The FDA reported to Congress that pharmaceutical companies owning branded drugs may be filing 505(q) petitions for reconsideration (aka “citizen petitions”) to delay approval of generic versions of their drugs. The agency expressed concern that the need for it to respond to bogus petitions delays its ability to perform other necessary regulatory work.
The process was designed to encourage petitions raising scientifically valid issues or legitimately requesting warning labels, while discouraging abusive filings intended solely to delay. The agency is concerned, however, that drug companies have found a way to use them for delay purposes. The “FDA remains concerned,” the report stated, “about the resources required to respond to 505(q) petitions within the statutory deadline at the expense of completing the other work of the agency.”
The FDA told Congress that it would continue to monitor petition filings.