An FDA citizen petition is a process provided by the

United States Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...

(FDA) for individuals and community organizations to make requests to the FDA for changes to health policy. It is described in

Title 21 of the Code of Federal Regulations Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (O ...

(21 CFR Part 10). Pharmaceutical companies routinely use FDA citizen petitions to delay the entry of generic drugs into the United States marketplace. Companies use this to counter the parts of the

Drug Price Competition and Patent Term Restoration Act The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal law that encourages the manufacture of generic drugs by the pharmaceutical industry and es ...

, which make generic drugs more available. In 2016,

Pharmaceutical Research and Manufacturers of America Pharmaceutical Research and Manufacturers of America (PhRMA, pronounced ), formerly known as the Pharmaceutical Manufacturers Association, is a trade group representing companies in the pharmaceutical industry in the United States. Founded in 195 ...

requested various changes to the FDA petition process, which the FDA declined. In November 2016, the FDA updated the citizen petition process. Most citizen petitions are filed by drug companies against competing drug companies. Innovator companies may also present arguments to the FDA that the Abbreviated New Drug Application (ANDA) should not be accepted by filing a "citizen petition" with the FDA. 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.” 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. 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. In 2014, the FDA issued guidance to industry about submitting citizen petitions and how it would consider them.

References

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External links

Code of Federal Regulations Title 21, Sec. 10.30 Citizen petition
the text of the law Processes from the Code of Federal Regulations Food and Drug Administration