Skip to main content

Cross-posted from Tort Deform

by Professor Henry Greenspan

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.  

Originally posted to TortDeform com on Wed May 16, 2007 at 11:48 AM PDT.

EMAIL TO A FRIEND X
Your Email has been sent.
You must add at least one tag to this diary before publishing it.

Add keywords that describe this diary. Separate multiple keywords with commas.
Tagging tips - Search For Tags - Browse For Tags

?

More Tagging tips:

A tag is a way to search for this diary. If someone is searching for "Barack Obama," is this a diary they'd be trying to find?

Use a person's full name, without any title. Senator Obama may become President Obama, and Michelle Obama might run for office.

If your diary covers an election or elected official, use election tags, which are generally the state abbreviation followed by the office. CA-01 is the first district House seat. CA-Sen covers both senate races. NY-GOV covers the New York governor's race.

Tags do not compound: that is, "education reform" is a completely different tag from "education". A tag like "reform" alone is probably not meaningful.

Consider if one or more of these tags fits your diary: Civil Rights, Community, Congress, Culture, Economy, Education, Elections, Energy, Environment, Health Care, International, Labor, Law, Media, Meta, National Security, Science, Transportation, or White House. If your diary is specific to a state, consider adding the state (California, Texas, etc). Keep in mind, though, that there are many wonderful and important diaries that don't fit in any of these tags. Don't worry if yours doesn't.

You can add a private note to this diary when hotlisting it:
Are you sure you want to remove this diary from your hotlist?
Are you sure you want to remove your recommendation? You can only recommend a diary once, so you will not be able to re-recommend it afterwards.
Rescue this diary, and add a note:
Are you sure you want to remove this diary from Rescue?
Choose where to republish this diary. The diary will be added to the queue for that group. Publish it from the queue to make it appear.

You must be a member of a group to use this feature.

Add a quick update to your diary without changing the diary itself:
Are you sure you want to remove this diary?
(The diary will be removed from the site and returned to your drafts for further editing.)
(The diary will be removed.)
Are you sure you want to save these changes to the published diary?

Comment Preferences

Subscribe or Donate to support Daily Kos.

Click here for the mobile view of the site