Providing Workable Solutions for the Industry
Life sciences companies and laboratories operate in a complex marketplace, characterized by rapid growth, increasing competition and an ever-changing regulatory framework. The attorneys at HMBR understand these challenges and are well situated to help companies overcome obstacles and realize commercial success. We leverage decades of legal and regulatory experience to advise clients on a diverse range of industry disciplines, including:
- Pharmaceutical companies. Traditional pharmaceutical companies must address a host of complex legal and regulatory issues, ranging from fraud and abuse concerns associated with clinical research activities, to licensure matters, to compliance with evolving legislation at both the state and federal levels.
- Manufacturers and distributors of medical devices and supplies. Companies that manufacture and distribute medical devices and supplies can face tremendous scrutiny by the Office of Inspector General (OIG) and other regulatory authorities. These enterprises must comply with a myriad of laws and regulations, ranging from the federal Anti-Kickback Statute and Stark Law to the False Claims Act.
- Retail pharmacies. As health care delivery models continue to evolve, the nation’s largest pharmacy chains are increasingly developing and expanding their retail health clinic operations. When moving into the role of the provider, retail pharmacies must address a multitude of complex legal and regulatory issues, from prohibitions against the corporate practice of medicine to ensuring the privacy and security of protected health information.
- Laboratories. Laboratories and laboratory management companies are subject to an expanding body of laws and regulations, including federal and state anti-kickback and fraud and abuse statutes.
As the life sciences industry continues to expand and evolve, companies are likely to face increased oversight and scrutiny from regulatory authorities. Whether our clients are moving into a newly emerging arena such as stem cell acquisition or creating a mobile health application or looking for compliance guidance under fraud and abuse laws, our attorneys closely monitor legal developments so that we can provide timely and strategic advice on the issues that impact our clients’ activities.