fda litigation, 2024

In May 2024, Dr. Antonei Csoka, a professor at Howard University in Washington DC, filed a lawsuit against the U.S. Food and Drug Administration (FDA) for its failure to act on a citizen petition. Public Citizen Litigation Group is the non-profit law firm representing Dr. Csoka in this case.

In May 2018, Data Based Medicine Americas Ltd. submitted a citizen petition about PSSD, which was signed by 22 experts, including Dr. Csoka. The petition requested that the FDA add warnings to SSRIs and SNRIs about the severe and long-lasting sexual effects some individuals suffer after discontinuing.

Dr. Csoka's lawsuit claimed the FDA failed to meet its legal obligation to respond to the petition in a timely manner. The lawsuit asked the United States District Court for the District of Columbia to compel the FDA to respond to the citizen petition.

Unfortunately, on March 31, 2025 the court dismissed the lawsuit on a legal technicality.  The court ruled that Dr. Csoka doesn't have standing to sue the FDA over this matter.  This decision doesn't mean the FDA isn't convinced that PSSD is real or the agency won't require a warning.  The FDA will still probably add a warning but there won't be a court imposed deadline for when they have to respond to the citizen petition.