S. 148 would authorize the Federal Trade Commission (FTC) to initiate a civil action against any person or entity that submits a petition to the Food and Drug Administration (FDA) with respect to certain pending prescription drug applications that is objectively baseless and that was submitted with the intent to use the FDA’s review process to delay approval of the application. In any civil action initiated under the bill, the FTC would face the burden of demonstrating that a petition was impermissible unless the FDA determined that it had been submitted with the primary purpose of delaying the approval of a covered application, the FDA referred the petition to the FTC in writing, and the petition was submitted as part of a series of covered petitions; in those cases, the burden of proof would shift to the person or entity who submitted the petition. The bill would allow the FTC to seek monetary penalties and other appropriate relief.
