Responsibility for coordination of federal off-label promotion investigations should be transferred to the Department of Justice Criminal Division to help ensure appropriate protection of First Amendment rights, the Washington Legal Foundation said in a recent petition to DoJ.

"It is absolutely critical that federal prosecutors speak with one voice and articulate clear standards regarding what sorts of promotional activities merit criminal prosecution," WLF said in a March 24 ^FDL-1 petition.

"Unless government officials have reason to challenge the truthfulness of manufacturer speech, any effort to regulate such speech raises significant First Amendment concerns."

Currently, DoJ's Office of Consumer Litigation is responsible for coordinating investigations by U.S. Attorneys into off-label promotional activities.

"However, WLF has received information from multiple sources indicating that OCL is not up to the task and has done little to develop a coherent federal government policy regarding when such criminal investigations are warranted," the petition maintains.

"Despite the large number of on-going...investigations into pharmaceutical marketing practices, OCL has failed to bring together relevant federal officials to hammer out a uniform interpretation of the FD&C Act and False Claims Act," WLF said.

"The broad interpretations of those statutes being pushed by some [U.S. Attorneys] appear to be inconsistent both with congressional intent and with First Amendment contours as outlined by federal courts in Washington Legal Foundation v. Friedman," the petition declares.

The 2000 WLF v. Friedman case led to a ruling that FDA's regulation of the dissemination of off-label information in reference books, journal articles and continuing medical education seminars is overly broad, although an appellate court vacated the ruling based on FDA's assurances about its approach to enforcement (¹ Also see "Off-Label Promotion Remains Vulnerable To Prosecution, DoJ Says" - Pink Sheet, 1 November, 2004., p. 28).

However, "WLF is aware of several high profile criminal investigations that target precisely the types of promotional activities that WLF v. Friedman deemed constitutionally protected," the group said May 6.

One case that WLF has publicly raised questions about is a recent settlement in which Pfizer paid $430 mil. to resolve claims about off-label promotion of the anti-epileptic Neurontin (² Also see "Pfizer To Monitor Off-Label Drug Use Under Neurontin Settlement" - Pink Sheet, 17 May, 2004., p. 3).

Nevertheless, WLF maintains, when U.S. Attorneys "have informed OCL of their planned investigations of manufacturer promotional activities, OCL routinely has granted its approval - apparently without detailed consideration of First Amendment and statutory construction issues."

"Most disturbingly, our information indicates that this approval is being granted without any input from FDA," WLF said.

"With its expertise in health care issues, FDA is in a far better position than are federal prosecutors to evaluate the ramifications of undertaking a criminal investigation of a company's promotional activities," WLF said.

"FDA broadly supports widespread dissemination of truthful information about off-label uses of FDA-approved products," the group added.

The petition continues a back-and-forth between WLF and DoJ about the appropriate approach to off-label promotion oversight.

WLF wrote to the department in 2004 complaining that prosecutors were pushing the envelope on First Amendment issues.

The DOJ, however, told WLF that it does not believe the WLF v. Friedman settlement provides a "carte blanche" for manufacturers to promote drugs off-label.

The FDAMA information dissemination provisions do "not give 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," DOJ said in a 2004 letter to WLF (³ Also see "Prosecutors Remain Aggressive In Investigating Off-Label Drug Promotion" - Pink Sheet, 29 November, 2004., p. 23).

Off-Label Promotion Cases Need Better Oversight In Justice Dept., WLF Says

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