Gross 7.24.06

that a drug approved for treat-ment of an adult could be usedto treat a child).
cutors have benefited from increases infunding, personnel and other resources at various federal agencies seeking to inves- tigate and deter health-care fraud, includ- Services and the Food and Drug Agency’s physicians, third-party buyers and insur- Compliance counsel for pharmaceutical Congress has participated, as well, by over the right to convey truthful and non- allocating substantial funds to help identi- involved in “off-label” promotion and label uses. It is important to understand that, for purposes of off-label promotion, corporation and in their outside law firms practices has resulted in criminal convic- cians are treated very differently. It is ille- dreds of millions of dollars which, in turn, mote off-label uses of prescription drugs, except under certain, limited exceptions, formal investigations. Both corporate law medical journals. By contrast, doctors are adding to their compliance departments to legally permitted to prescribe medications “Off-label” is a short-hand term for a were permitted to promote off-label uses, companies and, in particular, such compa- all drugs are safe and effective for their ately implement into their patients’ active nies’ off-label marketing. Federal prose- drug treatments without the usual regula- Gross is of counsel to the corporate prac- tice group at Sills Cummis Epstein & Gross of Newark. The views and opinions expressed in this article are those of the marketing and selling it. In particular, the author and do not necessarily reflect the This article is reprinted with permission from the JULY 24, 2006 issue of the New Jersey Law Journal. 2006 ALM Properties, Inc. Further duplication without permission is prohibited. All rights reserved.
Bextra (arthritis). In addition, it is estimat- Serono S.A. pled guilty to felony charges ed that physicians prescribe off-label treat- and paid $704 million related to its off- label marketing activities for Serostim, its alleged that Serono provided kickbacks to doctors and caused the submission of false claims for reimbursement under Medicaid. $36 million to settle off-label promotion tives to physicians to use a particular med- icine for an unapproved use, these days it is just as likely that prosecutors will inves- tigate the perks that such companies have government, Eli Lilly promoted Evista off- label to treat heart disease and breast can- uses that are outside of those set forth in grants, continuing medical education sem- the drug’s FDA-approved labeling. One of inars, lavish conferences, free samples and • Neurontin — In May 2004, Pfizer’s fees for writing medical journal articles. In Warner-Lambert unit pled guilty to felony involves the aspirin tablet. While the FDA such actions, prosecutors generally argue charges and paid $430 million related to its that these practices are fraudulent promo- years ago, most doctors began prescribing tion schemes that corrupt the information it as a means to prevent heart attacks — an process relied on by doctors in their med- kickbacks and fraudulent marketing activ- off-label use — a little more than 15 years ities, including paying doctors to attend ago and continue to prescribe it off-label put patients at risk. Prosecutors may also conferences and treating them to trips to argue that such schemes result in payment vacation resorts, planting company agents of false or fraudulent claims under the fed- label for many years to decrease the risk of death after a heart attack. The FDA subse- informed, impartial judgment of doctors.
representatives to sit in on patient visits Consequently, patients who receive a drug and paying writers and doctors to prepare additional use. Similarly, most people do no assurance that their doctors are exercis- approved to treat erectile problems.
Pharmaceuticals paid a total of $850 mil- Instead, the FDA initially approved it to treat chest pain, and only later approved it to treat erectile dysfunction, after substan- misleading statements made by, or induce- tial off-label use. The same is true with quently prescribed it off-label to delay the onset of AIDS in HIV-infected people. The U.S.C. §321 et seq., which prohibits distri- dures to make sure they clearly define off- label promotion and distinguish permissi- ble promotion activities from impermissi- which prohibits the giving or receiving of scribed off-label, is staggering. It is esti- “remuneration” in return for purchases, examine whether the company’s marketing orders, prescriptions, referrals or recom- prescriptions are written for off-label uses.
information, or suggest reliance, on off- U.S.C. §3729 et seq., which imposes lia- gram should be designed to identify, detect scriptions are written per year, nearly dou- makes, uses, or causes to be made or used, and discipline those who engage in unlaw- ble the amount five years earlier. Studies a false record or statement to get a false or ful off-label promotion. It is not sufficient used off-label at least 50 percent of the have the proper written policies and proce- tigations and prosecutions involving off- also “monitor” and enforce the company’s rosy), anti-psychotic medications such as codes, plans and policies relating to off- instilling a compliance “mind-set” in and also regularly test the internal con- must also train (and continually retrain) doctors, as to what is and is not permit-


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