The US Food and Drug Administration (FDA) on Tuesday issued a revised draft guidance designed to allow for FDA to reject 505(q) petitions if the agency determines the primary purpose of the petition is to delay the approval of an abbreviated new drug application (ANDA).
“We believe this will provide an additional deterrent to pursuing these tactics,” FDA said.
The new approach to reviewing petitions would also help FDA focus its resources on addressing petitions that are most likely to present an obstacle to the availability of generic drugs.
“Once an application is submitted, the FDA has a goal date of making an approval decision on that application within 10 months, or, for some priority applications, within eight months. If a citizen petition is received while a product application is already under review, and if the goal date for that review falls within the next 150 days, the draft guidance states that the FDA would expect to respond to that petition within 150 days,” FDA said.
Under the section, “How Does FDA Determine if a Petition Would Delay Approval of an ANDA, 505(b)(2) Application, or 351(k) Application,” FDA explains issues that could implicate the public health include, for example, “(1) whether a proposed generic drug product is bioequivalent to the reference listed drug or (2) whether an indication can be safely omitted from the labeling because that indication is protected by a patent.”…