Medical Legal False Claims Act: Device Maker Settles For $8 Million For Allegedly Selling… Thomas Sullivan Sep 24, 2014 0 An interesting False Claims Act issue cropped up in a recent $8 million settlement involving U.K.-based medical device…
FDA FDA Releases Guidance Describing the Agency’s 510(k) Review Process Thomas Sullivan Sep 24, 2014 0 The Food and Drug Administration has released a guidance document that offers insight into their decision-making when reviewing…
HHS-OIG Anti-Kickback Alert: Pharmaceutical Manufacturer Copayment Coupons and… Thomas Sullivan Sep 23, 2014 0 Pharmaceutical manufacturers routinely offer copayment coupons to reduce or eliminate the cost of patients'…
Open Payments Physician Payments Sunshine Act: PhRMA, AdvaMed, and BIO Ask CMS to Engage… Thomas Sullivan Sep 22, 2014 0 Life science trade associations PhRMA, Advamed, and BIO have sent a letter to the Centers for Medicare and Medicaid Services (CMS)…
Open Payments Physician Payments Sunshine Act: Bipartisan Members of Congress Introduce… Thomas Sullivan Sep 22, 2014 0 Two bipartisan efforts in Congress underscore the importance of up-to-date medical education. On Thursday, Reps. Michael Burgess…
Open Payments Physician Payments Sunshine Act: Bipartisan Congressional Leaders Urge CMS… Thomas Sullivan Sep 22, 2014 0 In a notable demonstration of bipartisanship, Representatives Michael Burgess (R-TX), Vice Chairman and Frank Pallone (D-NJ),…
FCPA GSK Chinese Bribery Scandal Ends in $489 Million Fine, Executive Sentenced Thomas Sullivan Sep 19, 2014 0 In July of last year, Chinese authorities accused GlaxoSmithKline (GSK) of using a network of travel agencies to channel around…
Collaborations “Accelerating Medicines Partnership” and other Collaborations… Thomas Sullivan Sep 19, 2014 0 AMP - Accelerating Medicines Partnership In February, we wrote about the National Institutes of Health (NIH) announcement of a…
Medical Legal FCA Allegations Dismissed Against Pharmacies For Allegedly Overbilling… Thomas Sullivan Sep 18, 2014 0 A New York federal judge recently dismissed two separate cases brought by Fox Rx Inc.--one against Omnicare, the other…
DOJ PhRMA and DOJ Go Back and Forth Over Off-Label Speech and the First… Thomas Sullivan Sep 17, 2014 0 A whistleblower’s False Claims Act (FCA) suit in the Eastern District of California has caught the attention of the…