Wednesday, May 16, 2012

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,
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.

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

1 comment:

Kid at heart said...

Suzette did not resign. She reached the mandatory age of retirement at 65 for service in the government. She applied for an extension but it was denied. After all, there are also competent and qualified people to finish what she started. I hope this clears up the air and that there isn't much drama over Suzette's resignation.