Drugs

House Committee Asks Opioid Briefing

Bipartisan leaders of the House Energy and Commerce Committee are asking for information from FDA on two agency actions relating to opioids. In a 6/25 letter to agency acting commissioner Ned Sharpless, the legislators raise questions about (1) the agency’s management of safeguards against high-risk patients being prescribed certain types pf fentanyl products made by Insys Therapeutics and other companies that still resulted in inappropriate prescribing, according to researchers; and (2) the FDA 2001 decision that expanded the label for Purdue’s Oxycontin to cover chronic, long-term pain.

The letter covers research and news items that triggered committee members’ concerns and requests an agency briefing to address:

· the FDA assessment of its management of risk evaluation and mitigation strategies for transmucosal immediate-relief fentanyl products and any recommended changes to make the program more effective;
the status of FDA implementation of recommendations in a 2013 HHS Office of Inspector General report on REMS effectiveness;
lessons learned from the 2001 Oxycontin labeling decision;
what FDA would now do differently on the Oxycontin labeling decision in addition to requiring effectiveness research as required in the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act;
when drug manufacturers were notified of an agency requirement that they study the efficacy and sensitivity of opioid users to pain and when the research will be completed; and
what additional steps the agency is taking to address and curb opioid and fentanyl abuse.

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