Bringing a new pharma, biotech, or medical device product to market requires careful navigation of a highly regulated, complex, and dynamic regulatory landscape. If you are launching new products, indications, or sales and marketing tactics, Morningstar Law Group’s FDA compliance and healthcare regulatory attorneys can assist with pre-commercial and commercial matters to enhance the odds of success.
The U.S. Department of Justice, often in partnership with Food & Drug Administration (FDA) and Federal Trade Commission (FTC), continues to vigorously enforce fraud and abuse laws, such as the Anti-Kickback Statute and False Claims Act. Our pharmaceutical, biotech and medical device lawyers are familiar with the new and novel ways these cases are being pursued and can provide guidance to help you steer clear of potential legal actions.
Regulatory Compliance Counsel
Our FDA and healthcare regulatory attorneys also assist pharmaceutical and biotech companies engaged in product marketing, discounting, distribution, and/or sales activities with understanding, developing, and implementing policies for compliance with state and federal healthcare laws, regulations, and industry guidelines such as:
- Anti-Kickback Statute (AKS)
- False Claims Act (FCA)
- Department of Health and Human Services Office of the Inspector General (OIG)
- PhRMA Code and AdvaMed Code
- Physician Payments Sunshine Act / Open Payments
- Anti-Trust Laws (e.g., Sherman Act, Clayton Act, FTC Act, Robinson-Patman Act)
