Linda Pissott Reig, Shareholder in the firm's FDA/Biotechnology section, will present a webcast titled "Innovator and Generic Drug Manufacturers: Implications of Legal, Regulatory and Political Updates on Safety, Oversight, REMS and Product Liability Risk," hosted by Practising Law Institute, on October 17 from 1:00 - 2:00 p.m.
FDA, fueled by concerns about drug pricing, is adopting measures to expedite generic drug approval. Meanwhile, the continuing growth of the generic drug market has exacerbated conflicts between innovator and generic drug manufacturers. Legal and regulatory issues that have long been considered resolved are now gaining greater importance in defining the respective roles of innovator and generic manufacturers. All signs point to increasing activity, particularly on the regulatory and liability fronts. This One-Hour Briefing will highlight three of the "hottest topics" in this area in 2017 and beyond.
Discussion will include:
How regulatory reform will impact both innovator and generic manufacturers, particularly relating to the potential impact of expanding the Changes Being Effected ("CBE") provisions to include generic drugs
The current status of liability of innovator manufacturers where only a generic form of the drug was administered, as well as the potential for increasing liability of generic manufacturers
The potential outcome of the ongoing conflict between utilization of Risk Evaluation and Mitigation Strategies ("REMS") as a barrier to generic entry or legitimate protection of intellectual property rights