Drugs

Put RLD Petition Designations in GDUFA 2: Lawyer

Attorney Kurt Karst (Hyman, Phelps & McNamara) says that while the GDUFA 2 reauthorization negotiations are likely to yield only small changes and refinements, one thing he would like to see included is a deadline for FDA to rule on a citizen petition asking the agency to designate a drug as a reference-listed drug (RLD). Writing in his firm’s FDA Law Blog, Karst says such a change is important to ANDA and 505(b)(2) NDA applicants.

He notes that ANDA applications can’t be submitted unless the drug in question has been listed in the Orange Book as a reference-listed drug. Thus, agency delays in responding to citizen petitions for a designation leave the drug sponsor in limbo. Over the years, he says, FDA has received and responded to scores of petitions asking that it assign RLD status to various NDA and ANDA approved drug products. “FDA only very rarely denies a citizen petition requesting RLD designation,” Karst writes. “Given the rarity of denials, and what we think should be a relatively perfunctory process, it’s surprising to us that FDA takes sooo long to issue a decision on an RLD designation citizen petition request…. Some have been pending for years with nothing more than the boilerplate interim response required within 180 days after FDA receives a petition.”

The post notes that other types of petitions are subject to statutory deadlines. If RLD petitions were subject to a statutory deadline or a GDUFA 2 performance goal, he concludes, perhaps 90% of petitions reviewed and acted on within 60 or 90 days of receipt, there probably would be better results and ANDA applicants would be in a better position to plan and seek approval.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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