Be careful what you wish for…


Recently, the Supreme Court heard arguments in Wyeth Vs. Levine.  This case has some import to the general public, but it has incredible impact on FDA regulated companies.  And that impact is just about exactly opposite of what Wyeth (the drug manufacturer defendant) expects.  In this case, to win is to lose.  Big. I work in the Medical Device industry, regulated by the FDA, audited by the FDA, and I understand how the system works today.  If Wyeth wins their case, it may grind the drug and device industries to a halt.

Basically, Wyeth is claiming that since the FDA approved their label, they are absolved of any further responsibility in making sure that label was effective.  Some background: A woman (Levine) lost her arm due to infection caused by side effects from how the doctors delivered Wyeth’s medication.  She claims the warnings on delivery methods were insufficient.  Rather than simply argue that they actually were sufficient, Wyeth claims that since the label was judged “effective” and “accurate” by the FDA, Levine has no grounds to sue.  (This is an oversimplification, but it highlights the key issue. And lest you think “but no one could fit all those warnings on an itty-bitty label, “Labeling” to the FDA means all documentation provided with the drug or device.)

If Wyeth wins, it will be a Pyrrhic victory for this reason: right now the FDA relies heavily on industry to evaluate the safety and efficacy of its own products (and this is a ‘good thing’ as I think will become apparent below).  To a large extent, what the FDA does is make sure you have an adequate process to evaluate and mitigate risk, and make sure you followed it.  Again, I’m oversimplifying but that’s the crux – if you demonstrate good process and accept responsibility, the FDA starts out assuming that your declarations are good, and only checks to see if there is evidence that they are not. If Wyeth wins, the burden of responsibility shifts – the FDA must assume that your declarations are inadequate and must dictate corrections.  This will devastate the industry.  It will cripple American medical innovation, and the American drug and device approval system, long considered the gold standard throughout the world, will grind to a halt.  The European equivalent will become dominant, because only it will be able to move drugs and devices through the process.

I hate to be over dramatic in these writings, but re-reading the above, I can’t find fault with what I wrote.  The FDA simply does not have the number of people, nor the type of people to analyze every specific claim.  The people who can do that the best are the drug and device manufacturers and the trust between industry and FDA is one of the most valuable assets those manufacturers hold.  For the sake of winning a single lawsuit, Wyeth is throwing this away, not just for themselves, but for every other manufacturer.  They have been given tragically wrong advice from their legal departments. After working Congress for years to pressure the FDA to speed up the approval process, resulting in real gains, gains that translate into helping people NOW rather than several years after they die, a Wyeth win will single handedly roll back back those gains.  Because if the FDA granting approval absolves manufacturers of liability, then the FDA is obligated to make sure it understands and approves all the data.  That it keeps current with all the complaints and incident reports and checks them against labeling.  That it has the expertise and cognizence to be the primary checker of safety rather than the ‘guardians of the guardians’.  It’s not even possible.  There are thousands of drug and device manufactures, millions of people working on these issues, and an FDA that ensures those manufacturers and people are doing everything they can to ensure safety, is the best FDA we can imagine. To shift this to “if we can get it past the FDA we absolve ourselves of responsibility” puts such an adversarial role on the government that we may never get another life saving drug or technology out into the market.

Imagine you are that FDA employee.  The Supreme Court states that once you approve something the FDA is responsible, which means that YOU are responsible.  Your signature takes upon your conscience the woman who lost an arm, the family that lost a mother, the straight A son who becomes a vegetable.  You are not a doctor, a surgeon, a specialist in drug reactions.  How long will it take you to sign on the dotted line?


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