Quality of the estimate. December, p. 47 - Health Care Compliance ...

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December 2011 38 CIAs: A look back to Editor’s note: Jamie L. Kendall is Senior Director of Compliance, Ethics & Legal Affairs with Compliance Implementation Services LLC in Media, Pennsylvania. Jamie may be contacted by e-mail at jamiekendall@cis-partners.com or by telephone at 484/445-7200. The government’s assertion under a variety of legal theories that a pharmaceutical company’s off-label marketing to a physician causes the physician to write an off-label prescription, which in turn causes a pharmacy to submit a false claim for payment to a federal health care program, requires several leaps of logic. Nevertheless, the government’s focus on certain pharmaceutical company activities often forms the factual predicates for an investigation. Today, many still believe that this focus remains heavily upon pharmaceutical sales and marketing efforts. However, as manufacturers continue to establish tighter controls over sales and marketing activities, government oversight and enforcement activities continue to rise. For better or worse, Corporate Integrity Agreements (CIAs) the future at OIG investigations By Jamie L. Kendall, Esq. resulting from related settlements are made public, and the place that the government now looks for evidence of corporate intent to promote off-label usage is Medical Affairs. Indeed, complaints filed against pharmaceutical companies resulting in CIAs demonstrate that the government does not distinguish in investigations between Medical Affairs and Sales departments, despite clear, formal delineations. A reason for this may be that although the sales representative is a drug company’s principal conduit between business planning and actual sales, the Medical Affairs department is a critical component of a drug company’s overall growth, including research, clinical development, and scientific reputation. This requires Medical Affairs’ employees to engage in a variety of health care professional (HCP) interactions. And despite the fact that certain off-label conduct is permissible, the line between prohibited offlabel promotion and permissible off-label education is murky, at best. However, pharmaceutical company CIA provisions, resulting from recent settlements Health Care Compliance Association • 888-580-8373 • www.hcca-info.org involving off-label allegations, are often very similar, quite detailed, and reveal a fair amount about practices the government finds most problematic. During off-label investigations, the government routinely looks for evidence of manufacturer payments to physicians for prescribing off-label uses of the company’s drug. Enforcement cases typically involve a manufacturer’s provision of a payment or perk to a physician. Historically, this evidence was discovered through company marketing materials and documentation related to sales representatives’ activities. Over the past several years however, the pendulum of focus appears to have shifted towards Medical Affairs activities, as documentation submitted to the government within the scope of an investigation involving allegations around commercial (sales and marketing) practices expose manufacturers to liability stemming from Medical Affairs. From the government’s perspective, documentation and information, such as strategic drug development plans (including new uses, publication plans, and disease state awareness “campaigns”) serve as an obvious place for evidence of corporate intent to promote off-label usage of a drug. The Warner-Lambert case is illustrative. 1 According to the government, in that case, internal business plans allegedly
showed that the company viewed its continuing medical education (CME) program as an effective promotional program for Neurontin’s off-label use. The government often scrutinizes companies that hire medical professionals to do what the companies perceive sales representatives cannot do under US Food and Drug Administration (FDA) guidance. In the Warner-Lambert case, for example, the medical liaisons from the Medical Affairs department allegedly “initiated off-label promotions by raising off-label subjects” and presented themselves to HCPs as scientific experts when, in fact, they were not. The government suggested that the medical liaisons had a deceptive air about them and allegedly succeeded in accessing physicians (whom sales representatives had been unable to access) because they gave the appearance of having a scientific background. Warner-Lambert ultimately pled guilty and agreed to pay more than $430 million, in addition to executing a CIA requiring largescale compliance efforts by the company. The CIA included the requirement that Warner-Lambert (now Pfizer, Inc.) implement policies and procedures that address sponsorship or funding of research or related activities (including clinical trials, market research, or authorship of articles and other publications) that are designed to ensure that company funding or sponsorship of such activities complies with all applicable regulations and requirements. 2 Additionally, the 2009 Pfizer CIA demonstrates the risks associated with medical liaisons being perceived as Sales field counterparts, as opposed to Medical Affairs staff, allegedly causing off-label HCP discussions to take place. Indeed, as part of its 2009 CIA, Pfizer agreed to apply provisions of its CIA to Medical Affairs personnel and their participation in HCP interactions at meetings or events and clarify their role at such events. 3 CIAs and government complaints have signaled a common focus on payments to physicians that allegedly occurred under the guise of traditional Medical Affairs educational activities. Some examples include grant program payments relating to “observational” patient studies, consulting arrangement fees, and advisory meeting expenses. 4 Further, although investigator-initiated (or, “investigator-sponsored”) clinical trial grant programs encourage physicians and clinical investigators to study drug company products and release their findings, the government may view them as kickbacks in exchange for referrals. Significantly, at least three pharmaceutical manufacturers (AstraZeneca, Novartis, and Allergan) currently operate under Health Care Compliance Association • 888-580-8373 • www.hcca-info.org CIA-mandated business policies related to investigator-initiated trials. Notably, all three company CIA’s use nearly the exact same language throughout the Investigator Sponsored Trial (IST) section, changing only the name of the company and the amount of days each company is given to complete their duties. All three CIAs require each manufacturer to enter into written agreements describing the scope of the clinical research or other work to be performed, the fees to be paid, and compliance obligations for the researchers. 5 Each CIA also requires researchers to be paid according to a centrally managed, pre-set rate structure that is determined through a company-conducted fair market value (FMV) analysis. Annual budget procedures must also be created that identify the scientific or business need for the researchers, how many will be required, the activities to be performed, and the projected cost of those activities. Compliance personnel are also encouraged to review the budgets to ensure that they are being used for legitimate means. CIAs also require a needs assessment to be completed prior to obtaining researchers. The needs assessment is to identify the business or scientific need for the information to be provided by Continued on page 42 December 2011 39
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Page 3 and 4: INSIDE 5 The rising tide: Recognizi
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Page 13 and 14: n Starting from Scratch o I just re
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Page 19 and 20: Social Networking John Falcetano Ed
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Page 73 and 74: New HCCA Members Alabama n Patricia
Page 75 and 76: What could you do with The Power of

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