Pharmaceuticals

Overview

Biotechnology and pharmaceutical manufacturers must recognize, understand, and address many legal and regulatory requirements associated with the research, development, pricing, promotion, marketing, and selling of their respective services and products—domestically and internationally.

The biotechnology and pharmaceutical industries continue to receive significant scrutiny from the public; federal, state, and international regulators; elected officials; and enforcement agencies. Therefore, entities operating in these industries must remain even more vigilant and knowledgeable about the legal and regulatory parameters affecting their companies to stay compliant and proactive and 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 to 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, and 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, as well as on 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, group purchasing organizations, managed care organizations, long-term care facilities, physicians, institutions, specialty pharmaceutical suppliers, federal and state purchasers (including state pharmaceutical assistance programs (or "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 managed care plans and consumers
Providing FDA counseling relating to promotional matters, non-promotional activities, continuing medical education 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 (CIAs) with the U.S. Department of Health and Human Services' Office of Inspector General (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, 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, gifts, compliance programs, pricing, clinical trials, pedigree, and related reporting requirements
Providing legislative industry updates and analyses