ang problema doon karamihan po diyan ay mga wala naman pong opisina, kasi nga po peke eh ‘di ba?

So, nahihirapan po kami kaya namin tinap (tapped) ang National Bureau of Investigation to locate those people, pero sabi nga po namin mas malansa pa po sa isda iyan – kapag nakita nilang ini-interrogate sila or ini-investigate sila, they just take down the post, then they will move and they will create another account. So iyan, we are finding it very difficult, but for this year we will have a task force, a conglomerate of different enforcement agencies.

Last year I launched Oplan Katharos, that’s for the counterfeit medicine. So, this one I think it’s very problematic ‘no, fake advertisement. So, I will launch a task force together with number one, the NBI, the PNP-CIDG, the NICA and the patent office, the IPO, so that we will have a one unitary enforcement agency. So, maybe soon, maybe later this year.

OSEÑA-PAEZ: Thank you, Allan Francisco, PTV 4.

ALLAN FRANCISCO /PTV4: Hi po. Sir, for so long there has been a comparison between a branded and generic medicines, kumusta na, sir, ngayon ang pananaw o pagtanggap ng mga Pilipino sa generics?

FDA DIR. GEN. DR. ZACATE: Basically, when we talk about the branded and the generic, when we say generic, it’s the generic name of the drug ‘no. Sa generic, for example one drug babaguhin iyong brand, but iyan po ay nagdaan lahat sa proseso ng FDA. We call it—we test the bioavailability of the drug, when it passed the FDA pantay-pantay po lahat iyan. So, basically wala pong tinatawag na “generic lang iyan, branded iyan” pantay-pantay po lahat iyan. Basta po nagdaan sa masusing proseso at testing ng Food and Drug Administration, makakagarantiya po ang taumbayan na ang gamot ay ligtas, mabisa at makakagamot ng inyong mga sakit.

OSEÑA-PAEZ: Maricel Halili, TV5.

MARICEL HALILI / TV5: Sir, on other issue, about marijuana. Usap-usapan kasi iyong legalization of medical cannabis, but then some medical associations under PMA are against the legalization of this and legislation of medical marijuana. May we know your take on this, sir?

FDA DIR. GEN. DR. ZACATE: Basically, the law on marijuana is subject to the wisdom of the legislative, at hindi ko kaya silang pangunahan kasi sila po ang number one na magpapasa ng batas. But my take is medicine is an innovation, we cannot guarantee na ito lang po tayo at darating sa future eh wala na, hanggang dito na lang. Let’s take for example penicillin. It came [out for] fungi, and now ang dami na pong nagagamot na sugat at mga antibiotics na nga po siya.

So my take on marijuana is that I am open, ibig sabihin, the Filipinos must have a wide range of therapeutic indication or therapeutic drug of choice. So, ako po ay…opo, for the record, the Food and Drug Administration, and me as director general, is very much open for the marijuana as long that it has been streamlined ‘no, at hindi naman po makakasama po sa taumbayan.

OSEÑA-PAEZ: Okay last few questions. Jean Mangaluz again, Inquirer.net

JEAN MANGALUZ / INQUIRER.NET: Hi, po. Can you please give us an update on how the COVID-19 drugs, not vaccine, have been approved by the FDA and is it now open to the Philippine market?

FDA DIR. CIRUNAY: Thank you. Yes, approval process is the same with the rest. Initially these were emergency use authorization (EUA). And then, there was a creation of a task force, the task force both for medicine and vaccines for the conversion of the EUA products, medicines and vaccines to normal CPR. So, there are already COVID-19 medicines available in the Philippines and also, we are encouraging because it’s continuously developing with the variants available for the manufacturers and their importers here to also apply the other variants, the other vaccines through the product registration process of the Food and Drugs Administration.

FDA DIR. GEN. DR. ZACATE: In addition to that, the EUA that was previously issued by the FDA relied mostly on the public health emergency. So, since it was lifted, the EUA, the Emergency Use Authorization, has no effect already. So that’s why, as a proactive means, again, I launched many task force ‘no – task force for the COVID drug – so that the applicants, the stakeholder will get the image that ‘oh the FDA is doing something,’ because it is a pressing matter, COVID is a pandemic so, iyon po.

As of now, wala pa po tayong na-approve, but my people are currently focusing on that matter.

MS. OSEÑA-PAEZ: Okay, I think we’re done with the questions. Thank you so much Director General Zacate and Director Cirunay of the FDA and maraming salamat Malacañang Press Corps and we will see you a little while for our next briefing. Thank you.

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