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In Brief: FTC, FDA Enforcement; Insider Trading On NBTY Sale; Comment Period On Label Changes

 
• By Elizabeth Crawford

FTC says Pure Green Coffee perks false claims; NBTY shareholder settles insider trading case; scientific citations trigger warning letter; supplement labels must detail plant source; scientific citations trigger warning; and more news In Brief.

The Federal Trade Commission alleges NBP Advertising Inc.’s Pure Green Coffee business makes false claims about a self-named supplement and creates fake blogs and news sites to promote the weight loss product, according to a May 19 announcement. In addition, NBP misappropriated logos from actual news organizations, including CNN, to confuse consumers about whether they are viewing an advertisement or news piece, according to FTC’s complaint filed in the U.S. District Court for the Middle District of Florida, Tampa Division. The commission also notes the Tampa-based firm failed to disclose it paid endorsers for video testimonials and provided them free product. The allegations recall an enforcement blitz that FTC brought against at least 10 affiliate marketers of acai supplements in 2011 for faking news investigations to advertise their supplements Also see "FTC Continues Acai Crackdown With Blitz Against Affiliate Marketers" - Pink Sheet, 25 April, 2011..

A former [NBTY Inc.] board member and some of his family members agree to pay $500,000 to resolve allegations of...

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Real-Time Release Of CRLs Is US FDA’s Goal, Agency Leaders Affirm

 
• By Michael McCaughan

The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.

No Surprise Here: Foreign Drug Facilities Should Expect Surprise Inspections, US FDA Says

 
• By Sue Sutter

The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.

Base Benefit-Risk Decisions On Data, Not Opinion And Passion, CDER’s Tidmarsh Says

 
• By Sue Sutter

New US FDA drugs center director George Tidmarsh’s data-centric comments at a Reagan-Udall Foundation meeting on unapproved fluoride products could suggest patients’ and caregivers’ experiences will carry less weight in benefit-risk decisions under his leadership.

Pink Sheet Podcast: FDA’s New Top Drug Regulator, Sarepta’s Options After Elevidys Stand-Off

 
• By Derrick Gingery, Sarah Karlin-Smith, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the potential impact George Tidmarsh could have as director of the US FDA Center for Drug Evaluation and Research and the issues threatening the future of Sarepta’s gene therapy Elevidys.

More from North America

EMA Says ‘No’ To Roche/Sarepta’s Elevidys, US FDA Investigates Fourth Death

 
• By Eliza Slawther and Sarah Karlin-Smith

The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.

Merck’s Keytruda Gains Medicare Negotiation Reprieve With Expanded Orphan Exemption

 
• By Cathy Kelly

Bristol Myers Squibb’s Opdivo and Merck's Welireg also could benefit from the delay in Medicare price negotiation process eligibility.

US FDA’s Biologics Center Departures Grew Before More Than 100 RIFs Exited

 
• By Derrick Gingery

The Center for Biologics Evaluation and Research saw departures far outnumber new hires in the second and third quarters of FY 2025, before more than 100 people left July 14 after the reduction-in-force was finalized.