Two new developments in First Amendment challenges to off-label promotion: what's next? *

USA - March 13 2013
Following the Second Circuit's marquee First Amendment ruling in the Caronia case, two recent developments demonstrate a shift in the battleground…

Co-authors: Mark A Jensen , Jeffrey S Bucholtz, Brandt Leibe , Wick Sollers , Christopher A Wray (Chris).

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2012 year in review: FDA OPDP Warning Letters and Untitled Letters *

USA - February 5 2013
In 2012, the Center for Drug Evaluation and Research's (CDER) Office of Prescription Drug Promotion (OPDP) issued a total of 28 enforcement letters…

Co-authors: Elaine Tseng, Christina M. Markus, Joanne Chan, Marian Lee .

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CMS issues final rule to implement Physician Payments Sunshine Act *

USA - February 4 2013
On Friday, February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) released the highly anticipated final rule to implement the federal…

Co-authors: Brian Bohnenkamp, Seth H. Lundy, Gina Cavalier , Beverly H. Lorell, MD, Ami Patel .

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Grassroots lobbying laws - a growing trend *

USA - January 25 2013
People do not often associate the terms "lobbying" and "lobbyist" with actions such as posting a flyer, circulating a petition, or taking out a…

Co-authors: Terrence B Burek .

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Massachusetts authorizes pharmaceutical companies to offer drug coupons to Massachusetts residents *

USA - July 10 2012
On July 8, 2012, Massachusetts Governor Deval Patrick signed into law H.4200, which makes appropriations for the state’s fiscal year 2013 budget, and which revises the state’s Health Care False Claims Act (M.G.L. c. 175H, s. 3) to now permit pharmaceutical manufacturers to offer drug coupons to Massachusetts residents.

Co-authors: Brian Bohnenkamp, Seth H. Lundy.

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