After years of concern, the Food and Drug Administration issued draft guidelines that are designed to limit the use of citizen petitions to delay approval of generic drugs or biosimilars. The move comes after long-standing complaints by agency officials that many petitions generally do not raise valid scientific concerns and appear to have been filed solely to delay rival medicines.
The new guidance indicates that the agency would highlight any improper use of these petitions in its annual reports filed with to Congress and may refer purportedly inappropriate petitions to the Federal Trade Commission, which could then pursue violations of antitrust laws.
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