Pharmaceutical, DEA Regulatory & FDA Compliance

Ogden Murphy Wallace provides skilled advice, guidance, and defense in all aspects of pharmacy law, DEA regulatory law, and FDA compliance.

Our pharmacy team is headed by Ronald Friedman, a graduate of Harvard Law School, a former federal prosecutor and member of the American Society of Pharmacy Law.

Our clients include pharmacies, clinics, hospitals, practitioners, and pharmaceutical and medical device suppliers and distributors throughout the United States. Our team has extensive legal experience in all aspects of pharmaceutical compliance.

We help individuals and businesses navigate complex problems, obtain proper licensing and regulatory approval, and avoid adverse regulatory action. We are skilled at responding to an investigation, developing due diligence protocols, and providing a defense in regulatory proceedings by the United States Department of Justice, the Drug Enforcement Administration, the Food and Drug Administration, the Office of Inspector General, and Departments of Health and Boards of Pharmacy throughout the United States. We are skilled at responding to administrative, civil, and criminal investigations.

We believe in working collaboratively to find common solutions to practical problems and avoiding unwarranted discipline.

In addition to medical products, our lawyers have extensive experience representing food and consumable manufacturers and distributors in FDA and Department of Agriculture compliance proceedings, including addressing potential warning letters, recalls, and helping develop due diligence protocols.

Pharmacies and Distributors

• Represented regional drug chain in False Claims Act action brought by U.S. Department of Justice. Matter settled for 4% of government’s demand.
• Represented healthcare diagnostic laboratory in HIPAA compliance action; no charges brought.
• Represented national drug manufacturer in civil action by state Attorney General alleging negligence, public nuisance, violations of state consumer protection act.
• Represented national retail drug chain in DEA compliance investigation
• Represented national drug wholesaler in board of pharmacy compliance investigation
• Represented a major league sports franchise in DEA regulatory investigation; no charges brought
• Represented national drug distributor in Board of Pharmacy compliance proceedings

• Represented clinic-based pharmacy in FDA compliance investigation. Successfully resolved
• Represented compounding pharmacy in FDA compliance investigation. Successfully resolved

Physicians, Hospitals and Clinics

• Represented numerous physicians in responding to Medical Quality Assurance Commission investigations and developing due diligence protocols
• Represented medical trauma training center in DEA regulatory compliance investigation
• Provided guidance to hospitals regarding handling and record-keeping relating to controlled substances
• Represented physician in criminal investigation alleging unlawful inducement/kickbacks. No charges brought.
• Represented physician in criminal investigation alleging unlawful distribution of a controlled substance. No charges brought.
• Represented multiple pain clinics and physicians in DEA and state board compliance investigations across the United States
• Represented physicians and facilities in responding to third-party audits
• Represented drug addiction/buprenorphine clinics in regulatory investigations by DEA and Attorney General

Food and Consumables

• Represented national tea manufacturer in FDA and Department of Agriculture adulterated product investigation. Recall and fines avoided.
• Represented U.S. birthing product importer in FDA investigation where shipments seized. Recall and fines avoided.
• Represented British Columbia-based cosmetic manufacturer in FDA investigation relating to use of unapproved ingredients. Fines and recall avoided.
• Represented Washington farming consortium in federal investigation relating to potential violations of federal law. No charges brought.
• Representing a Canadian food importer (mushrooms) in FDA adulterated product investigation. Recall and fines avoided.
• Represented domestic cheese manufacturer/distributor in licensing and regulatory matters.