This bill amends federal drug approval laws to crack down on "citizen petitions"—formal requests that companies can file with the FDA to delay or block approval of generic and biosimilar drugs. The legislation establishes a 180-day deadline for submitting these petitions after a company learns relevant information, and requires that petitions be filed before any related court cases. The bill gives the FDA specific factors to consider when determining if a petition is being used primarily to delay competition, including whether multiple similar petitions are filed in quick succession, whether petitions are submitted without supporting data, or whether they ask for unnecessarily strict testing standards. The changes are designed to prevent brand-name drug manufacturers from using the petition process as a stalling tactic to keep cheaper generic alternatives off the market longer. The bill contains no specific funding allocations or implementation timeline beyond the 180-day submission requirement.
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