Drugs

Maloney Introduces Opioid Review Legislation

Rep. Sean Maloney (D-NY) has introduced the Opioid Review Modernization Act of 2016 (H.R. 4976) to require FDA to seek advisory committee recommendations before approving opioids without abuse-deterrent properties. The bill also would create a strategy for educating doctors on the potential harms in overprescribing opioids.

“No single strategy can solve this problem,” Maloney said in a statement. “We need a comprehensive approach that builds on proven methods and innovative solutions to end the overprescribing of opioids, get drugs off our streets, and expand prevention and treatment efforts. This bipartisan legislation is another tool in our tool belt to combat the opioid epidemic by providing incentives for pharmaceutical companies to use anti-abuse technologies and create a plan to educate our well-meaning doctors about the potential dangers of prescription opioids.”

The bill would require FDA to establish an advisory committee to evaluate new drugs that don’t contain abuse-deterrent properties. The committee also would solicit outside input and would provide for a period for public comments. Drug companies that choose to include abuse-deterrent mechanisms in new medicines would have the option to bypass the committee, Maloney explains. The bill also would require the agency to develop a suggested curriculum for doctors who prescribe opioids as part of the Risk Evaluation and Mitigation Strategy. Maloney says that currently no comprehensive strategy exists to ensure that all doctors are aware of the potential for abuse inherent in opioid-based medicines.

The bill is co-sponsored by Rep. Leonard Lance (R-NJ).

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