Thursday, December 17, 2020

 

FDA Warns Consumers to Avoid Certain Male Enhancement and Weight Loss Products Sold Through Amazon, eBay and Other Retailers Due to Hidden, Potentially Dangerous Drug Ingredients

Agency Urges Online Marketplaces, Other Websites and Retailers to Stop Selling These Male Enhancement and Weight Loss Products to American Consumers


The U.S. Food and Drug Administration is warning consumers not to use nearly 50 male enhancement or weight loss products that have been found to contain hidden ingredients and may pose a significant health risk. The FDA purchased these products on Amazon and eBay and agency testing found that the products contain active pharmaceutical ingredients not listed on their labels, including some with ingredients found in prescription drugs. These products may cause potentially serious side effects and may interact with medications or dietary supplements a consumer is taking.

Despite FDA consumer warnings about similar products over the past decade, the agency continues to find potentially dangerous products available for purchase on the internet, including from online marketplaces like Amazon and eBay, as well as in retail stores. The agency urges consumers to beware of purchasing or taking these products.

“Protecting the health and safety of Americans is the FDA’s highest priority, and we will remain vigilant and communicate about products and companies that place U.S. consumers at risk,” said Donald D. Ashley, J.D., director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “While the FDA has engaged in discussions with online marketplaces like Amazon and eBay regarding these issues in the past, we believe they can do more to...

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Wednesday, December 16, 2020

 

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Friday, December 11, 2020

 

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Former Sales Representative Admits Role in Compounded Prescription Drug Scheme

 epartment of Justice

U.S. Attorney’s Office
District of New Jersey

FOR IMMEDIATE RELEASE
Wednesday, December 9, 2020

Former Sales Representative Admits Role in Compounded Prescription Drug Scheme

NEWARK, N.J. – A former sales representative today admitted his role in a scheme to defraud a New Jersey state health benefits program, U.S. Attorney Craig Carpenito announced. 

Thomas Bowers, 46, of Little Falls, New Jersey, pleaded guilty by videoconference before U.S. District Judge William J. Martini to an information charging him with conspiracy to commit health care fraud.

According to documents filed in this case and statements made in court:

Compounding is a practice in which a pharmacist or physician combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. The Food and Drug Administration does not approve compounded drugs and thus does not verify the safety, potency, effectiveness, or manufacturing quality of compounded drugs. Generally, a physician may prescribe compounded drugs when an FDA-approved drug does not meet the health needs of a particular patient.

Between December 2014 and March 2016, Bowers worked as a sales representative for a marketing company that marketed and sold compounded drugs to physicians, including pain, scar and wound creams and certain supplements and vitamins. Certain compounding pharmacies paid the marketing company based on a percentage of the reimbursement payments they received from health care benefit programs for each prescription that Bowers referred to the pharmacies. The marketing company, in turn, paid Bowers based on the compounded prescriptions he generated. Bowers recruited patients, including family members, who had prescription drug coverage under the New Jersey School Employee’s Health Benefits Program, to obtain medically unnecessary prescriptions for compounded drugs. Bowers paid patients that he recruited to obtain prescriptions from doctors even though the doctors did not have any interaction with the patients for purposes of determining that a prescription was medically necessary. He obtained medically unnecessary prescriptions from doctors who only conducted a cursory patient examination that was insufficient to legitimately deem that a compounded drug was medically necessary for the patient.

The count of conspiracy to commit health care fraud carries a maximum penalty of 10 years in prison and a $250,000 fine, or twice the gain or loss from the offense, whichever is greater. As part of his plea agreement, Bowers must forfeit $157,747 in criminal proceeds and pay restitution of at least $593,678. Sentencing is scheduled for April 8, 2021.

U.S. Attorney Carpenito credited special agents of the FBI, under the direction of Special Agent in Charge George M. Crouch Jr. in Newark, and Defense Criminal Investigative Service, under the direction of Special Agent in Charge Patrick J. Hegarty, with the investigation leading to today’s plea.

The government is represented by Assistant U.S. Attorney Adam Baker of the United States Attorney’s Office, Opioid Abuse Prevention and Enforcement Unit in Newark.

Topic(s): 
Health Care Fraud
Component(s): 
Press Release Number: 
20-450

Partners Group to acquire leading US animal-health compounding pharmacy Wedgewood

 

Partners Group to acquire leading US animal-health...

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Supreme Court rules that states can regulate pharmacy benefit managers Richard Wolf USA TODAY

https://www.usatoday.com/story/news/politics/2020/12/10/drug-prices-supreme-court-says-states-can-regulate-rx-drug-middlemen/3878386001/