Wednesday, May 06, 2009

FDA Watch 1: BFAD Strengthening Bill

A proposed law strengthening the Bureau of Food and Drugs (BFAD) under the Department of Health (DOH) is now in the bicameral committee of the Philippine Senate and the House of Representatives. It's called the Food and Drugs Administration (FDA) bill.

I did not know that less than a year after the enactment of "Cheaper medicines law" or RA 9502 where a chapter for BFAD strengthening was included, another law will soon be enacted on BFAD alone.

A friend informed me that this BFAD bill has been there for several years. But since the IPR and patent aspect of pharmaceutical products was the "hot" issue then, it was pursued and the BFAD strengthening was included as a "rider" chapter in the law. Not bad because it is now a law with implementing rules and regulations (IRR).

My main observation of the proposed new law is that the important "ingredients" to strengthen BFAD are already in RA 9502 -- retention of income, continue receiving annual appropriations for at least 5 years, freedom to review and hike fees and charges. If money is the problem for BFAD, then the current law already provides it with enough flexibilities. So, I am wondering why pursue this new, separate bill and nearing enactment into a law.

If one goal is to further strengthen post-marketing, post-sale monitoring of pharmaceutical products, then that "order" is already in RA 9502 and its IRR. Besides, BFAD only has to worry or keep watch of those cheap and parallel imported medicines from lesser-known pharmaceutical companies. The bigger pharma companies have strict pharmaco-vigilance corporate practices imposed upon them by (a) their own shareholders and stockowners, and (b) industry associations, both national and international, where they belong.

My daughter's pediatrician for instance, told us once that she sticks to the products of one or two pharma companies because of a single criteria: medicine quality and strict pharmaco-vigilance. Just a single incident of negative effect to patients, if confirmed, immediately results in product recall, recall the medicines and other health products before the public and media will report any negative side effect to patients. So all the products they sell are only of good quality medicines, no counterfeit, no substandard, no mis-stored or mis-handled products.

She added that there are plenty of medical representatives from other pharma companies, usually from India, approaching her to endorse their product. She asks them if they have BFAD clearance, any pharmaco-vigilance procedures, these guys cannot produce any. They simply want to sell cheap and affordable medicines, with possibly questionable quality, that can possibly worsen the situation of patients.

I also notice in the bicam bill, that the proposed FDA is creating new offices or divisions within it. And perhaps expanding existing ones. If BFAD wants to expand itself into a huge bureaucracy, I think there is nothing in the current law that prevents it from doing it. They got plenty of money, with continuing appropriation from Congress + retention of income, it is possible for BFAD to perpetuate its own bureaucracy. All they have to do is to justify and explain their move to the Congressional Oversight Committee every year. If Congress will not object to the expansion of the BFAD bureaucracy, then they can continue the expansion. No need to create a new law for that.

It seems a lousy bill. BFAD could have waited for a few years and work with the current provisions given by RA 9502 on BFAD strengthening.

However, since that bill will soon become a law as it is now in the bicameral committee, the provisions on drug assessment for locally manufactured and parallel imported drugs should be strong. Patients can easily be hoodwinked into buying any cheap medicine, without knowing that they are taking fake or sub-standard medicines that will not help them get cured, or will even allow the virus in their body to mutate as they stay longer, resulting in even prolonged treatment period, if not produce another diseases in the body.

With the current proliferation of counterfeit medicines, sub-standard medicines, which I feel will be amplified under the parallel importation scheme, then BFAD should indeed be strengthened. I find the parallel importation scheme lousy. The drug manufacturer abroad, the wholesaler, importer, retailer at home, are different entities. When a drug is defective, say can cause negative side effects and bad allergies to the patient, or it lacked its effectivity due to wrong handling, wrong storage, wrong temperature control, etc, who will be accountable? The foreign manufacturer, or the importer, or the drug store, or the local patent holder (but did not sell those drugs), or the physician, or BFAD, or DOH, or the legislators?

But that provision is already in the law, RA 9502, it's now implemented. BFAD or the proposed FDA should therefore monitor those parallel imported drugs, especially from India where the WHO itself says is the origin of about half (or 70%?) of all counterfeit medicines in the world.

Meanwhile, I wrote this last February 11, 2009.

Biomedical research does not need fiscal stimulus

There’s an article from the other day forwarded by a friend, entitled “Biomedical research is ripe for a stimulus” written by Garret FitzGerald. The author is the Director of the Institute for Translational Medicine and Therapeutics at the University of Pennsylvania, and serves on the Peer Review Advisory Committee of the NIH and the Science Board of the FDA.

In his paper, Mr. FitzGerald is clapping the injection of taxpayers’ money, aka fiscal stimulus, to the biomedical research sector through the following mechanisms, among others:

1. Restore funding for the National Institutes of Health (NIH). The new director must have resources to fuel innovation by individual investigators and invest in infrastructure.

2. Integrate the disparate missions of the NIH and the Department of Health and Human Services -- particularly its Agency for Healthcare Research and Quality and the Food and Drug Administration (FDA).

3. Reward innovation and foster the progressive personalization of medicine. Fund programs that foster interaction of the FDA with academia.

This is one of many statist literatures that circulate in praise of more fiscal stimulus, more government borrowings and subsidies, and indirectly, more taxation in the future. Expansion of NIH, government – not the consumers and the public – rewarding innovation, more funds for FDA and the academe.

I thought it’s the consumers and patients, the physicians and other health professionals, who determine who among the many pharmaceutical and biotechnology companies, are the most innovative, the ones who produced the most effective and most useful medicines and other health products. Now it is the government officials who will determine who and what are the most innovative companies and products.

People value their health a lot. That is why many of them are very careful with their body, while a few are very irresponsible with their body and yet very vocal in demanding that quality health care is their “basic right”. For the responsible people, they would wish that personal income and other taxes are lower so that they can save more, and they can invest more for their personal and family healthcare. And for the responsible and innovator companies, they also wish that corporate income and other taxes are lower so they can have more corporate surplus to pump into more biomedical research and development, and to reward their investors and shareholders who put their money in biomedical and pharmaceutical companies, and not in other industries or sector.

In short, the biomedical sector does not need fiscal stimulus and other forms of government subsidies, if the distortions to personal and corporate endeavors invented by governments are few or absent.

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