Off-Label Dissemination: What the Constitution Giveth, Are the OIG and DOJ Taking Away?

  • Published on: January 1, 2004
  • Category: FDA News

Although this may be an unusual format for expressing legal and political views, it seems appropriate to address this communiqué—call it an open letter—to each of you in a public forum. This "letter" is not intended to be a law review-like dissertation; rather it is an honest and candid assessment of where industry feels it is today, given your recent prosecutions in, among others, the TAP, AstraZeneca, Abbott, Schering-Plough, and Guidant cases.1

While we do not condone some of the activity cited in those cases, some of the legal theories espoused trouble industry because they seem to have an intended application far beyond those cases. It as if the Office of Inspector General (OIG) and the Department of Justice (DOJ) are expressing politically their institutional distaste both for off-label prescribing and for the otherwise constitutionally-protected activity of off-label dissemination as contemplated by Judge Lamberth in the Washington Legal Foundation (WLF) case.2

Hopefully, this letter will provoke some introspective thinking, if not for the prosecutors addressed, then at least for the judiciary and those legislators or administration officials who might be able to keep prosecutors from legislating through prosecutions. We, in the regulated community, object to the increasing "creativity" used by federal and state prosecutors to contort existing statutes to meet the immediate needs of the prosecutor in a particular case. Many times these expanded and an untested novel theory, proffered by an earnest prosecutor, into judicial precedent, which will then result in jail time for an executive.

Think of this letter like the one sent to the newspaper by the innocent little Virginia, asking if Santa is real. Virginia wanted to believe that what she grew up believing was, in fact, true. Similarly, the healthcare industry wants to believe the U.S. Constitution is real, that it actually protects commercial speech from government incursion, and that legislating will be left to Congress and state legislatures, and regulating to administrative agencies. While the healthcare industry is not quite as innocent as Virginia, the consequences of these prosecutions are more severe—jail time and enormous civil and criminal fines—than Virginia’s potential disillusionment.

Industry wants certainty in regulatory behavior. Momentous shifts in the law should not be the result of theories intro- duced in a criminal or civil prosecution. While many of the current cases do involve questionable conduct, or even conduct that may be illegal under other statutes, that conduct alone does not justify creative expansion of the law. And, even though it is politically popular and expedient to prosecute pharmaceutical and medical device companies, our federal prosecutors must remember that behind all of these cases are real people with families and normal lives. Exercise prosecutorial restraint, behave ethically in creating and bringing cases—as you expect those in industry to behave—, but do not invent new law in doing so. And please do not revel from the podium and elsewhere, as these newly-invented theories are unveiled.

Recent prosecutions under the False Claims Act (FCA) argue that a manufacturer is responsible for "causing" a health- care provider to submit a claim for reimbursement of off-label uses. This theory is not only new and novel, it is downright scary in light of the fact that a large percentage of pharmaceutical and medical device products prescribed today are for off-label uses—regardless of whether the manufacturer is involved. This prosecutorial position sends mixed signals when, in other contexts, the government supports off-label prescribing in the practice of medicine and the dissemination of off-la- bel information, which actions often result in medical advances. These prosecutions will stifle the kind of discovery—good discovery—that benefits patients, and will stifle the legitimate exchange of medical and scientific information that fuels those discoveries.

"We’ve come a long way, baby," to coin a phrase, with FDA on the free speech front. Many advances were made follow- ing the landmark WLF cases—manufacturers, physicians, and patients presumably regained Constitutional freedoms through
and Constitutional protections? In other words, what the Constitution giveth, will the OIG and DOJ taketh away?

The OIG and DOJ have tied off-label uses of products to liability under the FCA and the Anti-Kickback Statute, not only for physicians, but also for manufacturers. The theory, simply stated, is that if a product is prescribed off-label by a physician who then seeks reimbursement for a use not found in the label, the submission of such a claim may be a false claim for reimburse- ment for which the physician may be civilly and/or criminally prosecuted. The manufacturer may be liable also if it "causes"
or induces the off-label use or is the product of a kickback-laden relationship and, in either case, a subsequent false claim for reimbursement is made. The OIG/DOJ theory in the Pfizer Neurontin case is that "the claims were fraudulent because they were the intended end-result of Defendants’ unlawful and fraudulent off-label, kickback-laden marketing scheme."3

Sound the warning bell for both healthcare providers and manufacturers! Government has found yet another way to punish the practice of medicine and the appropriate and lawful exchange of scientific information. Given the enormity of off- label usage of drugs, biologics, and medical devices in this country, managed care organizations, hospitals, clinics, individual physicians, and manufacturers and their employees should stand-up and take note of this sweeping and alarming view of off-label prescribing.
It is troubling that the OIG/DOJ’s prosecutorial efforts run counter to other instances of governmentally-expressed intent to allow for the off-label use and dissemination of information. The following are instances where appropriate off-label dis- semination is permitted:

  • (1) Congressionally-expressed intent as manifested in section 401 of the Food and Drug Administration Modernization Act (FDAMA);4
  • (2) judicially-expressed intent in the WLF, Pearson, Western States, and Whitaker cases;5
  • (3) administratively-expressed intent in FDA guidance documents discussing off-label use in the "practice of medicine"
  • (admittedly FDA’s support is for off-label prescribing, not necessarily off-label dissemination);6 and
  • (4) administratively-expressed intent in guidance set forth by the Center for Medicare & Medicaid Services (CMS) to encourage the reimbursement of medically-necessary off-label uses.7


Despite this societal expression of support for allowing off-label uses by physicians, the OIG and DOJ have "legislated" new rules through prosecution. What one arm of the government was unsuccessful in stopping directly, another arm is at- tempting to stop through indirect means. Where FDA was unable to prohibit off-label dissemination because of its encroach- ment upon the Constitution, the OIG and DOJ are attempting to prohibit through creative application of the FCA.

This whole prosecutorial trend is troubling on many fronts. First, it is scary to be in a regulated company today. The state of the law is unclear—evolving through unpredictable volcanic eruptions—as the OIG and DOJ announce radical interpre- tations of the law in theories such as those espoused in the "AWP spread" and "disgorgement" cases. Next in line are the newly-announced FCA cases using "HIPAA" as the predicate statute.

Second, the interpretations are void for vagueness. Government should not be allowed to criminally prosecute cases where the understanding of the prosecutorial theory takes a good lawyer, much less an average citizen, through a labyrinth of analysis. It is a tortuous path to understand how off-label dissemination results in a manufacturer’s complicity in a false claim for reimbursement.

Third, as stated above, there is a fundamental due process issue when government starts legislating by way of prosecution.

Finally, and of the most concern, is the misuse of prosecutorial discretion. It simply is inappropriate to use the word "cre- ative" to describe criminal indictments. Prosecutors should not be that cavalier in their use of the law when people’s lives are at stake. The law needs to be predictable and if prosecutors do not have enough tools or theories at their disposal, they need to go back to the legislative bodies to ask for more, rather than dispensing with the democratic process and creating powers/ theories as a political expedient to their ends.


Mark E. DuVal, Esq.
Klepinski & DuVal, P.A. Minneapolis, MN

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