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Unapproved drug marketing or free speech?

Thursday, April 29th, 2010



A Delaware pharmaceutical company will pay a half billion dollars in fines for promoting one of its medications for uses that the FDA has not approved. But some groups say the company did nothing wrong because marketing is an expression of free speech.

Medications may work for uses that aren’t approved by the FDA. But companies aren’t allowed to promote them for unapproved uses.

Richard Samp wants to put an end to that. He is chief counsel with the Washington Legal Foundation. His group is suing the federal government for jailing a sales rep who urged doctors to prescribe non-approved uses of a drug.

Samp: When FDA has no reason to think that the speech that it is concerned with is in any way false, then FDA has no business trying to suppress it.

Marketing speech is protected by the First Amendment. But the government still has the ability to regulate what companies can say.

Daly: I think in a way what it will come down to is, how’s the public’s health best protected?

Erin Daly is a professor at Widener School of Law.

Daly: There are good arguments on both sides.

Companies say more communication will help doctors and patients make treatment decisions. But if companies can promote drugs for unapproved uses, why go through the expensive approval process? Roger Dennis is the dean of the Earle Mack School of Law at Drexel University.

Dennis: That’s the theory of why this would not be protected commercial speech. That the FDA system of having drugs be approved for efficacy and safety you’d just be driving a truck through that scheme by allowing off label marketing.

Dennis says if FDA approval is compromised – so is public safety. But it could take years for the federal courts to resolve this issue.

Despite the current law, off-label marketing appears to be fairly common. The federal government has recovered billions of dollars in fines in the last two years from companies caught in the act.


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