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 claims the FDA failed to meet its legal obligation to respond to the petition in a timely manner. The lawsuit is asking the United States District Court for the District of Columbia to compel the FDA to respond to the citizen petition.