According to the Rx Compliance Report, “federal prosecutors are reporting that the pace of new qui tam filings (whistle blower cases for pharmaceutical and device companies) has slowed considerably and the alleged illegalities cited in new suits are less egregious than in years past.”
According to leading qui tam attorney Robert M. Thomas, Jr., “we are seeing people driving 67 in the middle lane as opposed to 92 in the fast lane,” which is making their “job harder.”
One reason for this slowing is due to pharma companies working to stop the steady flow of qui tam suits alleging drug marketing fraud over the past decade, and according “to several federal prosecutors, these efforts are now paying off. The slowing however does not unclog the “pipeline of cases, which remain badly backlogged,” nor does it erase the
“blockbuster settlements for activity in years past, which continue to fuel the perception among many in Congress and the mainstream media that nothing has changed.” These factors “continue to drive increased discussion at both the Justice Department and the OIG about ever stronger deterrents, including individual prosecutions and mandatory divestiture.”
Despite these factors, and what some claim as “plenty of off-label activity” in the newly filed cases, “there is also “a qualitative difference” in terms of the conduct that is described,” according to qui tam attorney Brian Kenney, who represented relators (whistle blowers) including Pfizer’s $2.3 billion Bextra settlement.
Whereas before, Kenney’s experience found entire divisions dedicated to off-label marketing or in-house training manuals discussing the criteria for how to market off-label, he now says this “type of egregious conduct is no longer evident.” In fact, he asserted that now there has been a downtick in how outrageous the off-label marketing and kickbacks have been in terms of payments, and the “river of money” flowing to physicians” has been staunched.”
The difference Kenny is seeing now in more recent cases is that they “focus more heavily on issues such as falsity, where the off-label marketing is accompanied by falsity as to the efficacy of the drug or specific falsities as to the side effects of the drug.” While he believes this shift calls into question a lot of “the scientific studies that are being used and the accuracy of some of those studies,” he also noted that “the evidence of off-label marketing is not as strong as it used to be.”
What has also led to less evidence and cases is that “in the wake of a steady stream of settlements, companies have established sophisticated compliance programs,” although smaller companies have had a more difficult time implementing changes because of costs needed to set up a whole compliance team that is deeply immersed in these issues.” Still, the government is largely focused on “off-label plus” cases, which means looking for off-label promotion, plus an aggravating factor such as kickbacks, false statements, patient harm, or serious risk to patients. But because the evidence is lacking now and not as strong, Thomas noted that “if it’s a borderline off-label case, that is going to be a tough sell.”
Thomas also discussed “compendia issues, which are present in all off-label cases, and remain a paramount consideration.” He explained that “when a drug is approved for a certain use, it often may have efficacy for other uses that are not approved, however, reimbursement for these off-label uses depends on whether there is support for these uses in research compendia.” As a result, Thomas noted that in a lot of our off-label cases, “before or even during the period that the matter is under investigation, companies are continuing to do research and pay doctors to do clinical studies and write papers that will show – or hope to show – efficacy for some of these unapproved uses.”
Since companies are carrying out this research, “it takes the sting out of a prosecution,” because if patients really need the drug, it creates a “no harm, no foul” situation even if the FDA has not given it the stamp of approval.” According to Thomas, this “relationship between the research community and these databases is having a major impact on how off-label cases are brought.” The problem he sees with this relationship is that some of the research is being funded by the drug companies themselves, which can cause the government to pay for more uses of the drugs than it should, and it inserts a level of ambiguity into the analysis of potential off-label prosecutions.”
For Sara Bloom, an Assistant U.S. Attorney in the U.S. Attorney’s Office in Boston who has played a leading role in several major drug marketing investigations, “off-label cases are now becoming “less simple” in some respects.” To that effect, she explained that in the past, showing a drug was promoted for uses it was not approved for has become something totally different today, in which dosages and comparative claims now come into play.
This complexity has led the DOJ to give “serious thought” about what type of remedy might be required to prevent future violations, according to Bloom. One consideration being discussed is “whether, and to what extent, the government will use the Responsible Corporate Official Doctrine, which says that anyone in a position of responsibility can be liable under the government’s misdemeanor authority even if they lack specific knowledge of the violations in question.” Other potential remedies could include divestiture of specific products or giving up generic exclusivity in order for the OIG to waive its permissive exclusion authority.
Accordingly, “one thing that has not changed in recent years is the length of time most pharma qui tam suits take to settle.” As David Haron, who heads the Qui Tam Practice at Frank, Haron, Weiner & Navarro in Troy, MI, explained, “off-label cases are especially time-consuming for several reasons.” Haron explained that cases are nationwide, covering billion dollar drugs produced by multiple-billion dollar multi-national companies with sometimes millions of claims all over the country that have to be assembled, sampled, and evaluated. This creates the need to interview witnesses and conclusions to be reached while the case is still under seal, as well as physicians who were targeted by employed sales reps. Additionally, massive amounts of information and claims and the numerous individual Medicaid State agencies involved further complicate investigations.
Conclusion
While Americans should be pleased with the fact that companies are beginning to comply with new rules and programs regarding off-label promotion, consumers must also not forget that “off-label prescribing is an integral part of the practice of medicine,” as veteran attorney Stephen Immelt of Hogan Lovells in Washington, D.C. points out.
Since off-label prescribing is sometimes the standard of care, “defending off label cases takes the perspective of patient harm versus patient benefit.” Immelt explained that other issues to consider are “whether physicians or the FDA have been misled in any serious way.”
Defending off-label prescribing is particularly important in certain areas such as oncology, where oncologists tell us that the best and current standard of care often does not track the FDA approval process.” This would mean that “if oncologists were forced to wait for that process to unfold, it would have a deleterious impact on patients.” While there is no question that everyone deserves there day in court when justified, preventing others from treatment by slowing the FDA approval process through litigation will cause more harm than benefits to patients.