Overview
Sub-Sections: Kickbacks | Off-Label Marketing | Clinical Trial Fraud | GMP Fraud
Nolan & Auerbach, P.A. provides experienced pharmaceutical fraud attorneys for employees with knowledge of pharmaceutical kickbacks, pharmaceutical fraud, and pharmaceutical pricing fraud schemes under the qui tam provisions of the Federal False Claims Act. Our pharmaceutical fraud lawyers have helped our clients to receive Relator share awards in excess of 12 million dollars in these types of cases alone. This area of the Nolan & Auerbach, P.A. site provides information for pharmaceutical fraud whistleblowers.
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, P.A. 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 $4 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.
Kickbacks
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 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 were ostensibly compensation to physicians for agreeing to speak at a formal speaking engagement. In most instances, they were kickbacks for prescriptions, with the physician never speaking at any formal function. - Phony Grants
Approved by management, pharmaceutical sales representatives have been allowed by certain companies to give “grants” to physicians, physician groups and medical facilities ostensibly for an educational program or research program. They have actually been used to provide kickbacks to physicians and companies to do whatever they wanted with the money, in return for business. - Phony Unlimited Preceptorships
Preceptorships are ostensibly a teaching session in which a physician would teach the sales representatives certain technical aspects of his practice in exchange for a sum of money, say $500.00. If the preceptorships were used to induce the physicians to prescribe a drug product (rather than in exchange for teaching), the payment violates the Anti-kickback Statute. - 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 Meetings
These meetings are typically for the ostensible purpose of getting input/feedback from physicians on drug performance, how they treat disease states. During Advisory Board meetings, honoraria, lavish entertainment and expenses for physicians have been paid for by the pharmaceutical companies. - Offering Pharmaceutical Kickbacks to Physicians in the Form of Samples
Some pharmaceutical companies have encouraged and facilitated the widespread provision of free vials of injectable drugs to physicians. How much the physician is given depends upon what the sales representatives negotiate. It is attractive to the physicians because each vial provided as a “free sample” is worth from $100.00 to $1,000.00 in revenue. Due to this inducement, the physician then determines that it would be quite profitable to start treating his patients with the injectable drug that he profits most on.
Off-label Marketing
Off-label whistleblowers have caused several pharmaceutical companies to modify their illegal promotions where the FDA has not. Nolan & Auerbach, P.A. 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 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 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 results interpretation this is a case of pharmaceutical fraud. Nolan & Auerbach, P.A. pharmaceutical fraud attorneys are currently representing whistleblowers in sealed qui tam cases involving drugs that were approved by the FDA based upon fraudulent manipulation of clinical trial data – clinical trial fraud.
GMP Fraud
A corollary of clinical trial fraud are violations of the current Good Manufacturing Practices. 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 regulations.
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. For more information on Good Manufacturing Practice Regulations click here.
Nolan & Auerbach, P.A. provides experienced legal representation to individuals with knowledge of pharmaceutical kickbacks or other pharmaceutical fraud under the qui tam provisions of the False Claims Act, representing whistleblowers who have information about pharmaceutical fraud (including clinical trial fraud, GMP fraud, NDA fraud, pharmaceutical kickbacks, off-label), and pharmaceutical pricing fraud (average sales price fraud, Medicaid rebate fraud, best price fraud, and so on).
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