On Wednesday, the House Oversight and Government Reform Committee released a report showing that at least two top FDA officials objected to making changes to federal rules regarding labeling for prescription drugs. The changes, made in 2006, created a new labeling system, with the most important warnings for doctors placed in a "highlights" section at the top of a label's first page. The new rules also banned drug companies from adding warnings to "highlights" sections without prior FDA approval -- a move that critics claim was aimed at pre-empting lawsuits against drug companies. The report from U.S. Rep. Henry A. Waxman, D-Calif., who is chairman of the committee, suggests FDA officials made the changes to follow a Bush administration policy of protecting drug companies.
The report's release comes as the U.S. Supreme Court is set to hear arguments Monday in the landmark Wyeth v. Levine pre-emption case.
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. He chatted about the House report and other issues with The Am Law Daily.
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. Really (U.S. Rep.) Waxman cites two or three individuals who raised objections in an agency of thousands. More important, senior agency officials had to sign off on the regulations before they were adopted. The report just completely ignores that fact.
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: The report suggests the FDA changed the labeling rules under pressure from the Bush administration. It includes an e-mail in which you say the White House wouldn't let the rule changes move forward unless they included language about pre-emption. Is this true?
A: One thing I'm not going to do is comment on internal deliberations we had at the agency.
Q: Okay. So explain the reason behind the rule changes -- behind the idea of the "highlights" section on drug labels and the notion that drug companies shouldn't be able to add warnings to it without permission from the FDA. The internal critics cited in the report said that would slow down the process of updating warning labels.
A: The entire purpose of the "highlights" section was to bring the doctor's attention to the most significant risks related to a drug, and that section is limited, by law, to the top half of the first page of the label. Given that a label might be 30-pages long, it defeats the purposes of the "highlights" section if the company can just keep adding whatever it wants to that section. If you add a new warning, you're going to have to take something out. What people don't understand is that the company can add to the rest of the label. This wasn't an effort to limit a company's ability to add to its warning labels. But before 2006, the labels looked like an accordion unfolding, with font so small you couldn't read it and warnings buried where you couldn't find them.
Q: Before the rule changes, could companies add whatever they wanted to their warning labels?
A: No, and that's the other misconception. A (drug company) could only unilaterally make a change if they had newly acquired evidence of a risk the FDA didn't already have.
Q: But the report makes it sound as if companies were adding warnings without FDA approval -- and that the dissenters Waxman cited were happy about that, since the warnings got to the labels faster.
A: To the extent that that's true, and I don't know that it is, those companies were in violation.
Q: Let's go back to Wyeth. (Am Law Daily ed. note: Diana Levine, the plaintiff suing Wyeth, had most of her right arm amputated after a physician's assistant accidentally injected an anti-nausea drug into an artery, causing gangrene.) 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, and every pharmaceutical company in the U.S. will submit everything for placement on their labels. Over-warning will become a huge problem and a huge burden on the FDA.
Q: No wonder you got out of public service and joined Hunton last year.
A: Ultimately, I was a political appointee who served at the pleasure of the president, and I knew I wouldn't go beyond this administration. I got a great offer from Hunton, and I couldn't turn it down.
This article first appeared on The Am Law Daily blog on AmericanLawyer.com.