Responding to an OPDP Titled/Untitled Letter - Webinar CD/Transcript

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Responding to an OPDP Titled/Untitled Letter

It’s a changing landscape when it comes to regulating drug promotion.

Johnson & Johnson, GSK and Pfizer have faced fines for their promotions and Pacira and Amarin are changing the law in new ways.

How should you respond if your company — despite your best efforts — finds itself on the receiving end of a single titled or untitled letter from the Office of Prescription Drug Promotion (OPDP)?

Darshan Kularni of the Kulkarni Law Firm breaks down the types of possible enforcement activities and recent trends.  You will find out the following:

  • Should you always respond to an enforcement action?
  • What is the time frame for and goal of your response?
  • What exactly needs to be included in the response and what should be left out?
  • Who should sign the response?
  • When do you need outside help?

Drug promotion rules are growing more complicated.  Order your copy today for a detailed breakdown of what a drug promotion warning letter response needs to include.

  • Compliance officers
  • Consultants/service providers
  • Executive management
  • General/corporate counsel
  • Managers
  • Personnel new to the industry
  • Regulatory/legislative affairs professionals
  • Risk management specialists
  • Sales/marketing personnel
  • Strategic planning and business development staff

Darshan Kulkarni of the Kulkarni Law Firm is a leading expert on strategic regulatory and pharmaceutical counseling. With a background in both the law and hands-on healthcare experience (over 10 years as a pharmacist, including participation as a clinician in clinical trials), Mr. Kulkarni is versed in the needs of international device, pharmaceutical and biopharmaceutical companies and their service providers, including contract manufacturing organizations and contract research organizations.