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Henry Greenspan

We Are All the Mitten State - FDA Preemption and the Lipstick Problem

Last week, the U.S. Senate passed the "FDA Revitalization Act" (hereinafter, FDARA) by an overwhelming majority (only Bernie Sanders of Vermont voted 'nay'). That ought to tell us something. Clearly, the pharmaceutical industry and both major parties found something they could all agree upon: the usefulness of lipstick.

In order to understand this victory for cosmetology, a bit of context is needed. For the past six years, the industry and its allies have done everything possible toward making FDA preemption the law of the land. That is, the goal has been to turn Michigan's drug industry immunity law – which fully shields drug companies from civil liability if their product is "in compliance" with FDA regulations – the national standard. There has never been any secret about this; Michigan has been designated "the model" by every preemptor from Daniel Troy, who is to FDA preemption what James Brown was to soul, to every law firm that defends pharma from product liability claims.

One of the most common arguments against FDA preemption has been the sorry state of the FDA itself. Thus, people who are rightfully terrified at the prospect of the FDA being the only institution in the country that could hold drug companies accountable have pointed to the mountain of studies that agree about the inadequacy of the FDA's drug safety system. I have argued that, serious as the FDA's problems are, they are also beside the point as far as preemption is concerned. Even a utopian FDA has no jurisdiction over many of the delinquencies that become relevant in civil liability.

But here we begin to understand why the industry and its allies were so gung ho on FDARA. Inevitably, they will insist that now the FDA's problems have been solved. The argument about its failings has now been met. Ding, dong, the witch is dead.

Here is why the Munchkins' enthusiasm is misplaced. The reasons why fall into two major categories.

First, there are the limits of FDARA itself. In order to get it passed, so many compromises were included that it changes the actual situation at FDA hardly at all. As a single example, a proposed ban on direct-to-consumer advertising during the first two years a drug is on the market (initially supported even by Bill Frist) was simply tossed out. It is that initial marketing blitz which creates "blockbusters" - an all-out PR offensive during what is called the "evidence-free zone"; i.e., before whatever problems may be out there begin to hit the fan. Instead, FDARA would impose fines of $150,000 if, in the FDA's judgment, a company uses advertising that is "false and misleading." Let's be clear what $150,000 means in the context of the pharmaceutical industry. Vioxx made $2.5 billion per year, even after all the now famous label changes were in place (which, by the way, affected its sales not at all). So, under the new regime, a company could use ads that lied all their way down the Yellow Brick Road, and the entire fine – were it to be levied at all – would be what a drug like Vioxx made in less than a day (roughly, what the drug made every eighteen hours).

Second, and more central to the issue of FDA preemption, there remains a wide range of potential delinquencies relevant in civil litigation but over which the FDA – even in its most "revitalized" incarnation – has no authority whatsoever. Staying with Vioxx, for example, we learned that there was an orchestrated campaign to threaten and intimidate academic researchers who did not see things the company's way. Tactics like those may profoundly influence what does and does not become known about a drug's safety, but they have nothing to do with whether a company is "in compliance" with FDA regulations. They are not within the FDA's jurisdiction at all.

We have also learned that data may be skewed, even excised, in ways that impact what is published in major medical journals. These are the sources of information upon which physicians rely. Again, however, the FDA has no authority whatsoever over the editorial policies of those journals. Indeed, in a now well known article about Celebrex published in the Journal of the American Medical Association – in which, it turned out, half the data was simply left out – the most seasoned medical reviewer at the FDA, Dr. Robert Temple, noted "when the JAMA article comes out and confirms the hype, that probably has more impact than our labeling does." Unfortunately, even if we had the most "revitalized" FDA imaginable, there would remain very large arenas for potential intimidation, misinformation, and hype.

That is why there is no FDA reform conceivable – and even less what was just passed by the Senate – that would substitute for the accountability that civil liability makes possible. The two systems complement each other; they do not cover the same ground. And that is why, when the FDA preemption gang starts to invoke that bill to suggest that FDA's problems are now solved, we should not be distracted. We should not confuse the pig, when there is one, with the lipstick.

Henry Greenspan: Author Bio | Other Posts
Posted at 2:19 PM, May 16, 2007 in
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Comments

The FDA is, has always been, and will always be, a rubber stamp for the drug companies..Period ! Merk has still not taken responsibility for Vioxx and Pfizer is advertising celebrex again..... I had a heart attack eighteen months after I started taking Celebrex.....Now I live with an irregular heartbeat...I have to take heart medication twice a day...I could have died..I am waiting for Pfizer to own up..They don't care-they just want to make money and we're the guinea pigs

Posted by: Don Hughes | May 16, 2007 6:15 PM

Don - Needless to say, I am sympathetic with your views and also with your situation. I would just say that there have been important phases in the FDA's relationship with industry. Check out Philip Hilts' _One Hundred Years of Regulation_ sometime if you're interested. You will find the whole gamut among FDA commissioners - cowards, combatants, and everything in between.

The core issue, in my view, is not the FDA but Congress. Every time Congress moves toward making the FDA what it could be, it balks - whether by withholding funding, authority, or both.

In the meantime, even if the miracle happened that we actually got the FDA we need (dream on...), we would still also need civil liability, which is the core point of my piece.

Posted by: Henry Greenspan | May 17, 2007 1:54 AM