Thank God for the Government

Those of you who know me well, or if you’ve read some of the posts here, know that I’m fairly conservative politically. I’ve also tried to keep this column apolitical, although I don’t suppose that such a thing is ever really possible. So you may be surprised by the title of this entry. While I’m not a fan of big government, or of government intervention, I do support a fair balance between individual liberty and reasonable oversight. Big Brother has given us some essential protections that, while one may argue around the edges, we are all far better off having than being without.

Government agencies are not in the most enviable of positions. When things are going well, everyone wants to make cuts, because clearly, they have done their job and why should we continue paying for bloated infrastructure? When problems happen, someone gets dragged in front of Congress, and heads typically roll. Knowing that the tenure of many leadership positions in government agencies are subject to the election cycle, why would anyone in their right mind want to work there? Nonetheless, and again, taken with a grain of salt, I’m far happier that we have a USDA and an FAA and an FCC and an FDA than I would be if we didn’t. The problem, in my mind, occurs when government agencies start to wade into paternalism, where the commercial marketplace is a far better arbiter of value.

Where is all this going? Last Tuesday I was once again privileged to be included in a reception hosted by Health Advances. An excellent panel on Reg Affairs: The Regulatory Minefield: Implications for Global Go-to-Market Strategies. Moderated by Marie Schiller, panelists were:

• Richard Francis, Vice President, Global Commercial Strategy, Biogen Idec
• Ross A. Jaffe, MD, Managing Director, Versant Ventures
• William Pignato, Global Head, Regulatory Affairs, Novartis Molecular Diagnostics
• Patricia B. Shrader, Vice President, Corporate Regulatory Affairs, Medtronic

While a panel on regulatory affairs may seem like a bit of life sciences industry arcana, it was a timely, lively and valuable discussion at a time when FDA is still on the hot seat (think Vioxx), and has made significant changes to an important aspect of medical device regulation (the 510(k) approval process) and is proposing more, and is also proposing to exercise the authority it has heretofore chosen not to in the regulation of “home brew” or laboratory developed tests (LDTs). (It didn’t hurt that the discussion was facilitated by the excellent appetizers and drinks provided by our gracious hosts!) Home brews or LDTs are diagnostic tests that are developed and validated by a particular lab and performed only in that lab. LDTs are regulated by CLIA, a division of CMS, and the current regulatory hurdle for CLIA approval is to demonstrate that the test is testing the analytes you say it is – it has nothing to do with whether or not the test is of any clinical relevance. In contrast, the FDA regulates tests that are developed to be sold in kit form or for use at the point of care, and can prohibit you from marketing it if they feel it is not a clinically valid test.

I asked the group if they thought that when FDA finally regulates home brew (I’m not holding my breath – they’ve been talking about it for as long as I’ve been in the industry, and I’m not about to tell you how long that is…), they would use CLIA as the model, or the paternalistic FDA approach. In fairness, part of FDA’s mandate is to assess risk; however, there are numerous cases, for example within the AIDS and cancer communities, where affected persons are willing to take the risks associated with a new drug, particularly when it represents the only alternative to death.

There are some industry groups, notably the American Clinical Laboratory Association (ACLA) that (predictably) oppose the new level of regulation. Are you sitting down? I’m in favor of it. When I was a motorhead kid, Congress mandated pollution controls on cars, and increases in fuel efficiency. At the time, I had a 1973 Chevy Nova with a 350 engine that got 8 mpg when it was new – worse than my father’s Cadillac with a 472! Classic. Engines with the government-imposed controls did, in fact, produce cleaner emissions, but ended up using so much more fuel getting from A to B, that they created more pollution (after some serious wrench turning and installation of new components, my car averaged 21 mpg and got rubber in three gears). Car makers vehemently opposed the new regulations, saying that the mileage mandates were impossible to achieve. Where are we now? Car companies routinely compete based on mileage, and my diesel averages over 40 mpg.

I’m not surprised that the ACLA opposes the proposed changes. Will it result in delay and ultimately cost the consumer (which, as we continue to move toward a single payor health insurance system, is you and me) more money? Yes. Ultimately, though, it will also keep the “riff raff” out of the business (the mom and pop labs where the lunch is stored next to patient samples in the fridge), and will provide some uniformity by which clinicians can help determine clinical utility. I just hope that it will be done with prudence and follow the European or CLIA model which does not evaluate clinical utility – up to a point. As I said in my earlier post, the commercial marketplace does not always screen out all the products that it should, so some level of government oversight is a really good thing.

Don’t worry – there’s still quite a long way to go before I turn into a complete socialist.