Citizen Petitions have become the subject of significant criticism recently, but they are nothing more than a public process for asking FDA to take – or refrain from taking – virtually any type of regulatory action. As such, they are valuable and cost-effective tools for companies seeking to achieve particular regulatory objectives.

Petitions can be used in a wide variety of contexts, from broad regulatory policy issues affecting a class of products to specific regulatory or legal issues affecting a single application. Moreover, while it is often preferable to resolve regulatory issues through private correspondence or meetings, filing a Citizen Petition – which is a public process – may be particularly useful where input from stakeholders, such as patient or physician groups, is warranted. Citizen Petitions also serve to “set the table” for potential litigation by exhausting administrative remedies and creating an administrative record for judicial review.

FDA Citizen Petition Expertise

Scott Lassman is a recognized expert on the proper and effective use of Citizen Petitions. He has written research articles on them and is widely quoted in the press on their use. More importantly, Scott has prepared scores of Citizen Petitions and petition responses for his clients over his nearly 30-year career. These petitions have covered a wide variety of regulatory issues, including:

  • orphan drug designation and exclusivity,
  • patent certification requirements,
  • 3-year and NCE exclusivity,
  • pediatric exclusivity,
  • 505(b)(2) applications,
  • labeling carve-outs,
  • naming conventions for biosimilars,
  • approval requirements for complex drugs,
  • approval requirements for drug-device combination products,
  • application of the Combination Rule to fixed-dose combination drugs, and
  • prescription drug user fees.

You are invited to contact Lassman Law+Policy for more information on the firm's counsel and advocacy with regard to FDA Citizens Petitions.