Life Sciences

Life science companies face complex hurdles en route to the marketplace and may need assistance navigating agency regulations and steering clear of enforcement action. Recent regulatory changes, increased scrutiny of marketing and pricing issues, and complex intellectual property issues require realistic and effective strategies to stay competitive.

Our multidisciplinary life sciences team is experienced in regulatory compliance, unfair competition, product liability risk control, intellectual property, and enforcement. We advise on traditional and special regulatory issues and can help you participate in agency rulemaking, respond to federal and state administrative enforcement actions, and handle civil and criminal litigation.

When challenging issues arise, we provide sophisticated counseling and advice to help protect clients’ operations. Our attorneys have extensive experience representing clients before the FDA Consumer Product Safety Commission (CPSC), Drug Enforcement Agency (DEA), Environmental Protection Agency (EPA), Federal Trade Commission (FTC), and the U.S. Customs Service.

Our life sciences attorneys frequently lecture and write on topics in their specific areas of concentration, including health law, FDA regulatory law, fraud and abuse, health care reimbursement, intellectual property, HIPAA, international licensing, and technology, medical device, and biotechnology transactions.

How We Help Businesses

Enforcement actions, including product liability, recalls, seizures, FDA warning letters, and other notices of alleged violation
Facilities audits and FDA inspections
Regulatory and clinical research compliance
Third-party, government, and health insurance reimbursement
Recalls and corrective actions in conjunction with product liability
Legislative and regulatory advocacy and policy development
Compliance training and conduct audits
Foreign Corrupt Practices Act (FCPA) compliance plans
Analyzing permissible uses and disclosures of protected health information

Our Experience

Determining proper device classification
Complying with cGMP (current good manufacturing practices)
Obtaining investigational device exemptions (IDE)
Advising on medical device reporting (MDR) strategy and compliance
Advising on medical device pre-market applications, including 510(K) and PMAs
Advising on drug advertising, labeling, and promotional material, including Web sites and direct-to-consumer advertising
Addressing antitrust implications of bringing pharmaceuticals to market
Obtaining new drug approvals, including filing veterinary applications
Assisting in over-the-counter (OTC) drug manufacturer registration, product listing, and marketing compliance
Food labeling
Advising on importation of FDA-regulated products
Advising on supplier agreements and other contracts in the regulated industry
Advising on purchase and sale of businesses involving FDA-regulated products as assets, assignment, and transfer of FDA approvals and registrations