LIFE SCIENCES INDUSTRY / LIFE SCIENCES REGULATORY COUNSELING & COMPLIANCE
Life sciences companies are faced with an increasing number of regulatory requirements that can span across various business operations, functions, and geographies. Compliance failures can be costly and can lead to reputational risk. Now, more than ever, it is important for life sciences companies to identify, analyze and mitigate risk to ensure long term sustainability within the industry.
Our Life Sciences team uses a collaborative approach to educate and guide life sciences clients through a wide range of potential regulatory issues, including compliance with federal and state health care program laws, regulations, and industry codes of conduct. This includes compliance with the following:
- AdvaMed Code of Ethics on Interactions with Health Care Professionals;
- Anti-kickback laws;
- Civil monetary penalties (CMP) law;
- Coverage and reimbursement requirements;
- Drug enforcement administration (DEA) regulations;
- Eliminating Kickbacks in Recovery Act (EKRA);
- False claims acts;
- Federal Food, Drug & Cosmetic Act (FDCA);
- Food and Drug Administration (FDA) laws and regulations;
- Health care reform laws and regulations;
- Health Insurance Portability and Accountability Act (HIPAA), privacy and cybersecurity;
- Licensure and accreditation requirements;
- Office of Inspector General (OIG) compliance guidance;
- Pharmaceutical Research and Manufacturers of America Code on Interactions with Health Care Professionals (PhRMA Code);
- Prescription Drug User Fee Act (PDUFA);
- Physician self-referral laws, including the Stark Law;
- Sunshine and transparency laws;
- Telehealth/telemedicine/mHealth laws;
- U.S. Federal Sentencing Guidelines; and
- Federal Acquisition Regulations (FAR).
We represent life sciences clients in responding to administrative, civil, criminal, and grand jury subpoenas, Congressional inquiries, and agency audits or notices, including the defense of claims brought under the federal False Claims Act (FCA), Anti-Kickback Statute (AKS), EKRA, CMP Law, and HIPAA. We also assist clients with remediation efforts, including conducting internal investigations, advising regarding self-disclosure obligations, negotiating settlement agreements, and implementing integrity obligations.