Drugs

FDA Should Push Data Development, Dissemination: Exec

Astellas senior vice president Jeffrey Bloss says it’s “time to create a modernized regulatory framework that encourages the development and dissemination of accurate, data-driven information, including real-world evidence, to achieve high-quality, high-value patient care.” Writing in a sponsored opinion piece on The Hill online, Bloss says that real-world evidence allows for broader examination of information on the use of medicines. “We can learn new details about how a patient responds that can be incredibly meaningful over time,” he writes.

While payers want to know more about real-world patient experiences, Bloss says, and they seek healthcare economic data, “lingering ambiguities in related regulations serve as a deterrent not only for sharing such information, but for collecting it in the first place.”

He says that the 21^st Century Cures legislation that passed the House of Representatives last year took steps towards clarifying vague and ambiguous FDA regulations that Bloss says prevent companies from sharing certain accurate, data-driven information with payers and formulary committees to inform coverage and patient care

He references Pharmaceutical Research and Manufacturers of America comments on the 21^st Century Cures bill that supported an expansion of FDA’s ability to make decisions on the therapeutic benefits of a medicine based on real-world evidence. “They suggested and we agree that such a policy shift is overdue,” he concludes, “and could have a profound impact on the efficiency of drug development. It would appropriately reflect our technological capabilities and, most importantly, it would benefit patients seeking new options to battle disease.”

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