Wednesday, January 14, 2009

Regulatory oversight - the Health Sciences Authority & the FDA

I was afraid that my comments about AVA might give the impression that I am somehow picking on them, that I had some bone of contention. Not so. Just so happened they had contemporary issues when I am blogging. From a medical perspective, actually the Health Sciences Authority (HSA) is the agency I should perhaps be picking on.

Actually they have their share of problems. Many of the problems arise from the same weaknesses in the system, not just locally but at a global level as well. I did a quick Google of FDA (US Food and Drug Administration) related news, and wasn't really surprised by what I found. A number of recent reports are worth looking at. Both point to the major conflict of interest problems affecting the FDA.

The Financial Times says it's time for a fresh start to the FDA. It says, "The first action of the new administration should be the swift appointment of a strong, respected, knowledgeable and independent new commissioner. For more than four years, the FDA suffered under bosses not formally confirmed, or who failed to defend it robustly. Its next leader needs to take full responsibility for the agency with maximum political support.That person must investigate allegations of conflicts of interest. Just as important, he or she must ensure clearer future rules. Products that fail to meet regulatory hurdles should be rejected, but the FDA must be clearer with companies in how it makes decisions, and stick to them."

Too often the FDA has been regulating with one eye on the big business interests of big pharma industries. This is something that struck me...the FDA is an enormous animal with major government backing. It is the biggest drug regulator in the world. Yet it is not free of the conflicts of interest problems that you expect might be infecting smaller regulatory agencies. I couldn't help wondering how our HSA deals with this problem. Like other regulatory agencies in Singapore, it has a strong promotional mission. It must support the establishment of the Singapore Medical Hub. It must support the Ministry of Trade and Industry's efforts to bring big Pharma into Singapore. It must support Biomedical Research and Clinical Trials. How I wonder, does it find time to support its mission to protect consumer interests?

The HSA is supposed to regulate clinical trials (read protect trial subjects), yet it is supposed to promote and support the clinical trials initiatives. It is supposed to protect consumers from dangerous drugs and chemicals, yet it is supposed to support and promote the market, not just big western pharma industry, but the traditional medicine herbal market, as well the nutritional supplement market. This is really megabucks stuff. Just imagine the number of phonecalls that get made, if they say no to a major pharma company.

At a governance level, the HSA apparently continues to be a Ministry of Health animal despite being a statutory board. Apparently this kind of relationship is quite common for our stat boards, so although it has a properly constituted Board with fiduciary responsibilities, it principally takes it's cues from the MOH. However, because a lot of its regulatory activities relate to Trade/Industry initiatives, it has to keep an eye on this front. At the very least, it cannot inhibit or stumble trade and economy related initiatives. We can only hope that the HSA can try harder to look beyond these pressures to its core role to protect the consumer public. But that may be expecting too much.

So the cynical person I am, I expect the s*** to hit the fan on a regular basis.

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