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Q&A with FDA

December 10, 2023by Todd Eury
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“Q&A with FDA” provides engaging conversation and discussion about the latest regulatory topics. In this podcast series, FDA’s Division of Drug Information will answer some of the most commonly asked questions received by FDA. Perhaps you have had the same questions but never asked.

CURE ID is an internet-based repository that allows the global community to report novel uses of existing drugs for difficult-to-treat diseases through a website, a smartphone, or other mobile device. In this episode, FDA’s Division of Drug Information interviews Ms. Heather Stone, FDA’s health science policy analyst in the FDA’s Office of Medical Policy, and Dr. Marco Schito, Executive Director of the Critical Path Institute’s CURE Drug Repurposing Collaboratory, or CDRC to discuss the benefits and future of CURE ID.

 

In this episode of Q&A with FDA, we hear from Dr. Marta Sokolowska, Deputy Center Director for Substance Use and Behavioral Health in FDA’s Center for Drug Evaluation and Research, discuss the Agency’s vision as it relates to encouraging harm reduction, including expanding availability and access to lifesaving overdose reversal products. Dr. Sokolowska delves into the impacts of the recent approvals of nonprescription naloxone nasal spray as well as prescription nalmefene nasal spray, another medication for opioid overdose.

 

In this podcast series, we answer some of the most frequently asked questions we’ve received from the public.

 

 

According to the National Association of Boards of Pharmacy, for the past 10 years, industry experts have consistently estimated that, at any given time, there are between 30,000 and 40,000 active illegal online pharmacies.

Today, we are joined by Commander Lysette Deshields, an FDA officer in the United States Public Health Service Commissioned Corps. CDR Deshields is a Regulatory Officer in the Supply Chain Security Branch in the Office of Drug Security, Integrity and Response, Office of Compliance within the FDA’s Center for Drug Evaluation and Research. She will be discussing FDA’s BeSafeRx campaign, a national initiative to educate consumers and health care professionals about the potential dangers of buying medicine from unsafe online pharmacies, along with identifying safe online pharmacies so that consumers can make more informed decisions when purchasing prescription medicine online, and tools that healthcare professionals can use to guide patients.

The rates of alcohol use disorder increased significantly since the onset of COVID-19, making this a major public health issue, though it’s not discussed as frequently as opioid overdoses. Over 140,000 Americans die from the effects of alcohol in an average year (more than from drug overdoses). Ten percent of Americans over the age of 12 have Alcohol Use Disorder. And according to the 2023 Alcohol Abuse Statistics, 60% of Americans increased their alcohol consumption during COVID-19 lockdowns.

In this podcast, we are joined by Dr. Iilun Murphy, Director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research (CDER), and returning is Dr. Marta Sokolowska, CDER’s Deputy Center Director for Substance Use and Behavioral Health to discuss the recent first generic approval to Vivitrol, a one-month extended-release injectable naltrexone that is used to help people recovering from opioid or alcohol dependence.