Services--Advertising & Promotion of FDA-Regulated Products


Promotional Review Process

   ♦ SOP drafting and review
   ♦ Pre-release reviews
      • press releases
      • web sites
      • print and TV ads and scripts 

   ♦ Substantiation processes

   ♦ Ensuring Fair Balance

Off-Label Promotion

   ♦ Industry Supported Scientific Educational Activities

   ♦ Reprints

   ♦ Replying to Unsolicited Off-label Requests

   ♦ Impact of Caronia and Amarin cases

      • Need for adequate directions for use

      • Doctrine of "intended use"

Social Media and Internet Advertising

   ♦ Space-limited promotion (e.g., tweets, ads)

   ♦ Correcting User Generated Content (UGC)

   ♦ 2253 submissions for internet content

Direct-to-Consumer (DTC) Marketing

   ♦ "Adequate" Provision 

   ♦ Print vs. TV requirements

   ♦ Reminder ads

   ♦ "Health Seeking" ads


   ♦ Defending Against FDA Regulatory Action
       • Warning Letters
       • "Untitled" Letters
   ♦ Defending Against Actions by Competitors
       • NAD
       • Lanham Act Litigation 

Role of the Federal Trade Commission (FTC)

   ♦ The "Competent & Reliable Scientific Evidence" Standard

   ♦ The Pom Wonderful Case and substantiating health claims

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