Background - Practices (Details)

Pharmaceutical Industry and Prescription Drugs

Crowell & Moring lawyers have deep experience working directly on issues involving pharmaceutical companies, pharmacy benefit managers (PBMs), pharmacy organizations, and medical technology and equipment companies on a broad range of transactional, regulatory, compliance, antitrust, intellectual property, and general commercial litigation matters.

Regulatory and Fraud and Abuse Compliance

Crowell & Moring's premier compliance practice includes representing PBMs, drug manufacturers, pharmacy organizations, and medical technology and equipment companies on a variety of regulatory and fraud and abuse issues, including Medicaid "best price," Section 340B pricing, and other statutory pricing requirements, federal and state anti-kickback and consumer protection laws, legal risks associated with potential conflicts of interest in business relationships, and DEA investigations of pharmacy drug handling and recordkeeping. Our lawyers have experience analyzing the development and implementation of formularies, reimbursement practices, and rebate and incentive arrangements between manufacturers and providers, payors, and PBMs. We have also counseled clients on a variety of industry-supported educational and scientific activities and service arrangements. Our lawyers have government experience that includes service with the U.S. Food and Drug Administration, with broad law enforcement responsibility for actions involving pharmaceuticals, medical devices, food, and veterinary drugs. In addition to counseling a wide variety of clients on these matters, our team has also developed compliance programs and policies, and conducted internal investigations and compliance reviews.

Business Transactions

Crowell & Moring represents clients in a variety of corporate securities and business transactions, including a variety of finance transactions, cross-border transactions, initial public offerings (IPOs), mergers and acquisitions, rebate arrangements, formulary and disease management programs, data transfer and licensing agreements, domestic and global distribution agreements, scientific research funding arrangements, and wholesaler joint ventures and marketing arrangements. Crowell & Moring also represents clients in the purchase and sale of specialty and mail service pharmacies, PBMs, and related entities.

Specialty, Mail Service, and Long-Term Care Pharmacy and Clinical Research

Crowell & Moring has extensive depth in issues affecting specialty, mail service, and long-term care pharmacies, and consultant pharmacists serving patients in institutional settings. We handle the range of legal issues that arise in clinical trials and medical research, including Food and Drug Administration (FDA) and National Institutes of Health (NIH) requirements, clinical research organization operations, privacy, anti-kickback law compliance, and conflict of interest issues.

We have applied our experience in a number of different practice areas to pharmaceutical, medical technology, managed care and other health care clients, including the following disciplines:

Antitrust. Crowell & Moring handles a broad range of antitrust and trade regulation litigation and counseling matters for pharmaceutical companies, pharmacies, medical technology and equipment companies, managed care companies, and prescription benefit management companies, including brand-generic competition restraints, price discrimination issues, distribution-related challenges, unfair competition claims, and exclusion of pharmacy chains from managed care networks.

Government contracts. Crowell & Moring has counseled pharmaceutical manufacturers, medical technology and equipment manufacturers, and prescription benefit managers on Veterans Administration (VA) and General Services Administration (GSA) procurements, Federal Supply Service defective pricing issues, Federal Employees Health Benefit Program requirements, issues related to Medicaid rebates, and matters related to the Multiple Award Schedule.

Litigation and investigations. Crowell & Moring lawyers have represented leading drug manufacturers, medical technology and equipment manufacturers, and prescription benefit management companies in antitrust litigation and unfair trade practice investigations, including inquiries by state attorneys general, the Drug Enforcement Administration (DEA), and state pharmacy boards. Our lawyers also served successfully as defense counsel in state antitrust litigation challenging allegedly discriminatory pharmaceutical pricing. We have also represented clients in fraud and abuse investigations involving rebate arrangements, represented manufacturer employees in Securities and Exchange Commission (SEC) investigations, and represented manufacturers in Superfund and environmental crimes litigation and investigations.

Patents and intellectual property. Crowell & Moring provides a full range of patent law services to pharmaceutical industry clients, including patent prosecution and litigation involving patent validity and enforceability.

Torts/product liability. Crowell & Moring's Mass Tort, Product, and Consumer Litigation Group delivers the full gamut of torts capabilities, including class actions, multi-district proceedings, and national and regional coordination of litigation. Our lawyers have litigated large-scale product/torts lawsuits involving pharmaceuticals, toxic substances, and trade association liability matters. Crowell & Moring lawyers have also litigated other significant fraud/product claims, including the high-profile Ritalin pharmaceutical consumer fraud/personal injury cases. Our lawyers also regularly handle matters involving product safety, including advising clients on when to report product issues, how to interact with the government on products matters, recall and related remedy options, retention of experts, and associated testing issues for agency proceedings.

Torts prevention and counseling. Our substantial product litigation experience positions us well to help our clients avoid litigation. Our clients involve us before litigation breaks out, and we help them avoid it. Our preventive counseling efforts range from guidance on product labels and warranties, to disclaimers and limitations of liability, to litigation risk analysis around budding disputes. We are also actively assisting clients with crisis management initiatives, and have alliances with the litigation communications and media relations consultants and scientific experts necessary to deliver our clients full-service counseling. We also utilize our experience with Six Sigma methodology to bring efficiency to product development and liability avoidance efforts.

International law and regulation. Lawyers from Crowell & Moring's offices in the United States, London, and Brussels advise pharmaceutical industry and other clients on the application and interpretation of European Union directives relating to pharmaceutical businesses and all regulatory matters concerning marketed products, including labeling and advertising. We also handle litigation for pharmaceutical companies, prepare and negotiate research, development, licensing, and manufacturing agreements for corporate and commercial transactions, advise on licensing of medical products, handle antitrust and competition matters, and counsel and represent clients on import and export controls matters.