June 12, 2007
Lutterly Lacking
There are two crucial Food and Drug Administration reforms that the House must insist upon as it reauthorizes of the Prescription Drug User Fee Act: First is giving the FDA the power to impose a two-year moratorium on direct-to-consumer advertising for newly approved drugs; the second is the right to insist that the company complete a post-approval clinical trial within a specified period of time or the drug gets withdrawn from the market.
This became clear to me as I listened to the various members of the health subcommittee of the House Energy and Commerce Committee attempt to elicit meaningful responses from Randall Lutter, the deputy commissioner who had been sent up to the Hill to testify. Lutter is a former fellow at the American Enterprise Institute, and has now taken over the reins of the FDA’s regulatory affairs office. He’s well versed in the many proposed guidances that have come pouring out of the FDA in recent months, including one involving conflicts of interest on FDA advisory committees.
Which, of course, is the other major provision that has to be inserted in to the House bill – a complete ban on appointing scientists with ties to industry, not the “one waiver per meeting” policy included in the current version of the bill. The committee also needs to insert a “look back” period for determining conflicts of interest that is at least three years long. There’s nothing on this question in the current bill, and it represents a huge loophole that will render any reform the House passes on this issue moot.
Lutter was woefully underprepared for the meeting. The most entertaining back-and-forth involved Rep. Diane DeGette (D-CO), who at a previous subcommittee meeting had asked the FDA for some data involving medical devices. They were supposed to have responded in writing within a few weeks of the hearing – a typical response at Congressional hearings when the witness can’t immediately put his hands on the information being requested. A month ago, DeGette wrote a follow-up letter asking "where's the data?" When she brought that letter to Lutter’s attention today, he admitted that he hadn’t read it because he hadn’t seen it. It was a graphic portrayal of an administration that is either totally incompetent or contemptuous of the Democrats who now control Congress. Maybe both.
The various Congress-folk took turns trying to pin Lutter down on the different elements of the reform package, which includes establishing risk management plans for new drugs, sending all new drugs to advisory committees, a mandatory clinical trial registry, including results, and smorgasbord of add-ons that run from extending extra patent term to companies that conduct pediatric clinical trials to establishing a new institute within the FDA (named, oddly, Reagan-Udall) that would develop new science to help the agency do its job of protecting the public from unsafe and ineffective drugs and medical devices.
In the Senate, a coalition of broadcast, print advertising and drug industry lobbyists – you know what you call that in Washington? Powerful – succeeded in stripping from the bill language that would have given the FDA the power to limit direct-to-consumer advertising during the first several years the drug is on the market. This is crucial when there are signals in the data at the time of approval that a drug may have harmful side effects. Those signals can only be tested by an appropriately designed clinical trial, and until the results are in, the drug should diffuse slowly, like in the old days before DTC was allowed.
The argument made by the lobbyist coalition that a lawfully imposed moratorium would violate commercial freedom of speech suggests the public’s interest in protecting the public from needless exposure to a potentially life-threatening events (heart attack and stroke in the cases of Vioxx and Avandia) is outweighed by the First Amendment. I was a reporter for 20 years. I don’t think so. Oliver Wendell Holmes understood that freedom of speech isn't absolute – the famous yelling fire in a crowded theater illustration. It seems to me that protecting public health is one of those situations where the rights of commercial speech do not hold sway.
The FDA also needs a new weapon to ensure the trials get done during this moratorium period. That's where the threat of losing the drug’s tentative approval comes in. Companies have failed to start or complete hundreds of trials that were ordered by the FDA. These post-marketing trials are supposed to test whether the hints of harm in the pre-approval trials was real or just a statistical fluke. If it is real and the risk outweighs the benefits of the drug (Vioxx was just another pain pill; and Avandia, the latest drug in the dock, is just another blood sugar lowering drug), then the drug can be withdrawn before too much harm had been done. And what if the signal turns out negative? Then it can begin marketing the drug to a mass audience, if that is part of the corporate strategy.
There’s a number of other pressing issues that should be included in the bill during the mark-up session, which takes place Thursday. For instance, scientists at the agency should be protected if they go public with safety concerns, and they should be given the right to publish and speak independently. Rep. Jan Schakowsky asked Lutter about the recent case involving the scientist who tried to issue a warning about Avandia a year ago, but was told by her higher-ups at the agency to sit down and shut up. Schakowsky also mentioned the case of David Ross, who recently departed for the Veterans Administration after blowing the whistle on Ketek, an antibiotic with dangerous side effects.
“We take these concerns very seriously,” Lutter said. “I am unfamiliar with their cases.” There was a lot he was unfamiliar with Tuesday.
Meanwhile, the Republicans pressed an opening handed to them by whoever stuck an anti-preemption clause into the bill. This would not allow companies to use, as a defense in drug safety suits, the excuse that they complied with all the FDA regulations. (The failure to warn is the essence of many if not all product liability cases.)
I’m not up on the intricacies of this issue, but I do know this: in more than a year of talking about, writing about, and lobbying for FDA reform, this never came up. Why now? If this has something to do with undoing the handiwork of Dan Troy, the drug industry corporate lawyer who ran the FDA’s legal counsel office early in the Bush administration, then those issues ought to be fully discussed. Something that has far-reaching implications shouldn’t be snuck into a bill at the last minute, which appears to have happened in this case.