After years of concern, the Food and Drug Administration issued a rule on Tuesday that limits the use of citizen petitions to delay approval of generic drugs or biosimilars. The move comes after repeated 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 rule, which goes into effect this coming January, comes after the FDA issued new guidelines five years ago that were intended to limit such petitions. Congress, however, requires the FDA to respond to most petitions within 150 days, but agency officials have complained this creates an unnecessary problem.
