FDA vs Fraudulent COVID-19 Products

FDA vs Fraudulent COVID-19 Products

On March 2, The U.S. Food and Drug Administration (FDA) announced about the beginning of the ‘National Consumer Protection Week,’ to encourage consumers and health care providers to report websites and individuals suspected of selling fraudulent COVID-19 products (as well as unapproved and unauthorized products). Reports can be made by the public using a portal on the FDA website, which is available in both English and Spanish.

“The FDA is well-equipped to identify and thwart medical product scams. The Office of Regulatory Affairs’ Health Fraud Branch, the Office of Criminal Investigations (OCI), and the Office of Enforcement and Import Operations work collaboratively with colleagues in the FDA’s medical product centers, the FDA’s Office of Chief Counsel, and the HHS Office of Minority Health, as well as other government agencies such as U.S. Customs and Border Protection and the U.S. Department of Justice,” – said Judy McMeekin, Pharm. D., Associate Commissioner for Regulatory Affairs.

Fraudulent COVID-19 Producs And National Consumer Protection Week

Consumers should know the COVID-19 vaccines that the FDA has authorized under Emergency Use Authorization cannot be sold online. Legitimate COVID-19 vaccines are being distributed for free. Unfortunately, the agency is aware of reports of unauthorized websites and listings on online marketplaces purportedly offering COVID-19 vaccines for sale. When such online listings are found by or reported to the FDA, the agency notifies the online marketplaces, who can then remove the listings. We are also aware of emails sent to consumers featuring the FDA logo, advising consumers to call a phone number to schedule a vaccination. If consumers are contacted directly by someone who says they are from the FDA about a COVID-19 vaccine appointment, it is a scam.

The FDA’s dedicated COVID-19 Fraudulent Products Task Force continues to monitor the market, including online, for fraudulent COVID-19 products, and the Operation Quack Hack initiative continues to leverage agency expertise and advanced analytics, resulting in the removal of hundreds of unlawful products from the marketplace. To date, the agency has uncovered nearly 1,300 fraudulent products, sent more than 160 warning letters, issued more than 270 abuse complaints to domain registrars, and sent more than 290 requests to various marketplaces to remove listings for fraudulent COVID-19 products.

The united federal effort has enabled the agency to minimize the impact of fraud on consumers. For example, OCI agents, working with partner agencies, quickly investigated, charged, and obtained guilty pleas from a Georgia man and his company for selling misbranded drugs advertised to treat COVID-19.

“Like the snake-oil salesmen of old, the suspect in this case said his $19 “Immune Shot” could “LOWER your risk of COVID-19 by nearly 50%.”  The suspect targeted individuals aged 50 and older with sales pitches, including company website statements such as “The NEXT FIVE MINUTES could save your life,” “… Immune Shot could be the most important formula in the WORLD right now due to the new pandemic,” “Immune Shot is Not a Luxury, It is a Necessity Right Now,” “Point Blank, if YOU Leave, YOU are at Risk,” and “Is Your Life Worth $19? Seriously, Is It?”,” – saying in the report Judy McMeekin.

Quidel QuickVue At-Home COVID-19 Test

Besides this the FDA announced about an emergency use authorization (EUA) for the Quidel QuickVue At-Home COVID-19 Test, another antigen test where certain individuals can rapidly collect and test their sample at home, without needing to send a sample to a laboratory for analysis.

The QuickVue At-Home COVID-19 Test is authorized for prescription home use with self-collected anterior nasal (nares) swabs from individuals ages 14 and older or individuals ages 8 and older with swabs collected by an adult. The test is authorized for individuals suspected of COVID-19 by their healthcare provider within the first six days of symptom onset.

“The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The QuickVue At-Home COVID-19 Test is another example of the FDA working with test developers to bring important diagnostics to the public.”

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