The US Food and Drug Administration (FDA) on Thursday unveiled tweaks to its Manual of Policies and Procedures (MAPP) that explains new limits to when the agency prioritizes certain generic drug applications.
“This update aims to efficiently allocate limited agency resources to areas where priority review is most likely to meaningfully increase generic drug access and ensure fairness to applicants,” FDA said on the update.
One of the major changes, according to the updated MAPP, is that FDA will no longer automatically prioritize all abbreviated new drug applications (ANDAs) that contain a paragraph IV certification, are submitted on the first day that any valid paragraph IV-containing application for the drug in question is submitted and are received as substantially complete.
Chad Landmon, chair of the law firm Axinn’s intellectual property and FDA practice groups, told Focus: “It seems to me like the biggest impact of the MAPP change will be on those companies with Paragraph IV certifications where litigation has been filed and where there are others on the market. They now will not be eligible for priority review unless they can demonstrate that they would be eligible for final approval before the goal date, which will require some showing that the patents and 30-month stay will be cleared.”…