I have rarely found myself in a position where my family and professional career intersects. Before one reads further, this is not a salacious story about defending a family member or advising them on an investigation, but simply a learning for professionals at the dinner table.
I have two research scientists in the family, one an immunologist and one on the way to becoming one. One in academia still, and another in Pharma. You can imagine that when Sunday dinner rolls around, the rest of us usually are either trying to keep up or feigning some understanding of the protein make up of something or how this receptor binds to react with something to create some reaction seen at the molecular level. It is not that I don't share in their deeply committed passion for research in their respective areas, it's that my side of the brain was not as active in Organic Chemistry and Molecular Biology.
Recently however, the conversation drifted to a discussion on a topic that was interesting from both of our points of view and one that I could contribute to without a copy of my trusty International Pharmacopoeia and Molecular Biology texts.
There was a question regarding Off-Label usage of a particular drug and why this company made such a big deal about teaching new principal investigators on ethics and accountability (great job in my opinion). Both scientists were questioning why the company was so concerned with Off-Label usage since it was the physician's ultimate responsibility to prescribe a particular drug or treatment.
Since the two scientists in the family rarely wandered into the compliance territory, I felt it necessary to jump in and add my two cents. For once, I could hold my own without the help of the internet and medical texts, and I had a chance to "enlighten" them.
Recent cases suggested, at first glance, that the Food and Drug Administration was losing interest in prosecuting Off-Label Promotions criminally. The Federal Food, Drug and Cosmetic Act (FDCA) had been interpreted in some circuits to no longer prohibit "truthful, non-misleading speech" that could be interpreted to promote Off-Label usage of prescription drugs.1 In fact, the case interpretation was broadened in the Southern District of New York even further. Here the court stated that the FDA may not bring an action based on "truthful promotional speech alone".2 The Off-Label promotion theory of prosecution was bombarded by court skepticism in other cases as well.
The realty of the matter is however, that the Government continues to prosecute cases under alternative methods such as the False Claims Act when the Government can determine it can clearly demonstrate the distinction between "marketing a drug for a purpose obviously not contemplated by the label and marketing a drug for its FDA approved purpose to a patient population that is neither specified nor excluded in the label".3
In False Claims Actions, the Government usually focuses on cases that are clearly outside the scope of the FDA approved label process. Evidence should also exist that management had knowledge of the promotions demonstrating Off-Label promotional activity, that there was evidence of specific actions by the pharmaceutical company that they compromised the objectivity of the physician's prescribing habits, and probably most important, there was indicia that the off-label use posed a significant threat of patient harm through adverse side effects or ineffective treatment. In other cases State Attorneys General have brought matters where companies ignored risks to certain patient populations or misrepresented the impact of scientific studies.4
The proofs that are required in Off-Label prosecutions often are statistical in nature and are not obvious at first. However, when gathered through analysis, the proofs become painfully obvious. It is for primarily that reason that prevention and education are the strongest tools not only to avoid an issue all together but to provide a strong defense should one become necessary.
The reality of the matter is that both federal and state enforcement actions, while not specifically directed at off-label usage, will continue and promotional practices in general, especially those that could be construed to be false or misleading will be aggressively pursued. These investigations can be costly whether or not it leads to civil or criminal prosecutions. An ounce of prevention is worth a pound of cure, and anyone charged with the enforcement and analysis of the cost of a corporate integrity agreement can attest to that statement.
My advice to the scientists in the family was simple, pay attention to the true objective of the research, do good things, be truthful in all statements, and listen to the compliance folks, we are here to help.
Our firm has assisted in gap analyses on control practices in healthcare for outside monitoring and provided analytical modeling to assist in risk identification for pharmacies to assist in integrity and quality processes.
In the words of Chief Judge Easterbrook, "The lower the rate of a fraud's detection, the higher the multiplier required to ensure that crime does not pay."5 In plain words, the longer it takes to solve the case, the more the cost of the fine. Off-Label cases often involve huge fines and while the legal atmosphere seems unsettled, the compliance initiative seems clear. Training, monitoring, and sensible analytics are investments worthy of continuing.
4. Press Release 16-653, U.S. Department of Justice Office of Pub. Affairs, Pharmaceutical Companies to Pay $67 Million to Resolve False Claims Act Relating to Tarceva (June 6, 2016) https://www.justice.gov/opa/pr/pharmaceutical-companies-pay-67-million-resolve-false-claims-act-allegations-relating-tarceva
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