Report: FDA's Resources Strained by Generic Rx Petitions

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By Bronwyn Mixter

Sept. 29 — The FDA is concerned that the effort required to respond to certain citizen petitions on generic drugs within the statutory deadline comes at the expense of completing other work, according to a report released Sept. 25 by the agency.

The Food and Drug Administration Amendments Act of 2007 (FDAAA) added Section 505(q) to the Federal Food, Drug, and Cosmetic Act (FFDCA), which specifies that the FDA must not delay the approval of a pending abbreviated new drug application (ANDA) for a generic or a 505(b)(2) application due to a citizen petition or a petition for stay of action (PSA), unless the agency determines that a delay is necessary to protect the public health. The 505(b)(2) process is an abbreviated pathway that allows the FDA to rely on data not developed by the applicant for approval of a new drug application.

The FDA Safety and Innovation Act (FDASIA) of 2012 amended Section 505(q) by shortening the FDA's deadline from 180 days to 150 days for responding to petitions subject to 505(q), and by expanding the scope of 505(q) to include biosimilar applications.

The agency is required to submit an annual report to Congress on 505(q) petitions and whether generic drug applications were delayed by the petitions.

Serial Petitions, FDA Resources 

In its report to Congress for fiscal year 2014, the FDA said it “continues to receive serial 505(q) petitions, frequently from the same petitioner, about the same specific drug or class of drugs, sometimes requiring several separate responses about different issues regarding the same product.”

Responding to the serial petitions requires substantial FDA resources, the report said.

“The enactment of FDASIA has increased the strain on agency resources by significantly shortening the time frame for responding to 505(q) petitions by 30 days,” the report said. “The shortened time frame affords FDA even less time to evaluate the issues raised in the petitions and to provide a response that articulates the scientific and legal reasoning supporting the agency's decision. As a result, FDA has needed to direct resources away from other important initiatives to attempt to comply with the new shorter deadline.”

Number of Responses 

During fiscal year 2008 through FY 2014, the FDA received a total of 160 petitions subject to Section 505(q), the report said. Over this seven-year period, the FDA responded to all but nine of the petitions within the statutory time frame.

“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,” the report said.

For the 505(q) petitions that were resolved during FY 2008 through FY 2014, 98 (about 66 percent) were denied. Another 39 petitions (about 26 percent) were denied in part or granted in part and only eight petitions (about 5 percent) were granted.

Four petitions (about 3 percent) were voluntarily withdrawn by the petitioner, the report said.

Blocking Generic Competition 

The report said it is difficult to determine whether Section 505(q) is discouraging the filing of citizen petitions aimed at blocking generic competition.

The FDA said that in many instances, that statutory deadline for responding to a 505(q) petition occurs before any ANDAs or 505(b)(2) applications are ready for approval. In those cases, a petition answered within the statutory deadline doesn't delay approval of a pending application, the agency said.

From FY 2008 through FY 2014, six petitions resulted in a delay in approving a total of seven ANDAs, the report said. The six petitions represent 4 percent of all 505(q) petitions received over this period.

The report also said that over the seven-year period, one petition resulted in a delay in approving one 505(b)(2) application and this petition represents 0.7 percent of all 505(q) petitions received during this period.

The FDA hadn't received any 505(q) petitions regarding biosimilar applications during this time.

To contact the reporter on this story: Bronwyn Mixter in Washington at

To contact the editor responsible for this story: Brian Broderick at

The report is at


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