Drugs

Woodcock Plays Advisory Role at Patient Nonprofit

Former FDA principal deputy commissioner Janet Woodcock is playing an advisory role at the Haystack Project, the nonprofit group has confirmed on its Web site. The group says it is dedicated to ensuring patient access to treatment options for the rare and especially ultra-rare community. Formed in 2016, Haystack Project “brings together patient organizations representing extremely rare diseases to learn from each other and speak out about the systemic barriers to appropriate patient care for our community,” it says.

The nonprofit has posted a reprint of a 4/17 Pink Sheet article on Woodcock’s role and similar plans since she retired from FDA earlier this year after 37 years at the agency (see earlier story).

“I have always tried to help patients,” Woodcock told the Pink Sheet. “I don't plan in my retirement to really have much involvement in drug development. But I do want to help the nonprofit side. Particularly people with rare diseases suffer so much and drug development is so difficult for them. And so, you know I want to help in any way I can.”

Woodcock said she wants to help rare disease groups navigate the delicate balance of determining how to operate development programs to meet their unique circumstances without jeopardizing their ability to get to market. “My own belief is you cannot look people in the eye and say there's no way you'll ever have a therapy developed for you, except by accident or something, that just isn't right,” she said. “So, we have to find a way to help people especially with ultra-rare diseases. But it takes a lot of effort and creativity, but not too much creativity in the sense that you're not going to be successful getting through the regulatory process. So, I think it's that balance that I can help with.”

Science, not advocacy, will be her focus, Woodcock told the Pink Sheet. She has provided advice to several other patient-focused nonprofits that are tackling disease areas with few or no treatment options, she said.

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