Free Drug Program Avoids Sanctions Under AKS
April 6, 2021 | Ada (Kozicz) Janocinska | FDA | Fraud and Abuse | Legislation and Public Policy | Medicare and Medicaid | Pharmaceuticals
In a recent advisory opinion, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) determined not to impose sanctions under the federal Anti-Kickback Statute (AKS) on a drug manufacturer program that offers a free drug to certain eligible patients. The manufacturer uses personalized medicine technology to make the drug from the …
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Shapiro Quoted on CBD Warning Letters in Vitamin Retailer
March 31, 2021 | Rivkin Rounds Staff | Cannabis | FDA | Legislation and Public Policy
A March 26 article in Vitamin Retailer, “FDA Warns Selling of Topical CBD Products Violates FD&C Act,” discussed the two warning letters recently issued by the U.S. Food and Drug Administration (FDA) to two companies for selling topical pain relief products containing CBD. The FDA claims that the sale of the products violates the Federal …
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FDA Warns that Topical Pain-Relief Products Containing CBD Violate FD&C Act
March 25, 2021 | Steven Shapiro | Marc S. Ullman | Cannabis | FDA | Legislation and Public Policy | Pharmaceuticals
This week, the U.S. Food and Drug Administration (FDA) issued Warning Letters that effectively declare that the presence of cannabidiol (CBD) as an inactive ingredient in topical over-the-counter (OTC) drug products is a  violation of the federal Food, Drug, and Cosmetic Act (FD&C Act). In a news release issued on March 22, 2021 the FDA announced that …
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Psychedelic Therapy Training Program Launched
October 19, 2020 | Rivkin Rounds Staff | Behavioral Health | FDA | Hospitals | Pharmaceuticals
Mind Medicine, Inc. (MindMed) and NYU Langone Medical Center (NYU) recently announced a joint project to launch a clinical training program focused on psychedelic-assisted therapies and psychedelic-inspired medicines. MindMed, a psychedelic drug startup, is studying the use of hallucinogenic drugs in the treatment of mental health conditions. This venture is the first step in establishing a …
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FDA Announces Digital Health Center of Excellence
October 7, 2020 | Cassandra Rivais DiNova | Electronic Health Records | FDA | Home Health | Legislation and Public Policy | Medical Devices and Wearables | Telehealth
On September 22, the U.S. Food and Drug Administration (FDA) announced the launch of its Digital Health Center of Excellence within the Center for Devices and Radiological Health. The FDA called this an important step toward its goal of advancing digital health technology, including mobile health (mHealth), health information technology, wearable devices, telehealth, and personalized …
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Ullman to be Panelist at COVID-19 Webinar for Practitioners on 10/7
October 6, 2020 | Rivkin Rounds Staff | COVID-19 | FDA | Fraud and Abuse | Legislation and Public Policy
In the words of the American Association of Naturopathic Physicians: “Since March, the Federal Trade Commission (FTC) and Food and Drug Administration (FDA) have been aggressive in policing online language about COVID—and with good reason! Fraudulent products and false claims abound.” In one such instance, discussed here, the U.S. Department of Justice charged a physician with …
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DOJ Charges California Physician with COVID-19 Fraud
April 21, 2020 | Marc S. Ullman | COVID-19 | FDA | Fraud and Abuse | Litigation | Pharmaceuticals
On April 16, the United States Attorney’s Office for the Southern District of California charged Dr. Jennings Ryan Staley, a licensed physician and the operator of Skinny Beach Med Spa in San Diego, with mail fraud in connection with his offer to sell “COVID-19 treatment packs” to patients and the general public. Emails sent by Dr. Staley …
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FDA Takes Steps to Speed COVID-19 Imports
April 6, 2020 | Marc S. Ullman | COVID-19 | FDA
On April 3, the U.S. Food and Drug Administration (FDA) posted a notice that it has created a special email address in order to assist importers who are experiencing delays bringing COVID-19-related supplies into the U.S. According to the notice, the primary reason for the delays is confusion relating to the difference between personal and commercial …
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CARES Act: Diagnostic Testing and Laboratory-Related Provisions
March 26, 2020 | Geoffrey R. Kaiser | COVID-19 | FDA | Legislation and Public Policy | Medicare and Medicaid | Private Insurers
Several of the provisions in the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) passed by the Senate on March 25 relate to laboratory diagnostic testing for the COVID-19 virus. Within Division A of the CARES Act, titled “Keeping Workers Paid and Employed, Health Care System Enhancements, and Economic Stabilization,” there are four sections …
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FDA Reassures on Safety of U.S. Food Supply
March 26, 2020 | Marc S. Ullman | COVID-19 | FDA | Legislation and Public Policy
Amidst concerns over the rapid spread of COVID-19, on March 24, U.S. Food and Drug Administration (FDA) Deputy Commissioner for Food Policy and Response Frank Yiannas issued a statement advising Americans that “there is no evidence of human or animal food or food packaging being associated with transmission of the coronavirus that causes COVID-19.” Yiannas noted …
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