FDA's emergency nod for convalescent plasma sparks questions of whether it's bowing to Trump

 

08/17/2020	08/14/2020	SilveryGuy	Center for Drug Evaluation and Research | CDER	Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
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08/18/2020	07/24/2020	East Coast Vapors, LLC d/b/a VapeScorpion.com	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
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08/18/2020	08/05/2020	Winter Gardens Quality Foods, Inc.	Division of Human and Animal Food Operations East II	Food Labeling/Misbranded
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Coronavirus (COVID-19) Update: Daily Roundup August 17, 2020

The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic: The FDA issued Yale School of Public Health an emergency use authorization (EUA) for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19. This molecular test is for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva collected without preservatives in a sterile container from individuals suspected of COVID-19 by their healthcare provider. SalivaDirect does not require any special type of swab or collection device – a saliva sample can be collected in any sterile container. It is also unique because it does not require a separate nucleic acid extraction step. This is significant because the extraction kits used for this step in other tests have been prone to shortages in the past. As part of the FDA’s effort to protect consumers, the agency issued a joint warning letter with the Federal Trade Commission to SilveryGuy, a company that participates in the Amazon Associates program, for selling fraudulent COVID-19 related products. As an Amazon associate, the company earns commissions by promoting the sale of Colloidal Silver products on the company’s website, with misleading claims that the product can mitigate, prevent, treat, diagnose, or cure COVID-19 in people. Currently, there are no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider. Testing updates: To date, the FDA has currently authorized 214 tests under EUAs; these include 175 molecular tests, 37 antibody tests, and 2 antigen tests.

Additional Resources: FAQs on Testing for SARS-CoV-2 Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)

Coronavirus outbreak: FDA flags accuracy problem with widely used coronavirus test

 

Live updates from Modern Healthcare on the coronavirus outbreak and how COVID-19 is affecting the healthcare industry.

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Regulators find toxic 1-propanol as well as methanol in some products.

Read in Ars Technica: https://apple.news/AnQKofJihTASJZY2fNrVaQg

Michael Bray Making The Most Of It August 14, 2020

https://pastthewire.com/michael-bray-making-the-most-of-it/ 

Domestic Rx, device supply chain a tall order

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AmerisourceBergen puts former PharMEDium Memphis facility and equipment up for sale

https://www.bizjournals.com/memphis/news/2020/08/13/fortune-500-company-puts-memphis-facility-for-sale.html 

Former Vance AFB Major Sentenced to Two Years in Federal Prison for Taking Kickbacks Involving Compounding Pharmacies. Major she gave military members pre-printed prescription pads and induced them to ask their doctors for specific compounded drugs. The Major admitted she then sent the prescriptions or caused them to be sent to specific pharmacies.

 Department of Justice

U.S. Attorney’s Office

Western District of Oklahoma

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FOR IMMEDIATE RELEASE

Monday, August 10, 2020

Former Vance AFB Major Sentenced to Two Years in Federal Prison for Taking Kickbacks Involving Compounding Pharmacies

OKLAHOMA CITY – ROMEATRIUS MOSS, 40, a nurse and former Air Force Major stationed at Vance Air Force Base in Enid, Oklahoma, was sentenced today to serve 24 months in prison for health care fraud in which she accepted kickbacks for referring TRICARE beneficiaries to pharmacies furnishing compounded drugs, announced U.S. Attorney Timothy J. Downing.  Moss was also ordered to pay restitution in the amount of $622,459.00.

According to a felony information filed on September 30, 2019, Moss solicited and received $73,823.06 in return for referring prescriptions for members of the U.S. military to compounding pharmacies that were reimbursed by TRICARE, a health insurance program for military members.  Because of resulting cost increases and infringement on patient choice, it is a crime to solicit or receive payments for referrals to health care providers for an item or service that could be paid, in whole or in part, by a federal health care program.

Moss pleaded guilty on October 15, 2019, before U.S. District Judge Patrick R. Wyrick.  She admitted that while she was employed in the medical unit at Vance AFB, she gave military members pre-printed prescription pads and induced them to ask their doctors for specific compounded drugs.  Moss admitted she then sent the prescriptions or caused them to be sent to specific pharmacies.  Moss admitted she was paid a kickback that was a percentage of the gross reimbursement the pharmacies received from TRICARE for filling the prescriptions.

Today, Judge Wyrick sentenced Moss to 24 months in the custody of the Bureau of Prisons, followed by three years of supervised release.  Judge Wyrick also ordered Moss to pay restitution to TRICARE in the amount of $622,459.00, the total amount of kickbacks she received in the referral scheme.  She was also ordered to forfeit her residence in Enid.

The case is the result of an investigation by the Defense Criminal Investigative Service, the Air Force’s Office of Special Investigations, and the Federal Bureau of Investigation–Oklahoma City Division.  Assistant U.S. Attorneys Jessica Perry and Amanda Maxfield Green prosecuted the case.

Reference is made to court filings for further information.  To download a photo of U.S. Attorney Downing, click here.

Topic(s): 

Health Care Fraud

Component(s): 

USAO - Oklahoma, Western