Seven Pharmaceutical Companies Submit Joint Citizen Petition to FDA


Did You Know?

A recent blog post written by attorney Dara Katcher Levy describes a citizen petition that was recently submitted by seven pharmaceutical companies requesting more clarification regarding off-label use manufacturer-communications. Specifically, as described by Levy, the companies wrote the petition to request more hard-fast rules and information regarding the following four types of off-label use manufacturer-communications:

  • Manufacturer Responses to Unsolicited Request
  • Scientific Exchange
  • Interactions with Formulary Committees, Payors, and Similar Entities
  • Dissemination of Third-Party Clinical Practice Guidelines

Levy goes on to explain that pharmaceutical companies are looking for specified rules (as opposed to full-scale guidance documents) and for the clarification of various confusions related to off-label use manufacturer-communications.

See full blog entry.


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