Drugs

HHS Needs Better Opioid Treatment Evaluation: GAO

The Government Accountability Office (GAO) says HHS should better assess the effectiveness of its efforts to expand medication-assisted treatment (MAT) for opioid addiction. In a study report, GAO says HHS has implemented five key efforts since 2015 that focus on expanding access to MAT for opioid use disorders. There are four grant programs that focus on expanding MAT access in various settings, including rural primary practices and health centers, and regulatory changes that expand treatment capacity by increasing patient limits for buprenorphine prescribers and allowing nurse practitioners and physician assistants to prescribe buprenorphine.

HHS officials told GAO that as of 8/2017, they were finalizing plans to evaluate the HHS efforts to address the opioid epidemic. A contract to conduct an evaluation was awarded 9/2016, they said, and HHS is still working with the contractor to finalize the evaluation approach that will look at whether HHS’ efforts to address the opioid epidemic have been implemented as intended.

GAO recommended that HHS (1) establish performance measures with targets relating to expanding access to MAT, and (2) establish timeframes for evaluating its efforts to expand access to MAT. HHS concurred with both recommendations, it says.

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

Read more

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