FDA Raises Concerns With 505(q) Petitions

Regulatory NewsRegulatory News | 08 February 2019 |  By 

In a report to Congress, the US Food and Drug Administration (FDA) took issue with a certain statute that requires FDA to prioritize petitions seeking to delay product approvals above other safety petitions that raise public health concerns.

“FDA continues to be concerned that section 505(q) does not discourage the submission of petitions that are intended primarily to delay the approval of competing drug products and do not raise valid scientific issues,” the agency said.

505(q) petitions are those that request FDA take action on a pending abbreviated new drug application (ANDA) or 505(b)(2) application.

During the most recent reporting period, fiscal year 2017, FDA said it received 25 505(q) petitions and no approvals for 351(k) applications or abbreviated new drug applications (ANDAs) were delayed because of a 505(q) petition. But the report notes the approval of one 505(b)(2) application was delayed because of a 505(q) petition.

“FDA was concerned that if it approved the 505(b)(2) application before resolving the issues raised in the petition and later concluded that one or more of the arguments against approval were meritorious, then the presence on the market of a drug product that did not meet the requirements for approval could negatively affect public health. Thus, FDA delayed approval of the 505(b)(2) application for 28 days to complete an analysis of the issues raised in the petition,” the agency said.

In total, since FY 2008, 182 petitions have been resolved under section 505(q) and just 10 have been granted. 141 of the petitions (about 67%) were denied and another 53 petitions (about 25%) have been denied in part and granted in part.

“FDA remains concerned about the resources required to respond to 505(q) petitions within the statutory deadline [of 150 days] at the expense of completing the other work of the Agency,” the report notes.

FDA last October issued a revised draft guidance designed to allow the agency to reject 505(q) petitions if the agency determines the primary purpose of the petition is to delay an approval.

Report to Congress


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