Drugs

Trump Declares Opioid Crisis a ‘National Emergency’

President Donald Trump says he is declaring the opioid epidemic a national emergency, adding that his administration is drafting paperwork to make it official. The move follows a main recommendation in a 7/31 White House-commissioned interim report that was directed by governor Chris Christie. A final report will be issued this fall. Declaring a national emergency would help the administration get a handle on the crisis, according to the report, which added that about 142 Americans die from opioid abuse/misuse every day.

If Trump decides to adopt recommendations in the report as part of his action plan, FDA would play a role in helping curb excessive prescriptions of opioids. One of the top recommendations is to mandate prescriber education initiatives with the assistance of medical and dental schools across the country to enhance prevention efforts. The CDC and FDA should finalize, review and recommend national training standards working with the Accreditation Council for Continuing Medical Education (ACCME) to ensure training courses are coordinated with other federal agencies, professional societies, medical schools, and residency programs to avoid discrepancies, the report says. “The FDA should also work with the ACCME to develop data analytics to determine whether courses change practices, increase patient referrals to treatment, and methods to improve compliance consistent with opioid prescribing education.”

Other top recommendations include:

Provide federal funding and technical support to states to enhance interstate data sharing among state-based prescription drug monitoring programs to better track patient-specific prescription data and support regional law enforcement in cases of controlled substance diversion.
Better align, through regulation, patient privacy laws specific to addiction with the Health Insurance Portability and Accountability Act to ensure that information about substance use disorders be made available to medical professionals treating and prescribing medication to a patient.

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