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May 29, 2008

Where is FDA in the presidential discussion?

Maybe I have a bit of tunnel vision, but has anyone else been waiting for the candidates of both parties to start paying more attention to the FDA? Clearly, healthcare has been a central issue of debate. Understandably, the candidates have focused on providing better and cheaper healthcare coverage to their potential constituents. At this point, as candidates McCain, Clinton and Obama are pressed more than ever to articulate their vision for the nation, or in this instance, the nation's health, it seems only logical that they discuss how they would solve the myriad of problems at the gigantic central government agency pivotal to this proffered health.

According to a recent statistic, the FDA regulates 25 cents of every dollar spent in the United States. Over the last two decades, Congress has broadened the FDA's reach and responsibility 127 times, and, oh-so-unfortunate but typically, have not put their money where their legislation goes. Most recently, another headline emerged from China—the land everyone loves to hear connected to a scandal concerning harmful chemicals—with the Baxter/Heparin debacle. Personally, I think Baxter could see sales fall for a tangential reason: the fact that so many people now know heparin comes from pig intestines. This latest event makes the seemingly outlandish idea of establishing an FDA office in China and other countries overseas to monitor imports seem less and less ridiculous. But it also shows how out of touch the FDA's role is with the modern, globalized world.

Though a failure sure to be tied to the FDA, this latest event really indicates that the FDA passed "over-extended" about 28 extensions ago. Washington has finally come to this realization in response to a series of investigations - apparently all the crises weren't enough to solidify the fact. Luckily, the investigations do note that the FDA's lack of capability does not stem solely from a paucity of funds, but also from the need to make major reforms to the bureaucracy's structure, testing and priorities. The study distressingly found that the FDA cannot keep up with the advances of modern science and many of the regulation, statistical requirements and study guidelines by which the FDA plays no longer apply. Moreover, the FDA often does not have the correct staff to appropriately understand, evaluate and approve drugs in new, complex fields.

While depressing to hear, to me this seems to be a more acceptable reason for the low number of new drugs approved this year as opposed to the FDA being unnecessarily stringent in the face of public outcry and political pressure. Being scientifically out-of-date is far better than pandering at the expense of science. It also seems to be a more tractable problem with a more direct solution. Yet, the two problems could also be coalescing. Applying archaic standards to modern science and not having the capacity to change it, while also being pressured to step up the monitoring and safety, seems quite the recipe for squeezed bureaucrats to start worrying more about performance reviews and less about scientific advancement.

Yet, solutions will only be found if the problems are acknowledged and we all know how accustomed those on Capitol Hill are to the elephant in the living room. There has been much more discussion about the fact that the proposed increase in the budget is far too little for all the demands of the FDA, and none about the fact that FDA may have too much on its plate. Nor has there been any serious discussion about reforming the agency to reflect today's market, rather than that of the 50s when the policies were instituted. It's so much easier to conspicuously throw money at a problem rather than solve it.

I guess this is why I keep waiting for the people vying for the top job in the land to address the issue. All three of the candidates left standing have talked about reform and fixing a broken Washington. Neither dedicating more funds to the FDA, nor cutting government programs, nor raising taxes, nor lowering taxes, nor bi-partisanship in and of itself will solve this problem. It will take true reform. This side of healthcare should be discussed and potential solutions offered as part of a larger overhaul of American healthcare. But I am guessing the FDA will just have to take a ticket and get in line.

Posted by Jordan Stone at 09:30 AM | Comments (0)

May 13, 2008

Ins and Outs of the Healthcare Issue

Fortune interviewed Aetna CEO Ron Williams about the state of health care insurance in America. I found the stats in the quote below fascinating:

"I'm always amazed that 20% of the 47 million uninsured are eligible today for Medicaid or the Children's Health Insurance Program. They could sign up and have a relationship with a primary-care physician. About 10% of the 47 million are college and university students, very inexpensive to insure. Slightly more than 20% are not citizens but are in the country legally.

"We might find a way to link visa entry or other mechanisms with comprehensive coverage. And about 20% have household incomes above $75,000. On this we agree with many of the presidential candidates. Aetna believes there is a place for an individual coverage requirement for individuals who can afford insurance. I think reasonable people could agree that at some point there's enough income that someone should be expected to participate in the health-care system. That leaves us with about 14 million to 17 million who really need tax credits and subsidies or tax deductions."

We'll take his stats at face value for the moment, and halfway discount the Aetna commercial for government-required coverage of people earning $75,000 or more.

I'm left with three thoughts:

#1, significant parts of the uninsured issue parallel the patient compliance issue. Blaming the uninsured is a not the solution, but a good portion of those who are uninsured are either unaware that they don't have to go without insurance or unwilling to pay a manageable amount for it.

#2, the number of people who fall fully outside the system with no present way to get health care is more manageable than many people think.

#3, as a small business owner, I can tell you that many of the real problems of American health insurance are to be found in the costs for the fully insured.

Posted by Jason Richardson at 12:27 PM | Comments (0)