Former FDA Lawyer: Congress Trying to Sway High Court in Wyeth

[WSJ_law_blog]

You have to admit it: the timing was awfully convenient. As we noted, this week Henry Waxman (D., Calif.), the chairman of the House Oversight and Government Reform Committee, released documents showing that career officials at the FDA had dissented on the issue of the FDA blocking consumer lawsuits against drug makers.

In Wyeth v. Levine, the big preemption case that will be argued before the High Court on Monday morning, the FDA plans to argue that federal drug-approval and warning-label standards should trump stricter state laws. But two FDA officials said in the memos released by Congress on Wednesday that it’s wrong to assume that FDA-approved drug labels are completely reliable, or that they are based on full disclosure of safety risks by drug makers.

So is Congress, in releasing the docs the week prior to oral arguments, trying to sway the case? One person thinks so — the former chief counsel of the FDA. Sheldon Bradshaw, now a partner at Hunton & Williams, oversaw the labeling-regulation overhaul in question during his stint as the FDA’s chief counsel from 2005-2007. AmLaw has a great interview with Bradshaw (pictured). Here are some of the highlights:

Q: What’s your initial reaction to the House report?

A: My reaction is that frankly the report grossly exaggerates the level of dissent among career officials to the new regulations . . . Waxman cites two or three individuals who raised objections in an agency of thousands.

Q: The report basically accuses the FDA of adopting a pro pre-emption stance to help drug companies in litigation. Do you think Waxman intentionally released it so close to the Wyeth arguments?

A: Clearly. Its sole purpose is to sway the Court in Wyeth v. Levine. And there’s irony in that, since the report criticizes the FDA for advancing pre-emption in order to prevail in litigation. That’s exactly what this report is intended to do.

Q: Let’s go back to Wyeth. The drug’s label warned that injection into an artery could cause gangrene (though it didn’t rule out using an injection into a vein), and the FDA had approved that label. So what is Diana Levine’s claim?

A: The plaintiff is saying there should have been a warning on the label saying never to use the injection technique. But what Waxman doesn’t appreciate is that if the Court rules for Levine and says the company should have added that warning without FDA approval, it will open the flood gates . . . Over-warning will become a huge problem and a huge burden on the FDA.