Pharmaceutical companies routinely use FDA citizen petitions to delay the entry of generic drugs into the United States marketplace.
[2] In November 2016, the FDA updated the citizen petition process.
Citizen petitions are part of the basic law governing everything the FDA does—at any time, any “interested person” can request that the FDA “issue, amend, or revoke a regulation or order,” or “take or refrain from taking any other form of administrative action.”[5] Originally, there was no deadline by which the FDA had to respond to citizen petitions filed to protest ANDAs, leading to significant delays in approving generics.
[5][6][7] In 2007, the law was amended to include a new section, Section 505(q), in the part of the federal code created by the Hatch-Waxman Act; this section said that the FDA could not delay approving an ANDA due to concerns raised in a citizen petition unless the delay was "necessary to protect public health issues"; it also mandated that the FDA needed to respond to a petition within 180 days—this was shortened to 150 days via a 2011 amendment.
[5][8] In 2014, the FDA issued guidance to industry about submitting citizen petitions and how it would consider them.