Biotechnology and pharmaceutical manufacturers must recognize, understand, and address a significant number of legal and regulatory requirements associated with the research, development, pricing, promotion, marketing, and selling of their respective services and products — domestically and internationally. Significant scrutiny on these industries from the public; federal, state, and international regulators; elected officials; and enforcement agencies continues. Therefore, entities operating in these industries must remain even more vigilant and knowledgeable about the legal and regulatory parameters affecting their companies in order to stay compliant and proactive in order to minimize risk.

Epstein Becker Green counsels companies and institutions operating in the different segments of biotechnology and pharmaceutical industries domestically and internationally. We provide comprehensive legal services relating to all aspects of the development of products; the U.S. Food and Drug Administration ("FDA") regulatory approval process; government and third-party reimbursement concerns; and post-approval marketing, commercialization, and compliance requirements. Firm attorneys publish and present extensively at leading industry events and work actively on behalf of firm clients to both educate and advocate federal and state government agencies and regulators on significant industry issues.

Services/Scope of Practice

Development of Life Science Products and FDA Regulatory Approval

  • Providing FDA counseling relating to clinical trial registries and databases, grant making procedures, relationships with physicians investigators, and research institutions
  • Developing and negotiating co-development; co-promotion; outsourcing; and other strategic research, development, and collaboration agreements
  • Providing FDA counseling relating to labeling and advertising claims

Government and Third-Party Reimbursement

  • Counseling on government pricing programs, including Medicaid Best Price, Average Sales Price, Competitive Acquisition Program, the Federal Supply Schedule, and the Public Health Service Act, and VA pricing issues
  • Providing counseling and strategic planning assistance regarding federal and state drug and device reimbursement programs
  • Advising on the processes and strategies for obtaining coverage, coding, and payment for drugs and devices by government and private payors
  • Providing regulatory counseling regarding product discount/rebate arrangements with distributors, GPOs, managed care organizations, long-term care facilities, physicians, institutions, specialty pharmaceutical suppliers, federal and state purchasers (including SPAPs and other state and federal pharmaceutical programs), and other purchasers
  • Providing antitrust counsel related to manufacturer pricing issues
  • Counseling on license agreements and co-promotional activities

Post-Approval Marketing, Commercialization, and Compliance

  • Providing all facets of fraud and abuse counseling to manufacturers and their direct and indirect customers and/or purchasers relating to sales programs, marketing initiatives, and other collaborative programs and relationships, including disease management, medication therapy management, coupons, samples and sample cards, reimbursement support, grants, and patient assistant programs
  • Providing advice relating to all aspects of health reform regulations including the Sunshine Act and state reporting laws
  • Supporting and counseling on manufacturer new product launches
  • Providing health regulatory counsel relating to distribution and fee-for-service arrangements with MCPs and consumers
  • Providing FDA counseling relating to promotional matters, non-promotional activities, CME activities, and good clinical and laboratory practices
  • Providing all facets of counsel regarding post-market clinical trial research programs and grant administration
  • Counseling on licensure and other accreditation standards
  • Providing HIPAA privacy and security counseling relating to manufacturing, research, and marketing issues

Investigations, Litigation, and Administrative Matters

  • Defending manufacturers in connection with false claim qui tam actions and other federal, state, and congressional health care fraud investigations and inquiries
  • Negotiating corporate integrity agreements ("CIA") with the OIG
  • Assisting with the implementation and monitoring of CIA compliance
  • Providing counsel regarding the submission of voluntary disclosures to the OIG and/or other relevant regulators
  • Defending manufacturers and their research partners in private actions related to clinical trial noncompliance and misconduct
  • Preparing and assisting manufacturers for appearances at FDA administrative hearings
  • Assisting manufacturers in responding to warning letters and notice-of-violation letters, and congressional inquiries

Corporate Compliance

  • Developing and implementing all aspects of corporate compliance programs for manufacturers and their direct and indirect customers
  • Conducting corporate effectiveness reviews/assessments of corporate compliance programs
  • Developing training programs on corporate compliance for marketing and sales forces
  • Assisting with the development of reporting systems and compliance monitoring and auditing priorities
  • Assisting manufacturers with gap assessments and Board assessments
  • Providing counsel in connection with internal compliance investigations
  • Developing clinical trial research corporate compliance programs for manufacturers, clinical research organizations, and site management organizations, including compliance with Good Clinical Practices, human subject protection compliance procedures, and procedures regarding investigator-initiated research
  • Developing research compliance programs addressing relationships with research sites, researchers, vendors, professional organizations, independent foundations, and other participants in the clinical research process

Policy and Legislation

  • Monitoring and analyzing pending federal and state legislation, rulemaking, regulations, and guidance
  • Providing assistance with the submission of comments in connection with pending legislation and proposed rules, regulations, and guidance
  • Assisting with the preparation of testimony in connection with pending legislation
  • Providing counsel regarding federal and state marketing, disclosure, sales, gift, compliance program, pricing, clinical trials, pedigree, and related reporting requirements
  • Providing legislative industry updates and analyses

Federal and State Transparency Reporting

Counseling clients on Federal and state reporting requirements, conduct gap assessments, correct compliance implementation deficiencies, address infrastructure and resource matters, implement aggregate spend reporting systems, draft policies, procedures and working instructions, train employees, vendors and health care professionals, respond to government agencies and proposed regulations, analyze preemption matters and inform clients of federal and state law developments

Client Successes

Assisting a large biotechnology and pharmaceutical company with various product launch activities; providing a comprehensive range of services including legal and pricing training, contract reviews, aggregate spend counsel, and fraud and abuse analyses