Drugs

Petitions Increase Generic Approval Days: Study

ANDAs with citizen petitions had a significantly higher average number of approval days, according to a study by Auburn University researchers published online in Research in Social and Administrative Pharmacy. The article says the researchers looked at 289 ANDAs for 81 drugs submitted between the first quarter of 2008 and the third quarter of 2014.

Citizen petitions were submitted for 184 ANDAs in the study period. The number of approval days of ANDAs with and without petitions was 1,221.7 and 978.6 days respectively, the article says.

The authors note that while the citizen petition process has been an effective instrument in facilitating FDA safety actions, drug companies can use it as a tool to delay entry since delaying competition could be worth hundreds of millions of dollars in revenue.

The study says that in 2007 Congress attempted to mitigate the possible abuse of the citizen petition process by requiring that FDA respond to a petition relating to a generic drug within 150 days rather than 180 days. “FDA has been concerned about the submission of citizen petitions, which were intended primarily to delay the approvals of competing drugs, and about the time and resources required to meet the statutory deadline,” the authors say.

While an FDA report to Congress said that citizen petitions rarely delayed generic drug approvals, the authors say it was based on the statutory deadline and not on the actual number of generic drug approval days.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome