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BioPharm Executive: Speaking the Unspeakable


10/30/2012 12:03:42 PM

March 27, 2013

Speaking the Unspeakable

This past December, the U.S. Court of Appeals for the Second Circuit handed down a decision in U.S. vs. Alfred Caronia, overturning a 2009 ruling finding Alfred Caronia--a drug rep for Orphan Medical, now part of Jazz Pharmaceuticals --guilty of a criminal misdemeanor for the off-label promotion of the narcolepsy drug Xyrem. The lower court had taken the standard line in the case, which is that any promotional activity that strays from a drug's approved label is by definition false or misleading. Or put another way, that FDA is the final arbiter of truth.

Here's the thing though: Caronia didn't actually say anything untrue or misleading. He simple talked about things that anyone other than a drug rep is free to talk about. Caronia appealed his conviction on First Amendment free speech grounds and prevailed in the appeals court.

Now, I know what you're thinking: Surely somebody had thought of this free speech angle before, right? Absolutely. While the courts have long given the agency a lot of leeway in how it goes about its mission, the FDA actually suffered a string of legal setbacks in the late 1990s. Here's one representative and juicy quote from the 1998 case Washington Legal Foundation v. Friedman: "In asserting that any and all scientific claims about...prescription drugs are presumptively untruthful or misleading until the FDA has had the opportunity to evaluate them, FDA exaggerates its overall place in the universe."

However, these limitations on the agency were subsequently overturned by the Court of Appeals for the D.C. Circuit in 2000 by Washington Legal Foundation v. Henney (there's a nice backgrounder from the Washington Legal Foundation).

Now Caronia has once again stirred an issue that has never really been settled. One of the more interesting aspects of the story is that, as reported in the Wall Street Journal and elsewhere, FDA has decided to neither retry the case nor appeal it to the Supreme Court. (That doesn't mean the issue may not get pushed to the Supreme Court eventually, but FDA isn't going there now).

Why? Because FDA has long benefitted from--and even relied upon--going around legal obstacles, stepping over boundaries, and avoiding potentially troublesome confrontations in court. In doing what it believes is in the best interests of the public, FDA counts on its regulatory powers to silence industry objections. As University of Florida law professor Lars Noah has detailed, this goes well beyond off-label promotion. His article from the 2008 Cornell Law Review, "The Little Agency That Could (Act With Indifference To Constitutional And Statutory Strictures,") recounts many ways in which FDA has relied on vagaries or simple recalcitrance to get around laws that would seemingly otherwise restrict it.

Given that this new ruling only applies to the three states under the jurisdiction of the second circuit--Vermont, Connecticut, and New York--it looks like FDA would rather ignore the problem rather than get a broader ruling it potentially wouldn't like. So we have an open legal morass.

Drug companies, of course, are delighted with the idea that they may have a freer hand in off-label promotion. Critics, meanwhile, cite this case alongside the controversial Supreme Court decision in Citizens United v. Federal Election Commission, saying it points to a disturbing trend of treating corporations and people as equivalents in terms of free speech. Moreover, they point out that companies free to promote off-label drug uses will no longer bother getting approvals.

Certainly there is a public interest in providing some clear restrictions on how drug companies talk about their products, and to stop truly false and misleading speech. But it's never been clear to me that the public benefits from having discussions about legitimate scientific information silenced. Many critics concerned by the decision make the slippery slope argument that discussing legitimate research will inexorably lead to the promotion of wild, false claims...or they deny the slope altogether and assert that any off-label claims, no matter what they are, are false simply because they are coming from sales reps. Still others still claim that no competent physician actually relies on reps for information (in which case, where's the harm?)

Moreover, it doesn't seem to be in anyone's interest that we continue in the legal limbo that exists now--and frankly, has existed for decades. But that's what we have. After a hiatus, FDA has again begun issuing Untitled Letters regarding promotional claims. The Obama Administration has indicated it will continue to go after off-label promotions. In a February press release, the Departments of Justice and Health and Human Services trumpeted their track records in pursuing healthcare fraud and abuse--for every dollar spent, the government nets $7.90, they said, totaling $4.2 billion last year. In the past, a significant portion of that has come from fines to drug companies. Soon, drug companies may be able to save that money. Then again, they may need it to cover the greater product liability exposure that comes from losing the shield of "FDA approved use."

-Karl Thiel

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