Looking out for No. 1
The FDA objects to pre-emption but not for the reasons you might hope
Back in July, I told you about pre-emption — a policy that would make it impossible for consumers who have been harmed by prescription drugs to take legal action against drug companies (7/31/08 eTip, subject line “Pre-emptive strike”). It’s been a hot topic of debate for years, and is currently in the hands of the U.S. Supreme Court. But last month, there was a surprising twist in the case when the FDA announced that it objects to pre- emption.
What’s that? Could the FDA finally be loosening its ties with Big Pharma and taking the best interest of the American people to heart?
Well, remember that old saying “If it sounds too good to be true, it probably is”?
The FDA can try to spin it any way it wants, but the fact is, their “objections” to pre-emption are a thinly veiled attempt at looking out for No. 1 — not for you and me.
You see, if the Supreme Court lets Big Pharma off the hook for the dangerous side effects of their drugs, the FDA will find itself under even more scrutiny than it’s been subjected to lately. After all, the whole basis of pre-emption is that the FDA is the only body with the authority and expertise to evaluate the safety of pharmaceuticals, and once the agency has approved a drug, no one else can question it (at least not by way of legal action) — regardless of what horrors it might cause later.
While I think that Big Pharma should be shouldering some of the responsibility that pre- emption would eliminate, ultimately, the FDA SHOULD be the authority on drug safety – - that’s its job! And it’s more than a little disturbing that the idea of being held accountable for it has the organization running scared. Even worse, the FDA fully admits that they don’t even do a good job of it now.
According to the head of the FDA’s Office of New Drugs: “Much of the argument for why we are proposing to invoke preemption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date… We know that such an assumption is false. We know that many current approved drug labels are out of date and in many cases contain incorrect information. It is unwise to suggest that FDA approved labeling is always up-to-date and always contains a full and complete listing of all pertinent risk information.”
Hmmm does it bother anyone else that the FDA freely states that it’s well aware that “many” of the drugs it has approved have incorrect labels? And that the agency is actually using this fact to defend itself against pre-emption?
Between the underhanded practices of Big Pharma and the utter ineptness of the FDA, pre-emption is quite possibly the worst idea I’ve ever heard of.
Let’s hope the Supreme Court agrees.
Source:
“FDA staff objects to preemption policy: Report,” Pharmalot.com (www.pharmalot.com), 10/29/08
