- The current legal, regulatory and compliance issues relating to off-label promotion
- Drawing the distinction between “dissemination of accurate scientific and medical information” and “off-label promotion”
- FDA’s Draft Guidance on responding to unsolicited requests for “off-label” use- have the rules changed?
- Citizen Petition seeking clarification on the “off-label” rules
- Dissemination of third party clinical practice guidelines
- Forecasting potential effects of United States v. Caronia
- The role of the OIG and the states in prosecutions for off-label promotion
- How various Corporate Integrity Agreements address potential off-label promotion- what can we learn?
- Off-label and product liability
- The Allergan and Par litigation against FDA and interaction with OIG prosecutions
Participants that will find this webinar most beneficial will be those involved in medical device, pharmaceutical, biotechnology, and diagnostic companies. Job titles of attendees that will be most applicable for this session will be:
- Regulatory Affairs
- Corporate Counsel
- Promotion Compliance
- Legal Affairs
Howard L. Dorfman
Vice President and General Counsel
Ferring Pharmaceuticals Inc
Howard L. Dorfman, Vice President and General Counsel, Ferring Pharmaceuticals Inc
Howard L. Dorfman is Vice President and General Counsel at Ferring Pharmaceuticals Inc., the U.S.-based subsidiary of Ferring Holding, a pharmaceutical, medical device and biotech company based in St. Prex, Switzerland, where he is responsible for all legal matters relating to the company’s U.S. operations. Prior to joining Ferring, he was Counsel in the Life Sciences group at Ropes & Gray LLP in New York City where his practice focused on providing guidance to the pharmaceutical, medical device and biotech industries. Howard’s major areas of expertise include FDA regulatory law; fraud and abuse; health care compliance programs; risk management processes; mergers and acquisitions; corporate governance; licensing and product liability.