Drugs

Senator Manchin Seeks 3 Opioid Policy Changes

Senator Joe Manchin (D-WV) has called on FDA to adopt three policy changes through its Opioid Policy Steering Committee to reduce unnecessary and dangerous opioid medications. In a 12/6 letter to FDA commissioner Scott Gottlieb, Manchin offered support for the steering committee. He noted that in the past he had been “very critical of the role that the FDA has played in this epidemic, but I have been heartened to see the changes that the agency has been making to take responsibility for the public health impact of these deadly drugs.”

Manchin’s first policy change recommendation is that FDA should require mandatory and continuing education for every healthcare provider who prescribes opioids. He said too many medical professionals have received inadequate training on opioid dangers, addiction signs, and and alternatives to opioids for managing pain.

Second, Manchin said FDA should seek advisory committee guidance and review every opioid product that is currently on the market to determine if its risks outweigh the benefits. “Every opioid that an advisory committee determines is more dangerous than beneficial should be immediately removed from the market,” he said.

And lastly, for every new opioid medication approved, FDA should remove one or more older opioids from the market that have a history of abuse, Manchin wrote. “This market is saturated and we can currently treat everything from short-term, acute pain to excruciating cancer pain,” he said. “We simply do not need to increase the number of opioid medications on the market.”

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