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Innovator and Generic Drug Manufacturers: Implications of Legal, Regulatory and Political Updates on Safety Oversight, REMS and Product Liability Risk

Recorded on: Oct. 18, 2017
Running Time: 01:06:03

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Taken from the briefing Innovator and Generic Drug Manufacturers:  Implications of Legal, Regulatory and Political Updates on Safety Oversight, REMS and Product Liability Risk recorded October 2017 in New York.

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.

The speakers are Howard L. Dorfman (H.L. Dorfman Pharmaceutical Consulting, LLC; Adjunct Professor, Seton Hall School of Law) and Linda Pissott Reig (Shareholder, Buchanan Ingersoll & Rooney PC; Co-Chair, FDA/Biotech Group; Adjunct Professor, Rutgers University - MBA in Pharmaceutical Management). Howard is editor and a contributor of PLI’s Pharmaceutical Compliance and Enforcement Answer Book, and Linda is a major contributor to the book.

Lecture Topics  [01:06:03]

Expert faculty will discuss:

  • 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

Presentation Material

  • Impact of FDA Regulatory and Compliance Oversight on Product Liability Exposure of Pharmaceutical Manufacturers
    Howard L. Dorfman, Linda Pissott Reig
  • Implications of Legal, Regulatory & Political Updates on Safety Oversight, REMS and Product Liability Risk
    Howard L. Dorfman, Linda Pissott Reig
Speaker(s)
Howard L Dorfman ~ H. L. Dorfman Pharmaceutical Consulting, LLC
Linda P Reig ~ Buchanan Ingersoll & Rooney PC
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