As the regulatory, legal, and business environment evolves, Epstein Becker Green crafts guidance that balances in-depth regulatory analysis and each health care product manufacturer's business objectives.
Innovation in medical devices is necessary but not sufficient to ensure a successful market entry. Manufacturers often walk a fine line between conveying the market value of their goods and abiding by the myriad laws governing the promotion of drugs, biologics, and medical devices. Manufacturers have to navigate the marketplace while complying with a more complex regulatory landscape: the FDA's increased focus on enforcement of promotional requirements, the threat of larger fines for off-label promotion, and emerging new challenges presented by social media as a mainstream marketing vehicle.
Restrictions on the promotion of regulated pharmaceuticals, devices, and biological products are evolving as new laws are passed, new cases are tested in the courts, new government settlements take place, and industry codes of conduct are developed and updated. We counsel clients on managing the risk of fraud and abuse, as these rules continue to develop, and also assist manufacturers in establishing Good Promotional Practices ("GPPs") for their products.
Services/Scope of Practice
Epstein Becker Green provides complete legal support for health care product manufacturers in connection with their sales and marketing activities. We help these manufacturers evaluate compliance risks and take steps to reduce those risks and protect their interests. Epstein Becker Green takes a pragmatic approach to assisting clients with product promotion needs, taking into account their product, the marketplace, and a client's risk tolerance. Our services include:
Assessment — Helping clients understand relevant laws and their potential exposures, including as due diligence counsel:
- Developing strategic legal plans for the acquisition of health care and life sciences industry entities
- Providing advice and counsel regarding the compliance risks associated with promotional and non-promotional (e.g., scientific) product, company, and disease state communications
- Conducting Prescription Drug Marketing Act and Drug Enforcement Administration compliance reviews
- Conducting due diligence reviews for buyers and sellers of health care companies
- Conducting effectiveness reviews of compliance with state pharmaceutical marketing restrictions and reporting requirements
- Preparing and conducting health regulatory reviews of various securities filings
Prevention — Developing compliance programs, procedures, and policies and training employees, which includes:
- Conducting corporate compliance effectiveness reviews
- Developing and revising manufacturers' GPPs and policies
- Providing real-time training for sales teams and marketing experts on regulatory compliance and GPPs
- Drafting consulting, speaker, research, and other services agreements related to clients' promotional activities
- Reviewing existing and new marketing and promotional materials and strategies, including the analysis of promotional claims and strategies relating to the use of social media and mobile applications, for a wide variety of clients (e.g., medical device, clinical laboratory, human tissue, pharmaceutical, diagnostic, and other areas)
- Assisting in promotional strategy and claims analyses
- Developing systems for tracking and reporting financial relationships with health care providers to federal and state governments
- Providing advice and counsel regarding state pharmaceutical and medical device marketing laws and reporting requirements
Protection — Protecting clients' interests against threats of investigations, prosecution, and lawsuits, which includes:
- Representing clients in litigation related to fraud and abuse laws, such as false claims, qui tam cases, unfair trade practices, and other possible enforcement activities
- Counseling clients on how off-label use and promotion can raise issue under the False Claims Act and related state laws
- Initiating, or defending, lawsuits concerning advertising, substantiation, and unfair competition claims related to health care products
- Preparing trade complaints regarding competitor promotional claims and activities that threaten the client's interests
- Representing clients that are the subject of preliminary inquiries and formal government investigations
- Assisting clients in responding to warning and untitled letters and other government communications related to their promotional activities
- Assisting clients in sending, or responding to, cease and desist letters related to advertising of medical devices and other health care products and services
- On behalf of individual companies and trade associations, Epstein Becker Green attorneys helped ensure that health care economic information was appropriately shared while maintaining compliance with FDA requirements.
- For a large, global medical device company, we reviewed its current use of health economic and reimbursement information in promotional materials, drafted policies to ensure the appropriate use of this information, and trained the company's personnel on the regulatory framework governing the use of the information.
- Epstein Becker Green attorneys helped a large medical device manufacturer develop and successfully implement a comprehensive system of GPPs that achieved both compliance and the manufacturer's marketing objectives.
- We have helped many companies successfully respond to FDA Warning Letters challenging their promotional activities and represented such clients in meetings with FDA and other federal agencies to discuss these matters.