FDA Raises Issue of Citizen Petitions

In August, the FDA noted its concerns that citizen petitions do not raise valid scientific issues and are used to delay the approval of competing products. This comes from the FY 2015 report to Congress on approval delays from citizen petitions. This comes after only one abbreviated new drug application (ANDA) and one 505(b)(2) application were delayed in 2015 because of citizen petitions.

Report to Congress

Under section 505(q)(3) of the FD&C Act, FDA is required to submit an annual report to Congress that includes the following information:

• The number of abbreviated new drug applications (ANDAs), 505(b)(2) applications, and biosimilar biological product applications approved during the reporting period;
• The number of such applications that were delayed by 505(q) petitions;
• The number of days by which the applications were delayed; and
• The number of 505(q) petitions that were submitted during the reporting period.

During the fiscal year (FY) 2015 reporting period, FDA approved 492 ANDAs, 45 505(b)(2) applications, and 1 biosimilar biological product application. No approvals for biosimilar biological product applications were delayed because of a 505(q) petition in this reporting period. 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 petition. During FY 2015, FDA received 15 of such petitions.

In the report, FDA’s analysis explains the agency’s concern that many citizen petitions are intended primarily to delay the approval of competing drug products and do not raise valid scientific issues. 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, 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 petitions within the statutory deadline at the expense of completing other important public health tasks.

Major policy issue?

As reported by Ed Silverman at Stat, the FDA concerns mirror an analysis coauthored by Michael Carrier, a Rutgers University School of Law professor who specializes in intellectual property. The analysis found that brand-name drug makers filed 92 percent of such citizen petitions between 2011 and 2015, although the FDA denied more than 9 out of every 10 petitions.

“Citizen petitions represent a hidden tool in (the brand-name drug maker’s) toolkit of entry-delaying activity, all to the detriment of consumers forced to pay high drug prices,” the paper concludes. “And in defiance of Congress’s attempt to limit abuse, citizen petitions play an increasingly important role in delaying generic competition.”

Tables from report

FDA data from the report was published as follows:

Table 1

Percentage of 505(q) Petitions Received

During Fiscal Years 2008-2015

FY Received	# of Petitions	# of 505(q) petitions	Percentage of petitions that were 505(q) petitions 27%
2008	78	21
2009	81	31	38%
2010	76	20	26%
2011	96	20	21%
2012	84	25	30%
2013	92	15	16%
2014	102	28	27%
2015	74	15	20%

Table 2

Outcomes of 505(q) Petitions

Resolved During Fiscal Years 2008-2015

	FY Resolved	Denied	Granted	Denied/ Granted in Part	Withdrawn	Total# of Determinations
Fiscal Year	2008	10	1	3	0	14
	2009	16	2	6	0	24
	2010	16	2	6	0	24
	2011	10	1	9	2	22
	2012	10	1	2	0	13
	2013	21	1	5	0	27
	2014	15	0	8	2	25
	2015	16	0	2	0	18
	Total	114	8	41	4	167

Outcomes:

• Denied: FDA denied the petition’s This includes instances where FDA issued a denial without comment on the substance of one or more of the requests.

• Granted: FDA granted the petition’s

• Denied in Part/Granted in Part: FDA denied some of the petition’s requests and granted others. This includes instances where FDA denied one or more of the requests without comment on the substance of the

• Withdrawn: The petitioner withdrew the

Table 3

Petitions Resulting in Approval Delays

During Fiscal Years 2008-2015

	FY	# of Petitions	# of Delayed Approvals
Fiscal Year	2011	1	1  ANDA
	2012	0	0
	2013	1	2 ANDAs
	2014	1	I   505(b)(2)
	2015	3	1  505(b)(2) and 1  ANDA
	Total	9	10

FDA’s conclusion

In FDA’s concluding language to Congress, it reiterated its concern that current law may not discourage citizen petitions that are intended primarily to delay the approval of competing drug products and do not raise valid scientific issues. The statute requires FDA to prioritize these petitions above other matters, such as safety petitions, that do raise important public health concerns. As a result, FDA remains concerned about the resources required to respond to petitions within the 150-day deadline at the expense of completing the other work of the Agency.