Petitioning the FDA to Improve Pharmaceutical, Device and Public Health Safety by Ordinary Citizens: A Descriptive Analysis

Abstract

The United States Constitution protects the right of citizens to petition the government for “a redress of grievances.” This right has important implications for citizens desiring to advance the public health by petitioning administrative agencies, such as the Food and Drug Administration, to take safety actions. We examined a total of 1,915 petitions filed between 2001 and 2013 to investigate the outcomes of citizen petitions that address public health concerns. We found that most petitions were filed by manufacturers against other manufacturers. Only 346 (18%) of all petitions were submitted by individuals and non-profit organizations, and 178 (87.3%) of these petitions with a final response were denied. On average, these petitions required 2.85 years for a final agency decision, and many decisions remain pending 10–13 years after their initial submission. The great majority of the approved requests included some form of risk communication, such as labeling changes, boxed warnings or placement of a drug into a Risk Evaluation and Mitigation Strategy. As a policy instrument to improve the safety of medical and food products, the citizen petition process requires sophisticated legal and scientific expertise, and may not represent a viable route for ordinary citizens to petition the FDA to “redress grievances.”

Adverse events associated with budesonide nasal irrigation reported to the US Food and Drug Administration: 2007 to 2022

“…Any manufacturer incurring the costs necessary to secure FDA approval would therefore be unable to prevent competition from other manufacturers 12 ; at present, the FDA has authorized eight manufacturers to market generic budesonide. 13 In the absence of manufacturer initiative, we believe professional societies-including the American Rhinologic Society, the American Academy of Otolaryngology-Head & Neck Surgery, and the Triological Society-should consider sponsoring a physician-led petition 12,14 to the FDA that synthesizes the clinical evidence supporting the safety [4][5][6] (including FAERS data) and efficacy of budesonide nasal irrigations for chronic rhinosinusitis treatment. [7][8][9] Such action may be the only viable pathway toward FDA approval.…”

“…In the absence of manufacturer initiative, we believe professional societies—including the American Rhinologic Society, the American Academy of Otolaryngology—Head & Neck Surgery, and the Triological Society—should consider sponsoring a physician‐led petition 12,14 to the FDA that synthesizes the clinical evidence supporting the safety 4–6 (including FAERS data) and efficacy of budesonide nasal irrigations for chronic rhinosinusitis treatment 7–9 . Such action may be the only viable pathway toward FDA approval.…”

When consumers lose power: An examination of the stakeholder dynamics in the pharmaceutical industry

“…We counted the number of drugs that were in a petition filed by individual citizens against a company each year, weighted by the petition status (0 = denied, 0.5 = partially granted; 1 = granted). Records on citizen petitions are available in the docket folders of http://www.regulations.gov (Chen et al, 2016). Such petitions include alleged toxic ingredients, lack of warnings on a package, alleged cancer‐inducing ingredients, the lack of required ingredients, and other alleged health damages.…”

Citizen Petition to the US Food and Drug Administration to Change Prescribing Guidelines: The Metformin Experience

“…Out of 1,915 citizen petitions that were filed between 2001 and 2013, 82% were filed by individuals working for industry. 5 Most of these petitions were focused primarily on blocking or delaying FDA approval of generic products in order to extend brand market profitability. When citizen petitions are filed by individuals or organizations not working on behalf of industry, they most often request labeling changes, addition or removal of boxed warnings, risk communications, or placement of drugs into a Risk Evaluation and Mitigation Strategy (REMS).…”

“…On average, it takes the FDA 3 years to reach a final decision, and it denies the petitioners’ request in the vast majority of cases (87%). 5 …”