Biopharma & Medical Device

Highlights

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Recognized in the 2017 U.S. News - Best Lawyers "Best Law Firms" rankings.

Overview

Verrill Dana’s Biopharma & Medical Device Group provides practical, solutions-oriented advice to a broad array of life sciences organizations. We help clients achieve their objectives in the context of complex, intertwined, and evolving regulatory, enforcement, and industry standards, and we do so in a highly responsive and cost effective manner. We collaborate with attorneys in the firm’s health care, corporate, intellectual property, litigation, and labor and employment groups as appropriate to serve clients’ broader legal needs.

We know that other law firms strive to do all these things too. So what sets Verrill Dana apart?

  • Our extensive and diverse experience as senior in-house counsel and on-site seconded attorneys at large industry and health care provider organizations means we understand what you want from your outside counsel colleagues. We are flexible and easy to integrate into your existing team. We can work alongside you, run with projects independently, fill gaps in your internal staffing, or provide support in any other way you need.
  • With a highly experienced group of legal practitioners who focus on clinical research, we can provide comprehensive solutions for your organization’s clinical research initiatives. Several of the attorneys in our Biopharma & Medical Device Group also practice in the firm’s Academic and Clinical Research Group, which provides counsel to academic medical centers, universities, and other research organizations on a wide range of issues affecting clinical research. We have the experience and perspective to maximize the effectiveness of your research collaborations.
  • Our highly experienced senior attorneys and our thoughtful staffing enable us to deliver highest quality legal work at competitive rates. We don’t create big teams for the sake of having teams. Most projects can be handled by one or two attorneys, who can seek consultations from Verrill Dana colleagues as appropriate.
  • Our pragmatic and actionable advice on unique and cutting-edge issues in areas like value-based pricing, use of mobile technologies and social media, and international collaborations keeps innovative projects moving forward, even when governing rules have not been fully developed and clear precedents do not exist.

Now that we have piqued your interest, please read on for some additional information about our representative matters and what we might do for your organization:

Commercial Operations

Attorneys in the Biopharma & Medical Device Group have extensive experience advising the commercial operations of various life sciences companies. A number of our attorneys have held positions as in-house counsel and on-site secondments as outside counsel. As a result, we have a strong understanding of the operation of these companies, which informs our focus on providing practical strategies and recommendations and cost-effective legal support. The group has particularly deep experience in the areas of market access, pricing, reimbursement and government price reporting, patient advocacy and support, advertising and promotion, pre-approval communications, application of privacy laws to company operations and contractual relationships, fraud and abuse compliance and government enforcement, and market research, including:

  • Structuring and negotiating pricing and services arrangements with specialty pharmacies, wholesalers, group purchasing organizations, and other trade partners;
  • Developing pricing strategies, including value and outcome-based, and negotiating agreements with health plans, pharmacy benefits managers, and health care providers;
  • Implementing comprehensive Patient Support Programs, including activities such as copay and free drug programs, “bridge” or “fast start” programs, nurse case management, reimbursement support, clinical trial transition, and injection training and other patient interactions;
  • Educating clients on FDA advertising and promotion regulations, guidance, and warning letters, and assisting product teams in reviewing advertising and promotion materials and field medical activities, for both drugs and devices;
  • Helping clients comply with federal and state transparency requirements, including under the federal Open Payments Program (also known as the Sunshine Act);
  • Counseling clients with respect to government price reporting requirements (e.g., Medicare ASP, Medicaid AMP and BP, 340B) and consequences for pricing proposals, including value-based pricing arrangements;
  • Advising on Medicare, Medicaid, and commercial payor coverage and reimbursement; and
  • Undertaking due diligence review of products under consideration for in-licensing or acquisition.

Research and Development

Verrill Dana’s Biopharma & Medical Device Group, and more broadly the firm’s Health Care Group, includes a core group of attorneys who focus their practices on the legal and bioethical issues raised in the conduct and oversight of biomedical and clinical research, spanning from bench research, to multi-site phase III clinical trials, to post-marketing studies. We regularly advise clients in the following areas in the research space:

  • Structuring and setting up domestic and international clinical trials, including advising on domestic and ex-U.S. regulatory issues, the development of template research agreements, and negotiating with foreign sites;
  • Identifying permissible ways to help sites advertise and recruit for clinical trials (both generally and specifically using social media) under FDA regulations and guidance;
  • Using mobile technologies and social media in the context of, or as part of, clinical trials;
  • Complying with U.S. and ex-U.S. data protection laws (such as HIPAA and HITECH, state privacy laws, and the EU Data Protection Directive and member states’ implementing laws);
  • Drafting and revising informed consent forms in relation to FDA regulations, applicable privacy laws, and industry best practices;
  • Implementing single or centralized IRB review for multi-site trials;
  • Creating and operating disease research registries and enabling secondary use of research data and biospecimens;
  • Responding to government or regulatory audits of research sponsors and investigators;
  • Complying with Medicare and Medicaid secondary payor laws;
  • Applying the federal Anti-Kickback Statute and other fraud and abuse laws to clinical research activities; and
  • Understanding U.S. and foreign prohibitions and disclosure requirements applicable to industry gifts and payments to researcher-clinicians.

Privacy and Security

Our Biopharma & Medical Device Group has particular depth of experience advising biopharma and device companies on issues related to data privacy and security, including analyzing and complying with U.S and ex-U.S. federal and state privacy laws and frameworks, developing and implementing data privacy and security policies, structuring data sharing arrangements with vendors and other business partners, and, when the unexpected occurs, responding to privacy breaches and making required notifications. In this respect, our team frequently counsels clients on compliance with U.S. Federal Trade Commission guidance, the former U.S.-EU Safe Harbor Privacy Principles and current EU-U.S. Privacy Shield Framework, the EU Data Protection Directive and EU member states’ implementing laws, other ex-U.S. privacy laws, HIPAA and HITECH (when relevant), and state privacy and breach laws. Our experience in this area includes, among other projects, advising clients on:

  • Certifying compliance with the EU-U.S. Privacy Shield Framework, including conducting self-assessments and drafting required policies and procedures;
  • Navigating the complex privacy and security aspects of research registries, patient health records, and health information systems;
  • Marketing, distribution, and licensing agreements for information technology and data; and
  • Investigating, responding to, and mitigating data security breaches, drafting breach notifications, and negotiating settlements with federal agencies.

Mobile Technology and Social Media

Life sciences companies are increasingly integrating mobile technologies and social media into commercial and R&D operations, from passive listening to collecting information on patient needs and physician practices, to applying mobile applications in the context of, or as part of, clinical trials, to launching a social media presence on platforms such as Facebook, Twitter, and LinkedIn for more active engagement with stakeholder communities. We understand the myriad regulatory requirements facing companies in the life sciences sector that impact their ability to use mobile technologies and social media in these ways and have deep experience helping our clients make informed business decisions in this area. In particular, we provide advice and guidance related to:

  • Developing social media policies and practices;
  • Using mobile technology and social media in the context of clinical trials;
  • Monitoring requirements for adverse events and discussion of off-label use;
  • Allocating responsibility for content of comments posted by third parties; and
  • Reviewing company-posted content for regulatory compliance and best practices.

Contacts

  • Partner
    T: (617) 274-2856