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BioPharm Executive: No Sleep, But Plenty of REMS



10/27/2009 12:16:44 PM

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No Sleep, But Plenty of REMS

When David Letterman went public with his sordid story of adultery and blackmail a few weeks ago, a few media outlets raised an interesting question: Why, exactly, is blackmail illegal? The individual acts behind typical blackmail--threatening to publicize embarrassing information and alternatively being paid not to publicize information--are both perfectly legal. Making a crime out of legal activities that transpire in the wrong order (solicitation of payment being the key) seems, from a certain perspective, a bit tortured.

I had a similar feeling when I recently read about Allergan's federal lawsuit against the Food and Drug Administration, seeking a ruling that would allow them to discuss off-label uses of Botox with physicians.

Why, exactly, is off-label promotion illegal? Or more specifically, why does the prohibition not interfere with First Amendment rights? I'm not a lawyer, so perhaps there are clearer legal arguments than I realize. But if that's the case, they've apparently never been tested in court before--no company that I know of has has raised First Amendment objections to FDA's off-label promotion rules before this.

What makes it more interesting is that Allergan is trying to shake off the shackles of government regulation just as FDA tries to clamp down further. The catalyst for the lawsuit was FDA's demand, made in September, that Allergan institute a Risk Evaluation and Mitigation Strategy (REMS) for Botox. Under the FDA Amendments Act of 2007 (FDAAA), the agency has broad discretion to require a REMS--a formal plan that must be submitted to the agency and approved--if it feels public safety requires one.

For Allergan, this requirement highlights the difficult line that many companies are regularly forced to walk, and that in Allergan's case may be well-nigh impossible. Much of Botox's use is off-label, so how can the company effectively discuss and mitigate risks without actually being able to talk about how the drug is really used? One can imagine some absurdist theater as the company tries to mutely navigate the process as currently regulated. It will be fascinating to see what the courts have to say.

- Karl Thiel

Read the BioPharm Executive online newsletter October 2009.

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