Sidley has broad experience devising risk mitigation measures focused on U.S. sales and marketing activities for FDA-regulated entities, particularly as to non-cash-pay products for which federal coverage and reimbursement create False Claims Act exposure. Our Food, Drug and Medical Device Regulatory practices offer clients bench depth and experience dedicated to this key risk area for biopharmaceutical and medical device clients in particular, although we also have a significant emphasis on regulatory risks associated with the marketing of cosmetic, dietary supplement, and conventional food products. Our experience includes, as well, compliance reviews and representation on behalf of diagnostics developers and clinical laboratories, medical software companies, and consumer product manufacturers whose products present complex borderline issues requiring thoughtful sales and marketing risk mitigation.
U.S. sales and marketing risk for FDA-regulated companies represents an area of continued concern. The regulatory and enforcement environment remains highly complex and shot through with ambiguity, even with respect to key terms and foundational legal requirements and prohibitions. Although regulatory authorities have a somewhat more nuanced perspective of the public health utility of manufacturer participation in scientific exchange and dissemination of emerging risk and off-label use information, prosecutors, state attorneys general, relators, and other stakeholders remain committed to rigorous enforcement of the “off-label promotion prohibition” and seek ever-increasing penalties from manufacturers. Although most major manufacturers have resolved their largest False Claims Act/off-label promotion investigations through the payment of ever-increasing settlements and adoption of increasingly comprehensive Corporate Integrity Agreements, there is ample evidence of continued Department of Justice interest in initiating new investigations using novel theories under the Federal Food, Drug, and Cosmetic Act.
We can assist clients seeking to mitigate U.S. sales and marketing risk by:
- Supporting manufacturers’ existing copy review processes through on-call legal analysis and secondments during launch preparation and other periods of heightened demand;
- Conducting internal reviews of manufacturers’ policies and procedures for the preparation and approval of promotional materials and marketing programs to assure compliance with applicable regulatory requirements and manage risk;
- Benchmarking client practices and policies and evaluate proposed claims and executions in the context of the broader competitive environment;
- Analyzing hotline calls and other reports of improper conduct under “reportable event” provisions of Corporate Integrity Agreements and assist clients in calibrating their reports to federal officials through rigorous and thoughtful assessment of pertinent statutory requirements and regulatory expectations;
- Developing strategies for FDA and OIG engagement with respect to sales and marketing proposals to mitigate risk up front and advert enforcement correspondence from regulators;
- Conducting pre- and post- acquisition assessments of sales and marketing risks to augment internal regulatory diligence processes and assure effective risk mitigation as newly acquired assets are re-launched; and
- Providing rigorous FDCA regulatory analysis to support the defense of off-label marketing investigations and OPDP and other regulatory actions such as Warning Letters by formulating defenses grounded in the specific regulatory prohibitions on misbranding and the new drug approval requirement in the Federal Food, Drug, and Cosmetic Act and in the complex web of FDA regulatory pronouncements defining permissible forms of manufacturer communication.