Drugs

Naloxone Guidance Attempts to Ease Availability

FDA has made available an “immediately-in-effect guidance” entitled Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act (DSCSA) for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency. The document is intended to increase public availability of, and access to, naloxone, which is the go-to drug for reversing the effects of an opioid overdose.

“FDA understands that naloxone is being made available to underserved communities through entities such as harm reduction programs,” the guidance says, adding that it is aware of concerns that these programs are having difficulty acquiring naloxone. One factor hampering acquisition is the Drug Supply Chain Security Act (DSCSA) and its requirement for being an “authorized” trading partner.

To boost the availability of naloxone through harm reduction programs, the guidance clarifies the “exclusion and exemption under the DSCSA as they apply to the distribution of FDA-approved naloxone products indicated for the emergency treatment of opioid overdose to harm reduction programs during the opioid public health emergency.”

Many public health advocates have called on FDA to make naloxone available over the counter. However, FDA’s guidance clarifies that the “prescription status of drug products and prescription requirements under federal and state law are beyond the scope of this guidance. Therefore, this guidance does not address the prescription-only status of FDA-approved naloxone products.”

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