Discussing a panel presented at the 2016 Food and Drug Law Institute (FDLI) Annual Conference, Shook, Hardy & Bacon Senior Associate Gregg Webb outlines the advantages and challenges of the Food and Drug Administration's (FDA's) citizen petition process in the May/June issue of FDLI's Update magazine. Titled "The Citizen Petition Process: An Engine for Democracy and Debate," the article addresses the origins, benefits and drawbacks of the citizen petition process; best practices for submitting petitions; petition case studies; and "the significant controversy that certain petitions have created, particularly in the drug approval context."
As Webb reports, Alston & Bird Partner Marc Scheineson explained that the citizen petition process allows parties to advocate for policy or regulatory change while permitting judicial review when FDA rejects a petition. But panelists also suggested that "petitions often have 'few teeth' and are frequently denied by the agency," creating "additional work for FDA staff and decision-makers that may sour relations with the agency." To increase "the likelihood of receiving of a (reasonably) prompt and favorable response," Scheineson "noted the critical importance of submitting well-reasoned, well-researched, well-written, and well-documented petitions and emphasized the value of interacting with the agency on multiple levels."
In addition, the article analyzes efforts to refine the process and reduce delays, such as those that occur when petitions slow down Abbreviated New Drug Application (ANDA) approvals. Observing that "the results of this regulatory tightening have been mixed," Webb highlights the FDA Amendments Act—which added Section 505(q) to the Food, Drug and Cosmetic Act to address citizen petitions involving pending ANDAs and 505(b)(2) applications—as well as the FDA Safety and Innovation Act, which expanded "the scope of 505(q) to include certain petitions related to biosimilar applications."
"When used properly, the citizen petition represents a pragmatic tool for facilitating public access to FDA, elevating issues and evidence of concern to agency decision-makers, and promoting dialogue among stakeholders across nearly every area of the regulatory landscape," concludes Webb. " But, as with any genuinely democratic device, the citizen petition process only works when participants use it for appropriate ends and with a larger public interest in mind, even when seeking purely private objectives."