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DOJ Casting Wider Net In Pharma Kickback Probes

 
• By Brenda Sandburg

Government is pursuing behavior it once would have taken a pass on, former DOJ attorney notes; pharma companies have inked 16 settlements in past year.  

WASHINGTON, DC - MARCH 2018: Headquarters of the U.S. Justice Department. Art Deco aluminum torcheres at doorway. Renamed the Robert F. Kennedy Department of Justice Building in 2001.
Department of Justice has expanded scope of pharma activity that may violate anti-kickback statute

The US government's investigation of pharma companies for health care fraud violations has evolved in recent years, shifting from off-label promotion to anti-kickback allegations. And that has led the Department of Justice to pursue new areas of enforcement action.

"As companies become more compliant and the rules become stricter within industry, that doesn't mean the government has gone away,"...

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‘Sex Pill For Women’: Sprout CEO’s Addyi Instagram Post Draws US FDA Warning Letter

 
• By Sue Sutter

Cindy Eckert’s social media post with a People.com story failed to include any risk information, made misleading representations about benefits and omitted material information about the indication, said the agency, which flagged similar concerns about an Addyi radio ad five years ago.

Novo, Lilly Ad Challenges Cause Discontinued Claims For Compounded GLP-1s

 
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Sarfez Pharma’s Promotional Claims For Diuretic Soaanz Draw US FDA Warning Letter

 
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‘Sex Pill For Women’: Sprout CEO’s Addyi Instagram Post Draws US FDA Warning Letter

 
• By Sue Sutter

Cindy Eckert’s social media post with a People.com story failed to include any risk information, made misleading representations about benefits and omitted material information about the indication, said the agency, which flagged similar concerns about an Addyi radio ad five years ago.

UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
• By Eliza Slawther

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Novo, Lilly Ad Challenges Cause Discontinued Claims For Compounded GLP-1s

 
• By Sue Sutter

Two pharmacies, a medical spa and a telehealth company voluntarily removed efficacy, safety and quality claims for compounded GLP-1 products after innovator companies filed challenges with the National Advertising Division.