Category Archives: Legal

The Sunshine Act: Cloudier Still?

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 [...]

Also posted in Manufacturing, Medical Education, Meetings, Regulatory, compliance | Tagged Payment disclosure, Physician payments, Sunshine Act | 1 Comment

Patients on the Picket Line

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.

Also posted in Biotech, FDA, Market Access, Regulatory, Safety, healthcare | Tagged Abigail Alliance, breakthrough therapies, Breast cancer, Cancer, compassionate use, Expanded Access Programs, FDA, FDA safety and innovation act, HHS, Market Access, patient advocates, PDUFA V, policy | Leave a comment

State Surprises as Obamacare Starts Up

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.

Also posted in Guest Blog, Strategy, healthcare, leadership | Tagged ACA, health exchanges, Health Reform, HHS, Kathleen Sebelius, Medicaid, Medicare, Obamacare, States | Leave a comment

Five Compliance Questions to Ask Yourself, from the DOJ

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 [...]

Also posted in Corporate Responsibility, Regulatory, Safety, Strategy, compliance, leadership | Tagged compliance, DoJ, Maame Ewusi-Mensah Frimpong | Leave a comment

Tom Abrams: Caronia Won't Stop Off-Label Enforcement

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.

Also posted in Advertising, Agency Insight, E-Media, FDA, Marketing, Regulatory, leadership, social media | Tagged CBI, FDA, First Amendment, misbranding, off-label, OPDP, Tom Abrams, US v. Caronia | 1 Comment