Although only one abbreviated new drug application (ANDA) and one 505(b)(2) application were delayed in 2015 because of citizen petitions, the US Food and Drug Administration (FDA) has reiterated its concerns that the petitions do not raise valid scientific issues and are only being used to delay the approval of competing products, according to the Thursday release of the FY 2015 report to Congress on approval delays from citizen petitions.
In 2015, FDA notes that it approved 492 ANDAs, 45 505(b)(2) applications, one biosimilar application, and received 15 505(q) petitions (a vehicle that stakeholders outside of the agency can use to ask FDA "to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action"). Of those 15 petitions, the approval of one ANDA was delayed because of two 505(q) petitions, and the approval of one 505(b)(2) application was delayed because of one other petition.
And though dealing with those petitions might seem like a meager amount of work in comparison to the approval work, FDA makes clear in its report that it has to redirect efforts that could have dealt with public health concerns, in order to address the petitions.
“FDA continues to be concerned that section 505(q) may not be discouraging the submission of petitions that are intended primarily to delay the approval of competing drug products and do not raise valid scientific issues,” the report says. “However, the statute requires FDA to prioritize these petitions above other matters, such as safety petitions, that do raise important public health concerns. Although FDA has generally met the statutory deadlines for 505(q) petitions, it did so in part by redirecting efforts that otherwise would have been directed to other work, including responding to other citizen petitions. FDA remains concerned about the resources required to respond to 505(q) petitions within the statutory deadline at the expense of completing the other work of the Agency.”
And as the chart below shows, FDA has approved less than one out of every 10 petitions it denied since 2008.
In the report’s conclusion, FDA once again says it “remains concerned about the resources required to respond to 505(q) petitions within the 150-day deadline at the expense of completing the other work of the Agency.”
And as the FDA Law Blog reported the last time FDA released such a report to Congress, it seems like the agency has been complaining about these petitions for years, and particularly since the 2012 FDA Safety and Innovation Act changed the 180-day response deadline to 150 days and made the law apply to biosimilar applications.
Eighth Annual Report on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2015