Judicial Non-Deference to the FDA

Written by Rebecca Zietlow on March 26th, 2009

The Food and Drug Administration has been taking it on the chin in the courts – and for good reasonfinal1.jpg.  For years, it has been apparent that the FDA process for approving and evaluating drugs is flawed.  Far too many drugs have been approved only to be recalled due to deadly side effects that were uncovered only after the drug’s approval.  This problem has gotten so bad that recently, one of my doctors told me that he waits a year after a new drug is approved by the FDA before he prescribes it.  The doctor said that he waits a year in order to ensure that the drug is safe and find out more about the drug’s side effects.  Removal of approved drugs from the market is surely embarassing to FDA officials, but it is profoundly disturbing to those of us who are potential users of those drugs.   It is also evidence that things are not working right at the FDA.  Maybe the drug industry has too much power, and maybe the agency has become too politicized.

In two recent high profile cases, courts have confirmed that the FDA’s decision making process is problematic.  In Wyeth v. Levine, the United States Supreme Court upheld a state court judgment against a leading drug company and in favor of a patient who lost her arm because her doctor used the risky “IV push” method to administer a drug to her.  Wyeth sold the medication with a label did not warn against using the IV push method.  The SCOTUS rejected the company’s argument that the claim was preempted by the FDA’s approval of its label.  Under the Bush administration, the FDA had changed its regulation to provide that “FDA approval preempts contrary or conflicting state law.”  However, the Court held that the new regulation had no authority because it was contrary to the legislative history of the Food and Drug Act, because the FDA had finalized the regulation without giving states or interested parties any opportunity to comment on the change, and because the FDA had failed to provide any reasoned explanation for overturning its long standing policy of non-preemption.  Why would the FDA unilaterally act to preempt state tort claims against drug companies?  It doesn’t take a rocket scientist to figure out that the Bush administration FDA wanted to protect drug companies from lawsuits regardless of the cost to public health.

This week, a New York federal district judge overturned an FDA regulation prohibiting girls under the age of 18 from purchasing the controversial “morning after” pill without a prescription.  The court held that the FDA’s rule was entirely unsupported by scientific evidence, and that there was strong evidence that the rule was based not on science, but on politics.  Why would the Bush administration FDA want to raise the age limit for girls to buy this form of contraception without a prescription?  The “morning after” pill is a hot button issue in the conservative “right to life” movement, a key constituency of President Bush.

We deserve a government that works, and a Food and Drug Administration that bases its policies on protecting our health, not protecting drug companies or religious principles.  Thank goodness our courts are doing what they can to make the FDA accountable for its shoddy performance.


1 Comment

Comment by Joel
2009-04-09 02:46:07

“It doesn’t take a rocket scientist to figure out that the Bush administration FDA wanted to protect drug companies from lawsuits regardless of the cost to public health.”

Right… because drug companies inflict such a great “cost” to the public health. Now, this just be my twisted logic here… but isn’t the PUBLIC COST greater when trial lawyers go crazy suing drug companies!?

On an unrelated topic… do we really deserve a government that works? I mean, it’s a nice thing to say… but I think it would be more accurate to say that we deserve the government we elect… and the kinds of regulatory bodies we create. If we create/elect bad government, why would we deserve anything better? Just a thought.

best,
Joel

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