United States: FDA Marketing: PAR V US – "Pay No Attention To The Man Behind The Curtain" - Why Is The Government Trying To Strike Its Own Statements From The Public Record?

Last Updated: April 2 2013
Article by Michael A. Walsh

On March 5, 2013 the Department of Justice issued a Press release announcing "Par Pharmaceuticals Pleads Guilty and Agrees to Pay $45 Million to Resolve Civil and Criminal Allegations Related to Off-Label Marketing." The plea and agreement to a 5 year Corporate Integrity Agreement resolved criminal and civil liability for promotion of a prescription drug approved for weight loss in AIDS patients but "marketed" for the unapproved use of geriatric wasting. But now the government is seeking to strike from the public record how it "defined" off-label promotion in its communications with PAR.

The Settlement also resolved the action PAR v. US (PAR's Action), an action filed by PAR seeking declaratory relief prohibiting "FDA's unconstitutional and invalid regulations" restricting truthful non-misleading speech. Par Pharm., Inc. v. U.S. No. 11-cv-01820-RC, (D.D.C. filed October 14, 2011), ECF No. 1. More than a year ago, the government sought to dismiss the PAR Action and submitted a declaration of Dr. Rachel Sherman, Associate Director of Medical Policy and Director of the Office of Medical Policy (OMP) at the Center for Drug Evaluation and Research (CDER) at FDA. In the Declaration, the FDA purports to "describe ... FDA's procedures and policies with respect to the communication of promotional information about off-label uses." Id., ECF No. 14, p. 1. "Describing" its procedures and policies, FDA suggests that compliance with the law can be evidence of illegal conduct stating:

FDA does not consider a manufacturer's truthful and non-misleading speech to healthcare professionals concerning the approved use of an FDA-approved drug as establishing, by itself, a manufacturer's objective intent that the drug be used for an unapproved use.

Nor does FDA regard a manufacturer's knowledge that an FDA-approved drug was being prescribed by healthcare professionals for an unapproved use as establishing, by itself, a manufacturer's objective intent that the drug be used for an unapproved use. Id., ECF No. 14, p. 7.

While purporting to "describe its procedures and policies," FDA provided no information explaining what evidence will suffice to render "truthful speech" or knowledge of facts illegal stating: "determining ...the manufacturer's 'objective intent,'... can be based on ... the circumstances surrounding the drug's distribution ... and may include "additional evidence suggesting ...a deliberate strategy to encourage off-label prescribing." Id., ECF No. 14, p. 8.

Not surprisingly, PAR filed a motion seeking to depose the FDA on the statements in the Declaration, stating:

These statements which cannot be found in any FDA regulation or other official agency issuance raise more questions than they answer. The Government tellingly does not explain how a company could ever engage in speech consistent with Dr. Sherman's 'by itself,'; i.e. without some 'additional evidence' that the government has left open...." Id. at 1:11-cv-01820, Doc 23 at pg. 1-2.

The Government's Impenetrable Cloak of Transparency

In its motion to depose the FDA, PAR went on to detail conversations with DOJ that shed significant light on how the government defines "off-label" promotion, revealing startling facts in how the government prosecutes an off-label promotion case:

The Government has conveyed to Par positions inconsistent with Dr. Sherman's assurances time and again in meetings throughout 2010 and 2011 between one or more of undersigned counsel and Government agencies... For example:

  • At meetings on April 29, 2010 and July 28, 2010, attorneys with the New Jersey U.S. Attorney's Office and FDA questioned Par about promotion of Megace® ES in oncology and long-term care settings. The discussion focused on questions such as how Par could legally promote the use of Megace® ES for AIDS in those settings without first verifying the number of AIDS patients there.
  • In a telephone conference on September 2, 2010, prosecutors with the New Jersey U.S. Attorney's Office acknowledged that certain Par marketing materials related to the on-label use of Megace® ES, but said that fact did not absolve Par of wrongdoing if the communications went to physicians who had prescribed Megace® ES for off-label uses.
  • During a meeting on June 21, 2011, officials with the U.S. Attorney's Office, FDA, and DOJ Civil Fraud Section repeatedly suggested that the legality of promotional speech about Megace® ES turned on the number of AIDS patients the doctor treated. A senior DOJ official also indicated that promotion consisting of on-label speech that takes place in a setting where off-label use occurs is not protected by the First Amendment and, if Par believed otherwise, the issue would need to be litigated. The senior DOJ official further indicated that the Government's view regarding the constitutionality of its position would not change unless and until a court told them otherwise.
  • At a meeting on September 20, 2011, officials from DOJ Civil Fraud, in the presence of HHS OIG and U.S. Attorney's Office representatives who did not dissent, characterized the presence of Par sales representatives in long-term care facilities as inherently constituting off-label promotion regardless of whether the content of the speech related to on-label or off-label uses.

See PAR Pharmaceutical, Inc. v. US, 1:11-cv-01820 Doc 23 filed 3-23-12, Plaintiff's Reply Memorandum in Support of Motion for Limited Discovery at pages 10-11.

Closing the Lid on Pandora's Box

What the DOJ did not mention in its Press Release announcing its settlement with PAR is that it is seeking to have the court strike from the record the statements referenced in PAR's motion for a deposition. The DOJ's request is not based on a claim by the DOJ that the statements referenced by PAR are not accurate or not truthful, but rather, that the DOJ wanted to keep its approach to criminalizing potentially protected speech secret.

Over the past 10 years the government's overwhelming enforcement power and unfettered discretion to define, criminalize and prosecute conduct it deems violative of the FDCA has produced rare instances where it has been required to define the conduct it deems criminal. PAR is among those rare instances where the government was forced to speak and the Government spoke in tongues. But where PAR documented comments by the government in its motion seeking to depose the FDA, the government seeks to strike its statements from the record.

There are precious few opportunities for courts to hear and decide the Due Process and First Amendment issues raised in cases such as the PAR Action. The Par Action was one of only three recent cases (Par, Caronia and Harkonen) with a chance of advancing the constitutional issues to the Supreme Court but the settlement of PAR, the government not appealing its loss in US v Caronia, leaves only US v Harkonen as the slim chance that these issues will get to the Supreme Court anytime soon.

Why is the government trying to strike its own statements from the public record? Because its statements demonstrate the regime for prosecuting off-label promotion runs afoul of Due Process and First Amendment protections. For now and the foreseeable future, in off-label enforcement proceedings and prosecutions, when the government says jump, industry will continue to say, how high?

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Michael A. Walsh
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