Attorneys in Verrill Dana’s Health Care Group have extensive experience advising companies in the life sciences industry, including pharmaceutical, biotechnology, and medical device companies. We appreciate the intricacies of operating in a regulated environment and the particular challenges that arise in keeping up with and responding to developments in the regulatory landscape. Our experience in this area complements the work we do for many clients in the health care industry with respect to clinical trials, reimbursement, and other regulatory issues. Where necessary to provide complete and cost-effective advice in a particular matter, we work with attorneys in the firm’s corporate, intellectual property/patent, litigation, and labor and employment groups.
We counsel life sciences companies on a wide range of issues, including:
Research – Our attorneys advise both research sponsors and institutions on a variety of contractual, regulatory, and compliance issue. We have assisted organizations with internal investigations related to alleged violations of federal regulations or institutional policies. Our experience in this area includes issues related to:
- Informed consent
- Disease registries as research
- Clinical trial agreements
- Conflicts of interest
- Human subjects research regulations
- HIPAA and state privacy laws
- NIH/ORI requirements
- Research misconduct
- Development and operation of data and biological specimen research repositories, including secondary use
- Interactions with institutional review boards (IRBs)
- Materials transfer arrangements
- Clinical trial transparency reporting (both federal and State of Maine)
Compliance – Verrill Dana’s Health Care Group works with in-house counsel on all matters related to FDA compliance. Our attorneys assist pharmaceutical and biotechnology companies in the development and ongoing assessment of their compliance programs, as well as in revising policies and procedures to be in accord with FDA rules and regulations and the PhRMA code. We counsel clients on the full spectrum of issues that arise under a compliance program, including:
- Post-approval advertising and promotion
- Scientific exchange
- PhRMA code issues (e.g., speakers programs and advisory board meetings)
- Research grants
- Responding to compliance hotline complaints
- Conducting internal investigations
- Responding to government investigations and counseling on potential enforcement actions
- Negotiating settlements
- Measuring compliance with CIA requirements
Regulatory – Our attorneys advise on all other federal and state laws that may affect life sciences companies, including:
- FDA regulations
- Health care privacy
- Data security, including cross-border transfers
- Health care regulatory matters, including fraud and abuse
- Distribution
- Antitrust
- Intellectual property, including patent prosecution and litigation
Social Media – Pharmaceutical and biotechnology companies are increasingly involved in social media, from passive listening to collect information on patient needs and physician practices to development of branded and disease-focused websites for more active engagement. We understand the myriad of regulatory requirements facing companies in the pharmaceutical/life sciences sector that impact their ability to engage in social media and help clients make informed business decisions in the absence of substantive FDA guidance. We provide advice on:
- Development of social media policies
- Use of social media in the context of clinical trial enrollment
- Monitoring requirements for adverse events and discussion of off-label use
- Crisis response
- Review of content for regulatory compliance
