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Brian Bohnenkamp specializes in regulatory and compliance matters relating to drug, biotechnology and medical device companies. A partner in our FDA practice and a member of our Life Sciences group, Brian has extensive experience counseling manufacturers on fraud and abuse laws, industry codes of conduct, federal and state transparency laws and regulations, state and local gift bans, compliance program laws and sales representative licensing requirements, as well as government ethics restrictions.
With a master’s degree in healthcare administration, Brian provides counsel to companies on a variety of laws and regulations administered and enforced by FDA, OIG, DOJ, and CMS, as well as by state attorneys general, boards of pharmacy, departments of health, and similar administrative and enforcement authorities. He regularly assists manufacturers in designing and implementing comprehensive compliance programs, and conducts risk assessments, audits and other reviews of compliance programs and business activities/operations.
Brian is regarded as a national expert on life sciences transparency laws and regulations, including the federal Physician Payments Sunshine Act (aka Open Payments) and similar state laws. He provides counsel to the Ad Hoc Sunshine and State Law Compliance Group, a coalition of pharmaceutical, biotechnology and medical device manufacturers.
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