The information dissemination provisions in the FDA Modernization Act do not provide "carte blanche" for manufacturers to promote drugs off-label, the Department of Justice said in a recent letter to the Washington Legal Foundation.

The 1997 legislation "does not give drug manufacturers carte blanche to promote drugs for off-label uses by any means; nor does it create vast exceptions that render the [FD&C Act] or the federal anti-kickback statute inapplicable to pharmaceutical manufacturers," Assistant Attorney General Peter Keisler said in a letter to the Washington Legal Foundation.

Keisler was responding to objections raised by WLF Senior VP-Legal Affairs David Price about prosecutors' public statements on potential avenues for off-label promotion cases.

WLF was the litigant in the 2000 case that challenged FDA's regulation of off-label promotion on First Amendment grounds.

The case ended when FDA agreed that the FDAMA information dissemination provisions would provide a "safe harbor" from prosecution - although the boundaries of permissible conduct beyond that remain uncertain (¹ Also see "WLF Appeals Court Decision Leaves Free Speech Question Open" - Pink Sheet, 14 February, 2000., p. 3).

DoJ told WLF it analyzes specific cases on their own merits, applying well-established legal principles about the boundaries of commercial speech.

"The Department does not have theoretical views regarding off-label promotion of products subject to regulation by" FDA, Keisler wrote.

Instead, "the Department applies the law to the facts of actual cases and, as a result, there is no need for pure analysis of off-label promotion."

DoJ recognizes that "once a drug has been approved by FDA for a medical condition, a health care practitioner may lawfully prescribe the drug for any use, regardless of whether FDA has determined that drug to be safe and effective for that use."

"We agree that reprints of medical journal articles, reference textbooks, and independent continuing medical education can be beneficial to health care practitioners and their patients," and recognize "that the First Amendment protects commercial speech," Keisler said.

However, DoJ "must investigate, and, where appropriate, prosecute the illegal marketing and promotion of off-label uses."

"As you know, it is well-established that the First Amendment does not protect false or misleading commercial speech."

For example, the Neurontin off-label case "involved false or misleading promotional claims about the safety and effectiveness of an FDA-regulated product and the provision of lavish gifts and other kickbacks intended to induce physicians to promote and to prescribe the drug for off-label uses," Keisler said.

Pfizer settled state and federal investigations into Warner-Lambert's promotional practices for Neurontin in May (² Also see "Pfizer To Monitor Off-Label Drug Use Under Neurontin Settlement" - Pink Sheet, 17 May, 2004., p. 3).

Prosecutors cited the initial rulings in the Neurontin case as establishing a clear path to prosecute off-label promotion cases despite the WLF ruling (³ Also see "Neurontin Ruling Is Guide For DoJ Off-Label Promotion Cases – Prosecutor" - Pink Sheet, 13 October, 2003., p. 15).

WLF, however, believes that the public statements by prosecutors to that effect are themselves interfering with scientific exchanges.

In an Oct. 19 response to Keisler, WLF disputed his statement that DoJ does not offer analyses of off-label promotion in the abstract, and argued that prosecutors' public statements on the issue are themselves affecting free speech.

"I would like to disagree respectfully with your statement that the Department cannot engage in 'pure analysis of off-label promotion' or discuss the issue outside of completed cases," WLF wrote.

"From our vantage point, Justice's novel theories of liability and heavy-handed public statements are chilling speech and are having a negative effect on the ability of patients and doctors to receive information about important therapies."

Off-Label Promotion Remains Vulnerable To Prosecution, DoJ Says

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