New OTC Labeling Guidances

New OTC Labeling Guidances - Webinar CD/Transcript

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New OTC Labeling Guidances: Understanding Self-Selection Studies and Failure-to-Warn Lawsuits

OTC manufacturers are scratching their heads over new OTC labeling guidance from the FDA. Wrong moves can lead to multimillion-dollar lawsuits. To protect yourself, please read on ...

Welcome to OTC labeling, 2013 version.

If you’re converting from Rx to OTC, expanding (or restricting) your indication to a new patient population or have made usage or labeling changes, you had better be prepared with documented studies ready for FDA review.

The FDA’s new guidance — Self-Selection Studies For Non-Prescription Products — details four important features of an OTC product that it recommends should prompt a self-selection study:

  1. The drug is for a new nonprescription indication
  2. The drug product is for a new nonprescription population
  3. There are specific populations who should not use the proposed nonprescription drug product (e.g. diabetics, transplant recipients)
  4. A substantial labeling change has been proposed for an approved nonprescription drug product that may affect the appropriate nonprescription population (e.g. a change in warning, directions for use)

Current law requires that OTC labels be “likely to be read and understood by the ordinary individual under customary conditions of purchase and use.”

Failure to create fully informative, yet fully understandable, OTC labels can result in violations of the FDCA and or subject a drug company to a failure-to-warn civil suit that can result in millions in litigation-related expenses.

Your instructor, Kari Sutherland Esq., is uniquely qualified to explain and clarify the new FDA guidance. In 90 fast-paced minutes, she walks you through the new guidance’s seven recommendations for designing self-selection studies:

  1. Study Objectives
  2. Study Population
  3. Statistical Considerations and Data Analysis
  4. Questionnaire Design
  5. Study Conduct
  6. Validating the Self Selection Decision
  7. Data Collecting and Recording

And that’s not all. You’ll also discover how improved OTC label design helps cut your risk of lawsuits, and the background of OTC labeling … including goals and action items of the 2006 Advisory Committee that first tackled OTC labeling issues … and much more!

Don’t risk costly, damaging litigation or FDA actions — not when you can learn what you need to know in just 90 minutes.

  • Regulatory professionals
  • Industry counsel
  • Brand manufacturers
  • OTC manufacturers
  • Contract manufacturers
  • Contract labelers

Kari Sutherland, an attorney at Butler, Snow, O’Mara, Stevens & Cannada, PLLC, was recently named to Benchmark Litigation’s “Top 250 Women in Litigation” list. She serves clients in the areas of drug and medical device, product liability and appellate litigation. Her background includes clerkships for U.S. District and Appellate judges, and service with the Department of Homeland Security.