Monthly Archives: February 2013

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 [...]

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

Pharma's Shifting Needs for Scientific Talent

By Guest Blogger | Published: February 7, 2013

By Susan Haigney. Developing and maintaining the right labor pool is an ongoing challenge for any industry, and it is one that the pharmaceutical industry also is facing. Recent attention in the pharmaceutical industry has focused on the restructuring that has occurred and that is still occurring among the large pharmaceutical companies. [...]

Posted in Guest Blog | Tagged PwC, R&D, recruitment | Leave a 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.

Posted in Biotech, FDA, Legal, 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

European Commission Investigates J&J, Novartis

By Guest Blogger | Published: February 4, 2013

By Stephanie Sutton. The European Commission claims that Johnson & Johnson and Novartis may have breached European antitrust rules.

Posted in Europe, Global, Guest Blog, Regulatory | Tagged antitrust, European Commission, Johnson & Johnson, Novartis | 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.

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