Drugs

Consider Exploring EOP2 Loophole: Attorney

Attorney Josephine Torrente (Hyman, Phelps & McNamara) says FDA has drug sponsors at a disadvantage by refusing to hear appeals from an end-of-phase 2 (EOP2) disagreement over Phase 3 study parameters. Writing in her firm’s FDA Law Blog, Torrente says in 2015 the agency revised its 15-year-old formal dispute resolution request (FDRR) guidance to exclude EOP2 disagreements, such as dose, eligibility criteria, and endpoints, from the FDRR process.

The agency’s position, Torrente writes, is that advice communicated in meeting minutes and other correspondence is not a regulatory action and sponsors are not required to follow the advice.

“The practical truth, however, is that failure to follow the division’s recommendations for Phase 3 design puts the program at significant risk of failure even if the Phase 3 study is successful,” she says.

Torrente says that while the agency shows no signs of revising its policy, companies may benefit from considering a loophole that allows a special protocol assessment (SPA) no agreement letter to be appealed.

“While conventional wisdom says that one is most likely to submit a SPA if it is possible to achieve concurrence with FDA on the adequacy of study design,” Torrente writes, “who’s to say that one can’t submit a SPA request in order to confirm a lack of such concurrence, thereby opening up the route to FDRR.” She says that while this approach could delay the start of Phase 3 by 4-5 months, it could accelerate, or make possible, time to ultimate drug 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

Read more

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