FDA and Life Sciences

Our FDA and life sciences lawyers advise clients in the pharmaceutical, biotechnology, medical devices, food, supplements, and diagnostic sectors on regulatory compliance, business transactions, and litigation. The team has experience in the government and military, industry, and the medical profession as engineers, chemists, computer scientists, and biologists. 

Manufacturers, developers, suppliers, distributors, clinical laboratories, and other regulated entities value our practical advice as well as our relationships with state and federal regulatory bodies. Our attorneys regularly advise clients and share insights on key developments and the impact of regulatory changes. 

Burr & Forman's long history serving the health care industry gives us particular knowledge and understanding that is valuable to our life sciences clients as they achieve advances in patient care through their studies and breakthroughs. We assist our clients in demonstrating safety and efficacy to the Food and Drug Administration (FDA) through the clearance and commercialization process for medical products. 

Our key services within the life sciences industry include:

• Pharmaceutical & Medical Device Regulatory Guidance
• Product Launch & Commercialization
• FCPA & Anti-Corruption Counseling 
• Consumer Products Regulatory & Litigation
• Patent Prosecution, IP Counseling, and IP Due Diligence
• Product Liability & Complex Tort 
• False Claims, Whistleblower, and Internal Investigations
• Class Action Defense
• Fraud, Waste, and Abuse

• Approvals, Clearances, and Grants

• FDA Submissions & Pre-Submissions

• FDA, FTC, and FCA Compliance Programs, Plans, and Counseling

• Advised a global medical technology company on multistate DMEPOS licensure requirements and multistate Stark and anti-kickback laws.
• Advised a global medical device manufacturer on setting up its organization as a certified/approved DME provider and supplier to sell and market its devices in multiple states amid the states’ varying qualifying criteria.
• Represented a life sciences client in the $50 million acquisition of a supplier, developer, and producer of turn-key biomanufacturing systems and production-scale bioreactors based around single-use components. This acquisition allowed the client to expand its health care offering of products and services to manufacture biopharmaceuticals like recombinant proteins, antibodies, and vaccines.
• Represented client in the $167 million, all cash sale of its medical products unit to a manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology, and endoscopy equipment. The deal expanded the acquirer’s existing OEM business.
• Counseled a medical device manufacturer through negotiating, drafting, and closing agreements involving the strategic and operational planning process for the divestiture of a business line involving a Canadian distributor.
• Defended a health care system in a drug diversion investigation by OIG.
• Defended a pharmaceutical company in federal court against allegations that it paid kickbacks to Medicare beneficiaries in violation of the anti-kickback statute by using a charity as an illegal conduit to cover the copays of Medicare patients who were taking the company’s pulmonary arterial hypertension drugs.
• Defended a drug wholesale company and its subsidiaries in a federal court action against allegations under the False Claims Act (FCA) arising from their operation of a facility that allegedly improperly repackaged oncology-supportive injectable drugs into pre-filled syringes
  and distributed those syringes to physicians treating cancer patients.
• Defended a drug company’s wholly-owned subsidiary in federal court against allegations that it illegally distributed misbranded drugs from a facility not registered with the Food and Drug Administration (FDA).
• Defended a medical device manufacturer of ultrasound equipment in product liability action amid disputed FDA categorization of the device as Class II or III medical device.