Regulatory Gridlock by Citizen Petition

Filing citizen petitions with the FDA allows the public to raise concerns with the FDA and is often completely legitimate. However, brand name drug companies often file sham petitions with the obvious intent to slow the FDA’s generic approvals.

These “blocking petitions” force FDA to address the merits of every petition, requiring considerable time and draining FDA resources. A recent study found that the FDA denies 92% of these petitions, suggesting that an overwhelming majority of them are filed to delay, rather than for legitimate reasons.

“The study provides empirical evidence that the citizen petition process at the FDA has now become a key avenue for strategic behavior by pharmaceutical companies to delay entry of generic competition.”

For example, ViroPharma engaged in a delay campaign that involved filing 24 citizen petitions to stall the entry of a generic Vancocin competitor. The FTC brought suit over this delay campaign.