Citizen petitions and generic drug approval

In fiscal 2023, FDA received four citizen petitions of the kind that can stand in the way of a pending generic approval, according to the agency's sixteenth annual report to Congress¹ on the subject. In fiscal 2009 it received 31, according to an earlier report in the same series⁴.

A citizen petition is an open door. Anyone can ask FDA in writing to take, change or refrain from an action. Some petitions target a competitor's pending generic. FDA has said repeatedly that some of those are filed mainly to delay competition and do not raise valid scientific issues. In 2007, Congress added section 505(q) to the drug law to limit how such petitions can hold up approvals, and required FDA to report every year on whether any had.

Sixteen of those reports have been published. The ones GxRadar reviewed show that FDA has rarely delayed an approval because of a petition, that the number of petitions has fallen sharply, a decline FDA partly credits to a 2019 guidance, and that the agency still considers the law a drain on its staff.

What section 505(q) requires

Section 914 of the Food and Drug Administration Amendments Act, enacted Sept. 27, 2007, created the provision, according to FDA's first report under it⁵. It applies to petitions asking FDA to act on a pending generic application (an ANDA), a 505(b)(2) application, or, since 2012, an application for a biosimilar. The core rule, now codified at 21 U.S.C. 355(q)⁹, is that FDA "shall not delay approval of a pending application" because of such a request unless the request is a formal petition and FDA "determines, upon reviewing the petition, that a delay is necessary to protect the public health."

A clock comes with it. FDA must take final action on a 505(q) petition within 150 days and "shall not extend such period for any reason." The original 2007 deadline was 180 days. FDA's 2019 guidance on these petitions⁸ explains that the Food and Drug Administration Safety and Innovation Act of 2012 shortened it to 150 days and extended the provision to biosimilar applications.

Congress gave FDA one more tool. If the agency finds a petition was filed "with the primary purpose of delaying the approval of an application" and the petition does not on its face raise valid scientific or regulatory issues, it may deny the petition at any point.

Each annual report must give four figures: generic, 505(b)(2) and biosimilar approvals in the fiscal year; how many were delayed by 505(q) petitions; by how many days; and how many 505(q) petitions FDA received.

What FDA has reported to Congress

GxRadar read the three reports now posted on CDER's reports-to-Congress page⁷, covering fiscal 2021 to 2023, and the first three in the series, for fiscal 2008⁵, 2009⁶ and 2010⁴, which are still on FDA's site. For reports from 2020 and earlier, the CDER page points readers to an archived copy of the site, and GxRadar could not retrieve the fiscal 2011 to 2020 editions from it. Those years are marked as not available in the table below.

Across the law's first three years, the fiscal 2010 report said, the number of approvals delayed by 505(q) petitions was low: four ANDAs and no 505(b)(2) applications. In fiscal 2010 alone, FDA approved 426 ANDAs. The fiscal 2016 entry has its own story. FDA's fiscal 2017 report listed one 505(b)(2) application delayed 28 days; CDER later posted a correction⁷ saying that delay actually happened in fiscal 2016, had already been reported, and that fiscal 2017 should have shown no delays.

None of the three most recent reports showed a delay. The fiscal 2021 report³ covered 679 ANDA approvals, the fiscal 2022 report² 722 and the fiscal 2023 report¹ 782, none held up by a 505(q) petition.

How petitions end

Most petitions lose. Of the 265 petitions FDA had resolved under section 505(q) through Sept. 30, 2023, according to the fiscal 2023 report¹, it denied 189, about 71 percent. It granted 10, about 4 percent. It granted part and denied part of 58, and eight were withdrawn. Resolutions per year have shrunk with the filings: 28 in fiscal 2017, eight in fiscal 2019 and three in fiscal 2023.

The reports for fiscal 2021 through 2023 name one petition that failed the delay test. According to the fiscal 2022 report², a petition received Nov. 8, 2021 (Docket No. FDA-2021-P-1211) "appeared to have been submitted for the primary purpose of delay" and failed to raise valid scientific or regulatory issues. FDA said so in its Dec. 15, 2021, response and referred the petition to the Federal Trade Commission. The fiscal 2021 and 2023 reports say FDA made no such finding in those years.

The 2019 guidance and the drop in filings

FDA's September 2019 guidance⁸ listed considerations it would weigh in deciding whether a petition was filed mainly to delay a competitor. No single factor decides a case, the guidance says, and the list is not exhaustive. Among them:

• a petition filed after an unreasonable wait, judged from when the petitioner knew or should have known the information it relies on
• serial petitions raising issues that could have been raised the first time
• a petition filed close to the first date a competitor could be approved, such as when a patent or exclusivity expires
• a petition on approval standards for a drug with a published product-specific guidance, from a petitioner that never commented on that guidance
• a petition asking that competitors meet testing or labeling standards stricter than FDA requires of the brand

FDA also said it would refer such petitions to the FTC and flag them in its reports to Congress. In its reports for fiscal 2021 through 2023, the agency named the guidance as a factor that "may have contributed" to the decline in filings, while adding that it is unclear whether the decline will continue.

What the delay count leaves out

A zero in the delay column means FDA did not hold an approval past the date it would otherwise have acted. It does not measure the staff time a petition takes. The fiscal 2023 report¹ says FDA met the statutory deadlines "in part by redirecting efforts that otherwise would have been directed to other work, including responding to other citizen petitions." FDA says the statute requires it to put 505(q) petitions ahead of other matters, such as petitions raising safety concerns, and it "remains concerned about the resources required" to meet the 150-day deadline.

Section 505(q) is also separate from other petitions that affect generics. A suitability petition, for example, asks FDA's permission to file a generic that differs from the brand in strength, dosage form or route. FDA's fiscal 2025 FDARA activities report¹⁰ shows 117 suitability petitions awaiting a substantive response, 67 of them for more than 180 days. Other tactics that can slow generic entry, such as patent litigation and restricted access to brand samples, are covered in our pieces on the Hatch-Waxman Act, Paragraph IV certifications and the CREATES Act.

As of early November 2026, the newest report listed on CDER's reports-to-Congress page was the sixteenth, covering fiscal 2023. The fiscal 2024 and 2025 reports will show whether the string of reports without a delay has continued through a period GxRadar covers in its look at generic approvals in 2025. Readers can follow generic approvals as they happen on GxRadar's approvals page, and the Office of Generic Drugs explainer covers how those reviews run.