Drugs

Praise for Biosim User Fee Agreement

Pharmaceutical Research and Manufacturers of America says the reauthorization of the Biosimilar User Fee Act for FY 2018-2022 (BsUFA 2) “provides the resources and support needed for FDA to achieve its core mission of protecting and promoting public health.” The association says the reauthorization agreement will continue to build on the success of the agency’s biosimilar review program through new review enhancements that will help provide more predictable and timely access to biosimilar products. It also acknowledges the inclusion of other regulatory enhancements that it says will result in increased biopharmaceutical competition in the marketplace.

The Generic Pharmaceutical Association’s Biosimilar Council comments that the agreement will strengthen the biosimilars program and will specifically address the council’s key goals in the negotiations: additional staff, finalization of outstanding policy guidance, increased communication with applicants, and biosimilars public education. It notes that fewer biosimilars are approved today than originally projected and that BsUFA 2 is designed to reverse this outcome.

Finally, Boehringer Ingelheim says it welcomes the changes to the biosimilar review cycle laid out in the commitment letter, including the addition of 60 days to the review timeline, which gives FDA more time for review and should facilitate additional communication opportunities between FDA review teams and biosimilar sponsors. The company letter also discusses specific commitments it believes will meaningfully contribute to enhanced transparency, efficiency, and predictability.

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