FDA Insight: Episode 9 – Transcript
>> Anand Shah: Welcome back to another episode of FDA Insight. I'm Dr. Anand Shah, the deputy commissioner for Medical and Scientific Affairs here at the FDA. Thank you for joining us for another informative episode. This week, we'll be discussing health fraud especially as it relates to the COVID-19 pandemic. My guest today is Dr. Judy McMeekin, Associate Commissioner for Regulatory Affairs here at the FDA. Dr. McMeekin, welcome to FDA Insight.
>> Judith McMeekin: Thank you. Very glad to be here.
>> Anand Shah: Consumers might hear of websites with names implying they have coronavirus cures, stories on social media about cures for COVID-19, or see products being sold on online marketplaces that claim to cure COVID-19. Can you tell us about what steps FDA has taken to combat misinformation?
>> Judith McMeekin: Sure. We have launched the Operation Quack Hack where the FDA has sent more than 90 warning letters to sellers, more than 150 reports sent to online marketplaces, and more than 250 abuse complaints sent to domain registrars.
>> Anand Shah: Are there currently any vaccines that have been approved by the FDA to treat COVID-19?
>> Judith McMeekin: There are currently no vaccines to prevent or drugs to treat COVID-19 approved by the FDA. There are investigational COVID-19 vaccines and treatments being studied in clinical trials. These products are in the very early stages of development.
>> Anand Shah: So, Dr. McMeekin, anyone who says they have an approved cure or treatment, isn't telling the truth?
>> Judith McMeekin: Correct.
>> Anand Shah: And getting back to Operation Quack Hack, and I really like the name, what type of fraudulent products have been found so far?
>> Judith McMeekin: So, we've identified more than 700 fraudulent and unproven medical products related to COVID-19 including nasal sprays, rapid COVID-19 test kits, dietary supplements, and other foods, teas, essential oils, tinctures, and colloidal silver.
>> Anand Shah: Besides fraudulent products, what are common examples of COVID-19 health fraud that consumers should be aware of?
>> Judith McMeekin: Consumers should be aware of email phishing scams, government impersonators, contact tracing scams, even work from home fraud along with investment fraud, and coronavirus related charity scams that are occurring.
>> Anand Shah: How should consumers protect themselves and their family members from coronavirus fraud and pandemic scammers?
>> Judith McMeekin: I would encourage consumers to be cautious of websites and stores selling products that claim to prevent, treat, or cure COVID-19. Never reveal any type of personal or financial information in an email or respond to requests for it. Additionally, folks should check official sources on Twitter including the accounts of trusted news sites and their news reporters, and avoiding political operatives where possible. If a site claims to be an official government publication, consumers should check the URL to see if it ends in a .gov setting.
>> Anand Shah: In the experience of the agency, who is most vulnerable to COVID-19 scams?
>> Judith McMeekin: What we see is that older senior citizens. Those who are out of work and also those who are sick and scared.
>> Anand Shah: And how are we collaborating with other agencies right now to combat health fraud?
>> Judith McMeekin: Within the FDA, several parts of the agency are involved in combating health fraud. The Office of Criminal Investigations, the Office of Enforcement and Import Operations, and the Health Fraud Branch within the Office of Regulatory Affairs, all work collaboratively with colleagues in the FDA's medical product centers, and also the Office of Chief Counsel. FDA also works closely with other government agencies such as the Center for Disease Control, U.S. Customs and Border Protection, and also the U.S. Department of Justice.
>> Anand Shah: So, the FDA has been very busy over the past several months. Can you tell us about how the new communication initiatives at FDA are working right now?
>> Judith McMeekin: Well, first, there's this podcast where we're helping to inform consumers about the latest medical and scientific developments. So, thank you for starting this, Dr. Shah. And also, we have FDA risk communication strategic plan.
>> Anand Shah: And if our listeners suspect that a product might be fraudulent, what is the best way for them to report their findings to the FDA?
>> Judith McMeekin: Report fraudulent or unproven products to the agency using the MedWatch portal on the FDA website which is available in both English and in Spanish. The URL is at https://www.fda.gov/medwatch.
>> Anand Shah: Dr. McMeekin, this is really timely information. As we wrap up this episode of FDA Insight, I'd like to thank you for coming on today to talk about how we're working to keep Americans safe.
>> Judith McMeekin: Well, thank you for asking me to come on the show. I hope we were able to provide a little insight into what we do in FDA's Office of Regulatory Affairs.
>> Anand Shah: Of course. And to our listeners, we'll continue providing you that insight in plain language to help you understand the products that we regulate, the issues that we face, and the processes that we follow. We hope you enjoyed this episode of FDA Insight. Please subscribe on your favorite podcast app such as Apple Podcasts, Google Play, and others. Thanks for listening.
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