Pharmaceuticals
Drug manufacturers face numerous pressures from seemingly endless directions, including competitors with alternative brands in the same therapeutic space or generics, insurers, political pressures, and ever-increasing public scrutiny and regulatory landscape. Clients value our extensive experience in pharmaceuticals. With our industry and scientific backgrounds, we understand the complex and nuanced business and legal intricacies pharmaceutical companies face on a daily basis. The team at Kendall PC draws on decades of first-hand experience to solve our clients’ complex challenges. As a result of our long and deep work in the sector, Kendall PC has extensive knowledge of the governing laws and regulations, broad-based practical experience with real-world application, and an intimate knowledge of government enforcement practices and authorities. We know that our clients’ success in such a highly regulated market requires practical, integrated legal analysis and advice.
Kendall PC offers the complete spectrum of services to support clients in the pharmaceuticals sector. We assist with innovation and emerging business and startup issues in addition to research, development, and regulatory approval challenges in bringing products to market. We help businesses navigate the challenges of commercialization and post-market enforcement, and handle issues related to product liability, data privacy, commercial contracting, mass tort and other litigation. We regularly advise manufacturers, distributors, and other companies of all sizes and stages in the product life cycle.
Contact the experienced attorneys at Kendall PC today online or at (484) 414-4093. We serve clients throughout the United States and across the globe.
Pharmaceutical, Biotechnology, and Medical Device Commercialization
The pharmaceutical, biotechnology, and medical device commercialization team of attorneys at Kendall PC knows that our clients need a legal partner who understands the big picture, from patent strategies and market position to risk-impact assessments of potential activities and the implications for overall business operations. We counsel clients on:
- Regulatory filings and communications
- Promotional review committees (medical, legal & regulatory review committee)
- Development, manufacturing, and supply agreements
- Sales and distribution contracting: PBM, wholesaler, and 3PL contracting
- Manufacturing, distribution, and wholesale licensure
- Open Payments (Sunshine Act) compliance
Litigation
When disputes arise, our litigation team works to preserve clients’ interests, assets and reputations quickly and efficiently. Drawing on our cross-disciplinary regulatory, pharmaceutical commercialization, investigations, healthcare and clinical compliance, and data protection and privacy teams, we provide comprehensive litigation advice and strategies in the most complex pharmaceutical disputes including:
- Healthcare litigation
- Settlement discussions
- Anti-Kickback Statute litigation
- Healthcare Fraud Statute litigation
- Responsible Corporate Officer Doctrine disputes
- US False Claims Act litigation
- Physician Self-Referral (Stark) Law litigation
- Consumer class action and other consumer-related litigation
- Development, production, sale, and distribution disputes
Mass Tort and Toxic Tort Defense
The mass tort and toxic tort defense team of attorneys at Kendall PC has significant experience managing mass tort litigation for pharmaceutical companies. Drawing upon deep industry knowledge as well as technical proficiency, our attorneys have experience serving as national coordinating counsel in state and federal courts throughout the country. Kendall PC has a track record of representing the pharmaceutical sector in mass tort and toxic tort litigation, including successful exclusions of general causation experts via Daubert hearings and trials, defending petitions to create Multidistrict Litigation (MDL) in nationwide pharmaceutical products liability actions, conducting expert discovery, and mapping strategies to obtain important early substantive motion victories for our clients.
Healthcare and Clinical Compliance
The healthcare and clinical compliance team of attorneys at Kendall PC advises on a wide range of compliance topics to guide our pharmaceutical company clients through the evolving legal compliance requirements and governmental oversight from the U.S. Food and Drug Administration (FDA), U.S. Federal Trade Commission (FTC), U.S. Health and Human Services (HHS), and Department of Justice (DOJ). We work with our clients to implement effective and cost-efficient compliance strategies tailored to protect our clients’ interests.
Within these areas, our work typically encompasses:
- Policy development and implementation
- Compliance training
- Risk assessments, audits, and gap analysis
- Day-to-day “help desk” compliance support
- Industry benchmarking
- Due diligence and monitoring processes
Regulatory Counsel
Kendall PC’s regulatory practice is focused on delivering comprehensive and sophisticated assistance to clients in all facets and sectors of pharmaceutical product regulation. Our team of regulatory attorneys counsels clients on the regulatory impact to business operations and endeavors including U.S. FDA regulatory strategies, clinical trials, inspections, promotion, and advertising, fraud and abuse, pricing, contracting, coverage and reimbursement, compliance program support, transactional diligence and post-transaction integration, and various state and federal reporting obligations. We provide assistance to clients on:
- US Food and Drug Administration (FDA) compliance matters
- Regulatory approval pathway strategies
- Clinical trial design
- Orphan drug submissions
- Investigational new drug and new drug applications
- Hatch-Waxman strategies
- FDA advisory committee matters and dispute resolution
- Government sales and contracting disputes
- Reimbursement strategies
- Availability market exclusivity assessments
- Promotional, reimbursement, marketing, distribution, and pricing strategies
- Labeling and advertising matters
- Manufacturing processes
- Recall, correction, removal, and supply chain issues
- Comparative effectiveness research
- Export and import matters
- Product modifications
- Quality system regulation issues
- Medicare, Medicaid, and other federal healthcare program coverage and reimbursement
- Sunshine compliance
- State distribution compliance matters
- State license registration matters
- State price reporting matters
- 483 Observations and Warning Letters
Government Investigations
Kendall PC handles investigations by a range of law enforcement agencies, including the U.S. attorney’s offices, the DOJ, and state attorneys general. We have extensive experience in defending pharmaceutical companies in government investigations into alleged violations under the Federal Food, Drug and Cosmetic Act, the Anti-Kickback Statute, and state and federal False Claims Acts, among others. We handle complex multiagency government investigations, including managing parallel investigations by federal and state government entities and settlement and corporate integrity agreement (CIA) discussions and negotiations.
Our government investigations team of attorneys counsel clients on the following government investigation matters:
- Suspensions and debarments
- Anti-Kickback Statute
- FDA Form 483 and Warning Letter Responses
- Foreign Corrupt Practices Act, UK Bribery Act, and other fraud and corruption matters investigations
- False Claims Act investigations
- Deferred prosecution agreements
- US federal and state government civil investigative demands and administrative subpoenas
- Corporate Integrity Agreement (CIA) negotiations
- Billing and coding practices
- Drug price reporting practices, including discounting and rebate practices
- Medicare, Medicaid, and other US healthcare program matters
Internal Investigations
The seasoned internal investigations attorneys at Kendall PC have wide-ranging experience in conducting internal investigations for an array of publicly traded and private organizations and entities. Our internal investigations team possesses cross-disciplinary regulatory, corporate, commercial compliance, and litigation know-how to assist clients with these sensitive and highly complex matters. We work with our clients to assess potential exposure, reduce costs and damages, and resolve issues expediently to bring the investigation to an acceptable end. Our attorneys also guide entities post-investigation to successfully maintain reputation and goodwill and retain business.
Our internal investigations team has experience in investigations concerning:
- Audit committee inquiries into illegal or improper conduct
- Corporate governance, risk management practices and compliance programs
- Diligence in connection with M&A transactions
- Export Compliance
- The False Claims Act, qui tam actions, and government contract billing
- The Foreign Corrupt Practices Act
- Restatements
- Section 10A
- Shareholder and other derivative demands
- Special litigation committees
- Whistleblower and other investigations under Sarbanes-Oxley
- Healthcare fraud
- FDA violations
Commercial Contracting
Kendall PC’s commercial contracting combines legal knowledge with deep sector experience to cover the full spectrum of commercial and business law issues. Every day, companies must address a myriad of relationships and contracts that bind them to their suppliers, customers, licensors, distributors, and other strategic partners. These complexities are intensified by the regulatory obligations that impact every facet of operations within the pharmaceutical sector. Our team of attorneys has decades of experience advising pharmaceutical companies on business-critical commercial transactions, among them:
- Manufacturing and supply
- Product development
- Sales and distribution
- Logistics and warehousing
- Master service
- Software as a Service (SaaS)
- Commercial lease
- Intellectual property agreements
Data Protection and Privacy
The data protection and privacy team at Kendall PC focuses on the evolving technological and legal issues of businesses relating to the security and privacy of networks and data. We represent pharmaceutical clients in counseling, transactions, investigations, government relations, and responses to data breach and security incidents. We have extensive experience with data protection and privacy matters pertinent to pharmaceutical manufacturers, distributors, and other entities including the application of:
- EU General Data Protection Regulation (GDPR)
- California Consumer Privacy Act (CCPA) / California Privacy Rights Act (CRPA)
- Health Insurance Portability and Accountability Act (HIPAA)
- Health Information Technology for Economic and Clinical Health (HITECH) Act
- Federal Trade Commission (FTC) Act
- Children’s Online Privacy Protection Act (COPPAA)
- CAN-SPAM Act
- US state security breach notification law compliance
- Medical privacy law matters
- Information disclosure and compliance training
Business Startup, Formation and Corporate Governance
We conduct due diligence reviews for pharmaceutical companies engaging in acquisitions, mergers, licensing deals, and investments, including those pertaining to FDA-regulated companies and/or products. Our business, startup, formation, and corporate governance and regulatory teams work together to identify and evaluate the myriad of regulatory issues that may affect the proposed transactions. We are also able to provide business startup and formation services to emerging entities in the pharmaceutical space.
Contact Kendall PC Today
If your business is in the pharmaceuticals sector and needs support from an experienced team of knowledgeable attorneys, contact Kendall PC today online or at (484) 414-4093. We serve companies of all sizes throughout the United States and across the globe.
