Category Archives: Legal
By Clark Herman | Published: February 7, 2013
With the recent release of the Patient Protection Sunshine Act (PPSA), the Center for Medicare and Medicaid Services (CMS) has established reporting requirements to ensure that drug manufacturers properly disclose payments to physicians in areas of research, continuing medical education, etc. However a key uncertainty is the issue of state pre-emption. While state and local [...]
By Ben Comer | Published: February 5, 2013
Good science can’t be rushed, even when the lives of patients hang in the balance. But regulatory science, and its relationship to a drug’s commercial success or failure, can inadvertently block access to individual patients in their hour of need.
By Guest Blogger | Published: February 1, 2013
by Tom Norton This past week or so, with Obamacare’s start up less than a year away, we have been treated to several entertaining vignettes as the nation’s governors begin to wrestle with the realities of the new healthcare law.
By Ben Comer | Published: January 31, 2013
At CBI’s 10th Annual Pharmaceutical Compliance Congress, Maame Ewusi-Mensah Frimpong, deputy assistant attorney general, consumer protection branch, civil division, at the US Department of Justice, said being compliant means understanding people, and their motivations. Frimpong said non-compliance boils down to a failure of individuals, and offered five questions for chief compliance officers to ask themselves [...]
By Jill Wechsler | Published: January 30, 2013
The much-discussed US v. Caronia case, which has raised questions about the Food and Drug Administration prosecution of pharma companies for making off-label product claims, doesn’t change very much, according to FDA’s top drug marketing enforcer.