The purpose of the qui tam provisions of the False Claims Act is to encourage private individuals who are aware of pharmaceutical off-label marketing fraud, pharmaceutical kickbacks, pharmaceutical pricing fraud, and other fraudulent activities being perpetrated against the government to bring such information forward. Nolan Auerbach pharmaceutical fraud attorneys have broad experience in preparing, investigating, and prosecuting False Claims Act cases involving, inter alia, drug company kickbacks, pharmaceutical pricing schemes, false average sales price cases, and off-label whistleblower cases.
In increasing numbers, pharmaceutical fraud whistleblowers have come out of the woodwork to expose pharmaceutical fraud. Several hundred pharmaceutical fraud cases covering more than 500 drugs are now under investigation by the U.S. Department of Justice under the False Claims Act. Settlement of the first 16 pharmaceutical fraud cases (including kickbacks, Medicaid rebate fraud, and best price violations) brought by whistleblowers has returned over $10 billion to the U.S. On the radar screen in addition to pricing schemes, off-label marketing fraud and pharmaceutical kickbacks, are NDA fraud, GMP fraud, clinical trial fraud, average sales price fraud, Medicaid rebate fraud, and a variety of other fraudulent schemes exposed by pharmaceutical fraud whistleblowers.
Federal law prohibits pharmaceutical kickback fraud because it is thought to color the judgment of the physician, i.e. the physician will prescribe a prescription drug based not on what is best for the patient, but based upon what prescription drug product most increases the physician’s bottom line. This is bad for the patient and bad for Medicare, Medicaid and other Government healthcare programs. Other examples of kickbacks are as follows:
- Offering Pharmaceutical Kickbacks to Physicians in the Form of Phony Drug Studies
Some pharmaceutical companies have provided remuneration for post-marketing clinical studies as a means to induce physicians to prescribe their products. The “research” performed has no legitimate value, and is merely a pretext for payments for referrals.
- “Phony Speaker fees” paid for by Honoraria
Some pharmaceutical companies have used “honorarium” fees or “speaker” fees for physician marketing. Approved by management, they are ostensibly compensation to physicians for agreeing to speak at a true educational event.
- Phony Grants
Approved by management, pharmaceutical sales representatives have been allowed by certain companies to give “grants” to physicians, physician groups and other healthcare providers, ostensibly for an educational program or research program.
- Phony Investigator Meetings
In some pharmaceutical companies, investigator meetings are ostensibly called for physicians to talk about potential non-indicated uses of drugs. Sales representatives are allowed and instructed to spend lavishly on all physicians, both the speakers and invitees. It has been typical for investigator meetings to last only two hours, yet pharmaceutical companies paid for the physicians’ airfare, hotel, golf, spa treatments, etc. at luxury hotels around the country.
- Advisory Board and other Meetings
These meetings are typically for the ostensible purpose of getting input/feedback from physicians on drug performance, how they treat disease states, etc. During Advisory Board meetings, honoraria, lavish entertainment and expenses for physicians are paid for by the pharmaceutical companies.
Nolan Auerbach pharmaceutical fraud lawyers have extensive experience in this area of the law, but we are very selective. We believe that an off-label marketing case is worth pursuing only if there is some type of efficacy issue and/or patient harm resulting from the illegal off-label promotion. Our pharmaceutical fraud lawyers have been very successful with this approach. For more information on off-label marketing, click here.
Clinical Trial Fraud
Clinical trials sponsored by pharmaceutical companies (“pharma”) may not always produce the same results as those conducted by the government and other public entities. For example, in an analysis published in the American Journal of Psychiatry, it was found that in every publicly available trial funded by pharma that compared five new antipsychotic drugs against each other, the results of 9 out of 10 studies concluded that the best drug was the one manufactured by the pharmaceutical company sponsoring the study. The article suggests that such divergent results can be the result of biases in trial design and even in interpreting the study outcome. Experts say that this situation is even more prevalent in trials that measure symptomatic relief as opposed to whether or not a disease was actually cured, as such trials lend themselves to less stringent interpretation. Nolan Auerbach pharmaceutical fraud attorneys represent whistleblowers in qui tam cases involving drugs that were approved by the FDA based upon fraudulent manipulation of clinical trial data – clinical trial fraud.
GMP fraud is a practice that also frustrates the scientific process and jeopardizes the integrity of the drug product. “GMP” fraud is the acronym for the Current Good Manufacturing Practice Guidelines.
The GMP regulations stem from Congressional concern over the danger that impure and otherwise adulterated drugs might escape detection under a system predicated only on seizure of drugs shown to be in fact adulterated. That is, Congress desired to require manufacturers to abide by laws that, if complied with during the manufacturing stage, would theoretically prevent pharmaceuticals from contamination, bioavailability, or potency defects, for example. The GMPs require manufacturers to have adequately equipped manufacturing facilities, adequately trained personnel, stringent control over the manufacturing process appropriate laboratory controls, complete and accurate records, reports, appropriate finished product examination, and so on. Certain violations of the Good Manufacturing Practice Regulations may be the basis for a False Claims Act lawsuit.
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- CGMP Violations – describes violations of the Current Good Manufacturing Practices promulgated by the FDA.
- Off-Label Marketing – describes off-label marketing in general.
- Best Price Fraud – a quick trigger questionnaire to determine if Best Price Fraud has occurred.
- CME Fraud – describes the use of Continuing Medical Education by pharmaceutical companies as a means to improperly influence and induce physicians to prescribe their products.
- Unapproved Drugs – describes the Drug Efficacy Study Implementation Program.
- Long Term Care Pharmacy Fraud – describes how pharmaceuticals are adulterated or repackaged in violation of the False Claims Act.
- Pharmacy Benefit Manager’s Fraud – describes how the relationship between pharmaceutical companies and PBMs may violates the False Claims Act.