Drugs

Sharpless Credits FDA 2019 Opioid Actions

FDA acting commissioner Ned Sharpless says one of the agency’s focuses in 2019 has been to implement the Substance Use-Disorder that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) that passed 10/24/18. The bill gave the agency new authorities to advance efforts to combat the nation’s opioid crisis.

In a statement, he says the agency has taken steps to fulfill these elements of the law:

clarifying agency regulation of non-addictive pain products;
evidence-based opioid analgesic prescribing guidelines report;
strengthening FDA and U.S. Customs and Border Protection coordination and capacity;
restricting entrance of illicit drugs;
safety-enhancing packaging and disposal;
clarifying agency postmarket authorities; and
study on abuse-deterrent opioid formulations access barriers under Medicare.

Sharpless says FDA also is using authorities provided by the SUPPORT Act to promote development of drugs to treat pain that are not addictive. Draft guidances are being developed to address issues relating to development of such drugs, he 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

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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