FDA Watch 3: Retirement of Dr. Suzette Lazo from FDA

(* Note: the original title of this paper was "Resignation of Dr. Suzette...")

I posted my initial observation about the Senate hearing last week on DPRB,  Fat-Free Econ 9: Drug Pricing Bureaucracy is Not Cool in our CHAT googlegroups. FDA Director, Dr. Suzette Lazo, is a member of our discussion group as she used to be with us before she was appointed to head that office.

In my notes to the group, I said that some of our legislators motormouth like they know everything in this planet, they are hypocrites. I pity Doc Suzette and other guest speakers sometimes because while they have to do many administrative work in their offices, attend to various invites and meetings by sectors that they  regulate, they have to spend many hours at the Senate or Congress, only to speak for 3 minutes or less.

Sen. Villar and the congressmen, they have been in the legislative body for many years (Villar has been in Congress since the 90s), and they do not understand that FDA's mandate is on food and drugs' quality, never on pricing. Yet they keep inviting the FDA officials to discuss bills on drug pricing, weird.

Doc Suzette replied to my observation, rather long. I thank her for giving me permission to post it in this blog. She wrote,

Noy,

This very perceptive insight on your part is totally correct and I really appreciate. In fact very few in government understand what the FDA is all about- although they act like they do. I have been giving presentations on this when I get the chance- para akong evangelist ng FDA. It is a poorly understood agency, much maligned and very little appreciated. People don't realize that it is the only government agency that stands between them and safety - as it looks after a very wide array of products: food, drugs (including biological vaccines and veterinary drugs), cosmetics and all personal care products, household hazardous substances (detergents, antiseptics, etc), household pesticides, medical devices including radiation-emitting devices, medical gases, in vitro reagents, bottled water, toys, some school supplies (pencils, crayons, inks), even tobacco but voided by an RTC court (no regulation to thwart the recruitment of the young to become hooked to tobacco).

I also want to share with the MeTA family that my position as head of the agency will be coming to a close next month. It has been a life-changing experience for me and an honor to serve government. I hope the many reforms I have started will be continued. This includes requiring mandatory GMP , inspection of foreign drug sources, evaluation of the drug approval process with the help of WHO who will be conducting an assessment on JUne 18th this year. The FDA is now undergoing ISO-certification hopefully to be completed within the year and it will also undergo PIC/s audit on September. A new Bioequivalence Committee is now in place and reviewing the list of products that will require bioequivalence testing; a new Advisory Committee on Pesticide is being set-up to address the critical safety issues and strengthen FDA's regulatory capability in this area; pesticides was placed under FDA jurisdiction in 2007 from the Fertilizer and Pesticide Authority. It was a great privilege to work with other agencies in governments such as the Dept of Agriculture to craft a much needed Food Safety Bill that will hopefully be passed soon. Linkages with other agencies were also a source of support.There were other great linkages such as with advocacy groups like ECOWASTE whose goals paralleld FDA's in line with ensuring safe cosmetics and toys; all the groups under CHAT also supported me at all levels from the budget to the most personal level and I will forever be grateful. And more - Health Justice for their support in the issues FDA faced with tobacco groups. With the academe, notably PCP and PSECP, as well as other specialty medical organizations there were multifold projects and support- such as ensuring the usefulness of the last medicines effective against MDR-TB. The Phil. Society of Dermatology helped FDA's campaign against the irrational use of intravenous glutathione. With DOST=PCHRD, and the ethics board, PHREB, a new framework and road map for clinical research management seeks to create a streamlined environment for global clinical research that will ensure the protection of Filipino patients participating in clinical trials and make available a robust regulatory environment that that promote and not impede progress. It has also been my honor and burden to play a major role in the implementation of RA 9711 which is now in the hopefully, final stages of review by DBM.

It has also become very apparent that there is a lot of work that needs to be done. First, the country needs an institution geared at training people in regulatory affairs. Second, there is a need to bridge science, real science, into the government decision making process. Countless sessions to clarify many issues should precede legislative hearings. Third, our innumerable laws need to be reviewed and harmonized. For the clinical research project, there is a collaborative effort between government, academe and industry that seeks to come up an integration of all the documents, to see if the laws jive or contravene one another, to cross-reference, etc and to distill the entire substance into a clear summary.

I have known Doc Suzette for about 3 1/2 years now, since January 2009. And I can say that being incompetent or corrupt is the last thing that can describe her. She is simply a down to earth pharmacology scientist and academic who was appointed to head a big regulatory body like the FDA.

Now that is leaving the FDA, not due to health reason perhaps, my rather malicious mind would like to think that there could be something rotten in that agency, but I doubt that she will discuss it publicly.

FDA, like all regulatory agencies in the government, national and local, can be a good magnet for scumbugs and bad elements in society. Why? Because those agencies can say Yes or No to anyone trying to bring in or introduce new products and services -- a new drug, a new skin whitener or shampoo, a new toothpaste or deodorant, a new sauce or pasta, a new juice or energy drink, etc.

Corrupt or shrewd businessmen with connection to powerful politicians though, can bring in the most unsafe drugs, the most unsafe food and drinks, to the country and avoid any requirement for bioequivalence test, or food safety test, by paying off some regulators. Likewise, businessmen who want to bring in really safe drugs, food and drinks cannot sell their products if certain regulators and product inspectors will demand extortion money.

I am not saying that certain FDA people are corrupt, that's too malicious and would require substantial proof which I do not posses. But theoretically, it is a possibility, given the high level of corruption in the Philippine government, in all branches. That is why I can never support any expansion of government, like creating a new bureaucracy called the Drug Price Regulatory Board (DPRB) because it will invite another opportunity for corruption. If the government and all its anti-corruption bodies -- Commission on Audit (COA), Ombudsman, Civil Service Commission (CSC), Presidential AntI-Graft Commission (PAGC), etc. -- cannot control existing corruption, how can they control future corruption with future bureaucracies to be created?

That is why we in civil society like the member-NGOs of CHAT, should never be hoodwinked that government is the solution to many problems in society. A lot of the problems in society in fact, are created by governments. Like the poor who do not want to be dependent on politicians, they put up a barbecue stand, a barber shop, vulcanizing shop, buko kariton, etc., and yet the local governments think these are illegal because they need to get various permits from city hall before they start their business. That's how buko kariton are being confiscated here in Makati by city hall trucks, the penalty is P1,000 no receipt possibly, they release the kariton, then go and confiscate them again the next few months. Money that could have been used by the poor vendors for their family is given to city hall or BIR bureaucrats. But I digress.

In order to make the job of the FDA and other government regulatory agencies in charge of ensuring public safety from harmful substances much easier and less bureaucratic, I think we should encourage, or at least not put more bureaucracies, companies and entrepreneurs to develop their own brands. Corporate trademark and brands that simply say, "Our name is our guarantee to the good quality of our products."

Thus, food manufacturer A that sells dozens of different food products need not bring in all their existing products to the FDA for quality testing. The trick is that just one, just one of its dozens or hundreds of different products that is found to be unsafe, will negatively affect the entire company. It will be a corporate brand that was built for many years or decades as having good image, will now be tarnished by just one product that is found to be dirty or harmful. That public penalty is worse than the FDA stopping the sale of one or two of its products into the market.

The same principle should apply to drug manufacturers, innovator or generics; should apply to all juice and drink manufacturers, multinational or local.

I doubt though that this principle will be considered by any government regulatory agency. There is money involved also in each approved product, like product certification fee, something that goes to the coffers of a regulatory body.

Meanwhile, I wish to see Doc Suzette more in CHAT and MeTA Philippines meetings and other activities when she goes back as an academic and NGO leader.
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See also:
FDA Watch 1: BFAD Strengthening Bill, May 06, 2009
FDA Watch 2: Inspection of cGMP Compliance, January 31, 2011


Health Transparency 1: MeTA Forum January 2009, January 26, 2009
Health Transparency 2: CHAT Discussion and Debates, June 15, 2009
Health Transparency 3: MeTA Forum January 2010 (Prevention vs. Medication), January 27, 2010
Health Transparency 4: Drug Promotions and Government, September 03, 2010
Health Transparency 5: Forum on Good Governance in Health, March 08, 2012

RUM 3: On Combining Drug Molecules and Alaxan FR

After I posted RUM 2: SARAH, Drug Dependence and announced to several players and leaders in the Philippine health sector, focus shifted about drugs advertising and the molecular combination of paracetamol + ibuprofen of Alaxan FR. So I emailed the other day Dr. Suzette Lazo, a friend and Director of the Food and Drugs Administration (FDA, http://www.fda.gov.ph/) via our CHAT googlegroups, as well as Dr. Nazarita Tacandong, another friend and FDA Deputy Director. I wrote,

Hi Docs Suzette, Nancy,

When Doc Delen de la Paz asked during the DOH Consultative meeting on RUM, "Is it advisable to combine paracetamol + ibuprofen (Alaxan FR) in the first place", I did not ask for her answer but I can see that her implied answer is No.

Doc Isidro Sia also gave the warning of not taking that drug on empty stomach as there is high possibility of adverse health results, suggesting that the combination of those 2 molecules can be tricky.

Another physician friend commented today,

"In response to your question in your blog, it is irrational to combine paracetamol and ibuprofen in my professional opinion. This is an example of fixed dosed combination. But United Lab may have some scientific data to show efficacy, but I have never seen this. I wonder if BFAD then allowed this based on science or based on other reasons."

That's 0-3 score disfavor for Alaxan FR molecular combination. I am no physician nor pharmacist so I have to ask you this question, why FDA allowed such combination given the high use of that drug by the public?

Doc Suzette gave a reply, below. She gave me permission to post her reply in this blog. Meanwhile, here are some of the ads for Alaxan FR, a very popular pain reliever here mainly because of its endorser, Manny Pacquiao.

Noy, this drug has been approved by the FDA since the 80s. The requirement is that for fixed-dosed combinations to be approved they must be compliant on a number of things: show synergy (of efficacy), stability of components in combination, etc. So as this was approved, Alaxan must have complied. Of course, fixed dose combinations get rather contentious sometimes because of differing opinions, which may not hold much water unless supported by evidence. An important issue is if there's a safety problem here? Are (we) seeing cases of drug-related morbidity related to use of the drug? There's no data so far from the people who are criticizing it so where do we go from here?

For your info there are far worse preparations that have been approved and these things sell too. FDA is in the direction of working towards cleaning up the bundle of approved drugs but this wont happen overnight.

Suzette 

IPR and medicines 13: Improving Generics Quality

This is the continuation of my notes on the 2nd Generics Summit held last week at Richmonde Hotel, Eastwood, Quezon City. See earlier note, Part 12: Expanding Generics, September 09, 2011.

Day 2 of the conference, morning panel was on "Higher Levels of Quality". The presenters were Dr. Suzette Lazo, FDA Director, she spoke on the Food and Drugs Strengthening Act (RA 9711). The other speaker was Jesusa Joyce Cirunay, Chief of FDA Regulations Division, who talked on two related topics, (a) ASEAN Harmonization and ASEAN Economic Community by 2015, and (b) Pharmaceutical Product Working Group (PPWG) and Pharmaceutical Inspection Cooperation Scheme (PIC/S).

Ms. Cirunay here, speaking. Now there's another twist in this panel. The civil society reactor for this panel was not prepared to talk, my friend from DOH again asked me if I can replace him. I had second thought because I came late and I did not hear Doc Suzette Lazo's presentation. Later I said Yes. Again, with just 5-10 minutes to prepare, I jot down my thoughts and made these comments as a panel reactor.

I have one comment then one question. On harmonization: companies and consumers benefit from product differentiation, competition and market segmentation, to recognize different consumers with different needs and different budget. When you harmonize, you tend to standardize, go for uniformity, even monotony.

The ASEAN harmonization is partly patterned from EU harmonization. EU harmonization is to a certain extent a regional EU protectionism. When the newly market economies of Eastern Europe (Czech, Latvia, etc.) that joined the EU introduced low income taxes, both corporate and individual income taxes, it created tax competition within the EU as the big EU countries like Germany, France, UK, have high income taxes. Some companies there moved out and went to the low-taxes EU members. The bureaucrats in the high taxes countries were not happy with this, so they introduced tax harmonization. I am not saying that harmonization per se is bad since one goal of harmonization is to have one general standard of regulations, but there are features of harmonization that are not in favor of consumers as it tends to reduce competition and differentiation.

Now to my question: Isn't ASEAN harmonization a form of regional protectionism? Say pharma products from Indonesia, Malaysia, Singapore, etc. can easily go in and out within ASEAN, but pharma products from India, China, Pakistan, etc. which are said to be the sources of cheaper medicines, will have a harder time coming in?

Doc Suzette Lazo replied that it's not their field to answer the question, that perhaps economists like me can better answer that question. Ms. Cirunay replied that if there are trade disputes like protectionism, there is the WTO that country governments can go to file a complaint.

I was satisfied with their brief answers, I did not make a follow up questions anymore. After the panel break and snacks, Doc Suzette called me to her table and kidded me, "Noy, ang hirap naman sagutin ng tanong mo, pang-econ yon eh", to which I laughingly replied, "Kasi Doc, naisip ko lang, baka may ilang vested pharma companies within ASEAN who want to reduce competition from Indian pharma or Chinese pharma."

The next activity was the awarding of certificate of Good Manufacturing Practices (cGMP) to several local pharma companies. This is a good move to encourage better, world-class generics manufacturing standards.

The afternoon session was on "Rational Use of Medicines". The program director of DOH-NCPAM, Dr. Melissa Guerrero, presented the Philippine Medicines Policy 2011-2016. Then four speakers followed her. (a) Dr. Isidro Sia, Chairman of the Formulary Executive Council (FEC) presented the Philippine National Drug Formulary.

(b) Dr. Armando Crisostomo of UP College of Medicine (speaking in this picture) talked about Anti-Microbial Resistance (AMR)-Global Strategies; (c) Ms. Catherine Dauphine of WHO talked about the Regulation of Pharmaceutical Promotion in the Philippines; and (d) Mr. Lyle Morrell of Watsons Pharmacy talked about Industry Initiatives & Compliance to Rational Use of Medicines.

From left: Dr. Sia, Dr. Crisostomo, Ms. Dauphine, Mr. Morrell and Dr. Guerrero.

I liked Dr. Crisostomo's presentation. AMR kills by tens of thousands worldwide as old diseases can easily evolve or mutate into new diseases. He said something like 440,000 new cases of MDR (microbial disease resistance) annually. That's a rather scary number. He mentioned about the need for new drug innovation to battle those mutating diseases. I notice that in his presentation though, he quoted several times WHO Director-General Margaret Chan, that I felt like his paper was partly a WHO presentation.

Mr. Morrell mentioned about the threat of the Superbug -- the antibiotic resistant bacteria -- and the need for patients' compliance of their medication. He has two important advice to patients: (a) Do not self-medicate, and (b) complete your antibiotic prescription. He also shared the frustration of some Watson's pharmacists, that antibiotics are prescription drugs, not over the counter (OTC) drugs. A number of their pharmacists are berated by some customers who insist that they can buy any antibiotics even without prescription from physicians. Tough job, Lyle.

The last activity of the two-days event was the signing by key players and stakeholders of the Philippine Medicines Policy.

Sometimes I could be not-so-kind with the DOH in my past writings especially on the drug price control policy. But the DOH deserves kind words and appreciation for holding such a successful event where the proper roles of drug innovation and generic drugs were highlighted.

Some photos of the Generics Exhibit at the Eastwood Mall, just one floor below the conference venue. The local generics industry is showing constant improvement in both product quality and marketing sophistication.

Nonetheless, the public should realize that without drug innovation, without new molecules discovered by the innovator companies, there will be no generic drugs.

During coffee breaks, the subject of deaths from dengue would crop up from our informal talks. This mosquito-transmitted infectious disease is killing both rich and poor, within days and sometimes, within hours, if not properly diagnosed and controlled. There is one recent case of the child of the country director of one multinational pharma in the Philippines, a teenager who died of dengue.

The bad news is that currently, there is no vaccine yet against dengue worldwide. The good news is that a vaccine would be coming in 2 to 3 years from at least two innovator companies. Some sectors though would insist, "Aha, new vaccine, patented and hence, expensive. Government should issue a compulsory license or exhaustion of rights (ie, parallel importation) policy since that drug responds to a health emergency for many areas in the country."

I say that it is not a good way to treat drug innovation. To treat the inventors of modern and more revolutionary drugs as profit-hungry wolves is not only unfair, but it invites new government intervention based on envy. There is a place under the Sun for both innovator drugs and generic drugs. What is "new" and innovator drugs today will be "old" and generic drugs tomorrow.