Update March/April 2005
This article is comprised of three parts: a letter from the Department of Justice (DOJ) to the Washington Legal Foundation (WLF), WLF’s letter in response, and an author’s commentary in reaction to both. The letters are reprinted here from text provided to Update by the WLF legal department.
Justice Contacts the WLF
[The following October 5, 2004 letter was addressed to Mr. David Price, Senior Vice President, Legal Affairs, WLF.]
Dear Mr. Price: I am writing in response to your letters of April 16, 2004 and June 15, 2004, on behalf of the [WLF], in which you express concern about the [DOJ’s] criminal and civil investigations of the promotion by pharmaceutical companies of “off-label” uses of their products.
In your April 16 letter, you write that WLF is “concerned about recent press reports indicating that various United States Attorneys’ ofﬁces are conducting civil and criminal investigations of major pharmaceutical companies based, in part, on truthful and non-misleading speech about their products.”
While your letter included a copy of a “Counsel’s Advisory” by WLF’s Richard Samp, you did not include any of the press reports referred to in your letter. [First, let me point out that the Department does not have theoretical views regarding off-label promotion of products subject to regulation by the [FDA]. 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. Since we cannot discuss any matters that may or may not be under investigation, we are limited to discussing cases that have been completed.
As you know, on May 13, 2004, Warner-Lambert agreed to plead guilty and pay more than $430 million to resolve criminal charges and civil liabilities in connection with its Parke-Davis division’s illegal and fraudulent promotion of Neurontin. WarnerLambert agreed to plead guilty to two counts of violating the Federal Food, Drug, and Cosmetic Act (FDCA) by failing to provide adequate directions for use for Neurontin and by introducing into interstate commerce an unapproved new drug. The plea agreement between the United States and Warner-Lambert speciﬁ cally states that Warner-Lambert’s criminal conduct caused losses of $150 million and that the violations are felonies as a consequence of Warner-Lambert’s prior FDCA conviction.
Your conclusion, that recent developments and press reports “suggest a hostility on the part of the Department to off-label prescribing in general,” is mistaken. The Department’s position was most recently articulated by Associate Attorney General McCallum during a speech he gave at Princeton University in June to the Pharma, Biotech and Device Colloquium. As he noted, the Department 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. See United States ex. rel. Franklin v Parke-Davis, 147 F. Supp. 2d 39, 44 (D. Mass. 2001); cf. Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341,350 (2001) (analogous policy for medical devices); 21 U.S.C. § 396 (same). We agree that reprints of medical journal articles, reference textbooks, and independent continuing medical education can be beneﬁ cial to healthcare practitioners and their patients. The Department also recognizes that the First Amendment protects commercial speech, and that government regulation of the content of such speech is subject to intermediate scrutiny under Central Hudson Gas & Elec. Co. v. Public Service Comm’n, 447 U.S. 557 (1980).
The Department sees nothing inconsistent between these principles and the Neurontin investigation. That case involved false or misleading promotional claims about the safety and effectiveness of an FDA-regulated product and the provision and the provision of lavish gifts and other kickbacks intended to induce physicians to promote and to prescribe the drug for off-label uses. As you know, it is well-established that the First Amendment does not protect false or misleading commercial speech. As Mr. McCallum made clear in his speech, the Department must investigate and, where appropriate, prosecute the illegal marketing and promotion of off-label uses. The FDA Modernization Act, which amended the FDCA by adding a provision addressing manufacturer dissemination of treatment information on new uses of a drug or medical device (21 U.S.C. § 360aaa - 360aaa-6), 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 FDCA or the federal anti-kickback statue inapplicable to pharmaceutical manufacturers.
The Department works with FDA to ensure that our litigation positions are consistent with that agency’s interpretation of the FDCA as it applies to manufacturer dissemination of information relating to off-label uses. We understand that FDA is receiving comments on First Amendment issues and invite you to transmit your comments on this issue through that process.
Since the Department is not free to comment on matters under investigation, this letter will have to sufﬁ ce in lieu of the meeting you requested. We appreciate hearing WLF’s views and we will take them into consideration. Thank you for contacting us.
Sincerely, Peter D. Keisler Assistant Attorney General [U.S. Dep’t of Justice] cc: Mary Beth Buchanan (Director, Executive Ofﬁ ce for U.S. Attorneys)
WLF Writes Back
[The following October 19, 2004 letter was addressed to Mr. Peter D. Keisler, Assistant Attorney General, Civil Division, U.S. Department of Justice.]
Re: Dissemination of information by pharmaceutical companies regarding “off-label” uses of medications
Dear Mr. Keisler:
Thank you for your October 5 letter responding to our concerns about the Department’s investigations and prosecutions of drug makers predicated on truthful and non-misleading speech about “off-label” uses of their products.
I hope this will be the ﬁrst step in a productive dialogue on this subject. As the holder of a judgment against the [FDA] based on its earlier policies on off-label information, and having worked extensively in the areas of patients’ rights and free speech, the [WLF] is perhaps uniquely suited to help the Department understand the constitutional and policy concerns involved. Moreover, I believe numerous important issues are left unaddressed by your letter.
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. There is, as you know, a multi-volume [U.S.] Attorneys’ Manual—including its Part 9-44.000 on health care fraud—that sets out numerous prosecutorial policies to guide prosecutors and to inform the public. This is as it should be. We hope such guidance will be forthcoming with respect to off-label prescribing and speech about it.
Let me be speciﬁ c by offering an example of an issue that the Department could very usefully address either in the context of our correspondence or in a public statement and also in guidance to prosecutors. As noted in our June 15, 2004, letter, Assistant U.S. Attorney Thomas Kanwit is quoted in the May 21, 2004, issue of the trade journal Rx Compliance Report, as saying, “There is regulatory language to suggest that it [an off-label use] may be an intended use if the company is aware of the use”—i.e., that it is a criminal violation for a company to do nothing to stop off-label use of its products when it becomes aware of that use. Mr. Kanwit is also quoted as stating that a claim for Medicaid reimbursement can still be a “false claim” even when the off-label use is one listed in a recognized medical compendium.
Mr. Kanwit, of course, handled the May 13, 2004, plea agreement with Warner-Lambert Company. The above statements seem to represent just the kind of “pure analysis” that you say the Department does not engage in. They also seem to contradict your statement that the Department has accepted the various federal court decisions that protect both off-label use and speech about that use. Do the quoted expressions of Mr. Kanwit’s views also reﬂ ect the Department’s views? If not, are there mechanisms in place to assure that no investigations or prosecutions are brought on the basis of these theories?
I would like to ask, also, whether Justice’s Ofﬁ ce of Legal Counsel has rendered an opinion on the constitutionality of prosecutions based on the actions of third parties in response to the defendant’s truthful and non-misleading speech, especially where, as here, there are two levels of intervening actions by those third parties over which the defendant had no control: the physician’s decision to prescribe the drug and the pharmacist’s decision to submit the claim to Medicaid.
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.
You note the Department coordinates its litigation positions with the FDA. We will continue to raise our concerns with the FDA, as you suggest. But the [DOJ] has an independent duty to ensure that its litigation positions conform to constitutional requirements—hence our desire to continue this dialogue with Justice, the agency that is actually bringing the actions.
Very truly yours, Daniel J. Popeo, Chairman and General Counsel [WLF]
David Price, Senior Vice President, Legal Affairs [WLF]