Drugs

FDA Gets New Opioid Fight Authorities

FDA commissioner Scott Gottlieb says the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, recently signed by the President, gives FDA new authorities “that we believe will meaningfully advance our efforts, and the agency will take immediate steps to implement this legislation in a way that achieves Congress’ and the President’s goals to reduce the scope of the crisis.” In a statement, Gottlieb says FDA’s work falls into four main areas: decreasing exposure to opioids as a way to prevent new addiction; advancing innovation in pain medicines that don’t have the same risk as opioids; developing and using better treatments to help those with opioid use disorder; and increasing enforcement and interdiction work aimed at illicit drugs such as fentanyl, especially in products shipped illegally through international mail facilities (IMFs).

“This legislation gives us important new tools to work more effectively across all four broad domains,” he says. Some of the new tools are:

improving efficiency in the IMFs, expanding the ability to conduct oversight work by detaining, refusing, and destroying unlabeled and undeclared imported products that are found to contain active ingredients or analogs of active ingredients that are FDA-approved drugs;
debarring those convicted of a felony involving illegal importation of drugs or engaging in a pattern of importing certain adulterated or misbranded drugs for commercial sale;
issuing a mandatory recall order for any controlled substance if there is a reasonable probability that the controlled substance would cause serious adverse health consequences or death;
taking additional steps to reduce exposure to opioids to lower the rate of new addiction;
allowing FDA to require certain packaging, such as unit dose blister packs, for opioids and other drugs that pose a risk of abuse or overdose;
authorizing FDA to require that opioids be dispensed with a mail-back pouch or other safe disposal option; and
helping FDA to advance its understanding of opioid pain medicines by clarifying its authority to require post-market studies on the efficacy of drugs over time under certain circumstances.

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