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Purdue Execs’ Exclusion Stands But Court Tells HHS To Justify 12-Year Term

 
• By Brenda Sandburg

The question now is whether HSS Secretary Sebelius will provide a rationale to continue the 12-year exclusion or reduce the length of the exclusion; appeals court upholds HHS’s authority to exclude three former Purdue Pharma executives from federal health care programs, but notes the length of the sanction departs from similar cases.

Although an appeals court upheld the authority of HHS Secretary Kathleen Sebelius to exclude three former Purdue PharmaLP officers from federal health care programs it gave the executives a shot at getting their 12-year exclusion reduced.

“We hold the statute authorized the Secretary’s exclusion of the three executives but her decision was arbitrary and capricious for...

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• By Derrick Gingery and Sue Sutter

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.

US FDA’s Rising First-Cycle Complete Response Rate Draws Congress’ Attention

 
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ACIP Upheaval Leaves Merck & Co. In A Lurch

 
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More from North America

‘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.

US FDA Chief Counsel Position Awaits HHS General Counsel Confirmation

 
• By Sue Sutter

Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.

‘Brainless’ US MFN Policy Could Drive Pharma Investment To Europe

 
• By Francesca Bruce

European health systems already pay far too much for new medicines and payers will not accept higher prices to compensate for lower US prices, according to Anja Schiel, from NOMA, the Norwegian health technology assessment body.