FDA and FTC Warn CBD Marketers
April 8, 2019 | Marc S. Ullman | Cannabis | FDA | Legislation and Public Policy | Pharmaceuticals

On March 28, the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) sent joint Warning Letters to three marketers of products represented as cannabidiol (popularly known as CBD) dietary supplements. According to the letters, the products are being marketed with questionable claims indicating that they can be used to treat a variety

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Medtronic Warns of Defibrillator Hacking Vulnerability
March 27, 2019 | Eric D. Fader | Cybersecurity | Electronic Health Records | FDA | Legislation and Public Policy | Medical Devices and Wearables | Telehealth

Medtronic PLC self-disclosed last week to the U.S. Food and Drug Administration (FDA) that an unspecified problem in the wireless technology of 19 models of the company’s defibrillators makes them vulnerable to being hacked. The company said it is not aware of any cyberattacks, privacy breaches, or patient harm related to the 750,000 vulnerable devices.

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FDA Issues Warning Letter on Unapproved Breast Implant Device
February 19, 2019 | Steven Shapiro | FDA | Litigation | Medical Devices and Wearables

Last week, the U.S. Food and Drug Administration (FDA) announced that it issued a warning letter to Mark Berman, M.D., a Beverly Hills, Calif., cosmetic surgeon, for illegally marketing an unapproved implantable device. Dr. Berman claims that the “Pocket Protector” can prevent and treat capsular contracture (tightening of scar tissue), a complication of breast implants.

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FTC to Focus on Unsubstantiated Health Claims
January 30, 2019 | Steven Shapiro | FDA | Fraud and Abuse | Litigation | Pharmaceuticals

On January 28, the Federal Trade Commission (FTC) published on its Business Blog a post titled “Hey Nineteen: Nine FTC developments that could impact your business in 2019.” Of most importance to the healthcare industry is the FTC’s promise to focus on unsubstantiated health claims in advertising. The relevant paragraph of the post reads as

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Diabetes Pill Marketers Settle FTC Complaint
December 14, 2018 | Steven Shapiro | FDA | Fraud and Abuse | Litigation | Pharmaceuticals

On December 4, the Federal Trade Commission (FTC) announced the settlement of a complaint against Nobetes Corporation, which marketed and sold a pill that supposedly treats diabetes. The FTC complaint had alleged that the company made false or unsubstantiated health claims, engaged in illegal billing practices, and used deceptive endorsements in the marketing and sale

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DOJ Files Amicus Brief Declaring Intention to Dismiss FCA Case
December 12, 2018 | Geoffrey R. Kaiser | FDA | False Claims Act | Fraud and Abuse | Legislation and Public Policy | Litigation | Pharmaceuticals

On November 30, the U.S. Department of Justice (DOJ) filed an amicus curiae brief urging the U.S. Supreme Court to deny a petition for a writ of certiorari filed by Gilead Sciences, Inc. from a Ninth Circuit Court of Appeals decision which had revived a declined False Claims Act (FCA) lawsuit brought by two former

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FDA Reviews Clinical Research Approval Process
November 28, 2018 | FDA | Legislation and Public Policy | Pharmaceuticals

The U.S. Food & Drug Administration (FDA) has contracted with Eastern Research Group, Inc. (ERG) to review the FDA’s investigational new drug (IND) approval process. The IND phase of drug development is when human trials of new drugs are conducted. The FDA receives 4,000 IND requests a year.

In order for a new drug to

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