Drugs

Reps. Want FDA to Address Estrogen Patch Shortages

Eight House Democrats are asking FDA to address estrogen patch shortages for menopause treatment. The seven — Reps. Debbie Dingell (D-MI), Deborah Ross (D-NC), Eleanor Holmes Norton (D-DC), Andrea Salinas (D-OR), Jesus Garcia (D-IL), Yvette Clark (D-NY), Rashida Tlaib (D-MI), and Emily Randall (D-WA) — wrote to FDA acting commissioner Kyle Diamantas that the shortage is “straining the ability of doctors to provide resources that can be life-changing for women battling the symptoms of menopause….”

The letter says FDA has not included any of the products on its drug shortage lists. “Inclusion on the shortage list can help FDA mitigate supply issues, such as taking action to seek alternative suppliers and extend expiration dates for drugs, as appropriate,” the lawmakers wrote.

The eight asked for written responses to these questions:

FDA’s understanding of why providers and patients are having difficulty accessing estrogen patches;
what FDA is doing to understand and address the challenge of meeting increased demand for estrogen patches;
how FDA is working with manufacturers now to mitigate the shortage of estrogen patches and what future work is planned;
whether the agency expects alternatives to estrogen patches to also go into shortage as providers and patients make more use of them;
what flexibilities FDA can provide to help manufacturers increase their production of estrogen patches;
when the agency expects that the shortage of estrogen patches will be resolved; and
how agency reductions in force have affected the ability of CDER staff to maintain the drug shortage database.

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