Tag Archives: HHS

The First Day of Obamacare: Is US Pharma Ready?

by Tom Norton For more than three years, the US pharmaceutical industry has known that today would arrive. So this is it. The first day that eligible U.S. citizens can sign up for Obamacare — and enjoy the prospect of prescription drug insurance, effective January 1st, 2014. I have spent the last week surveying many […]
Posted in Guest Blog, healthcare, Legal, Market Access, pricing, R&D, Regulatory, Sales, Strategy | Also tagged , , , , , , , | 1 Comment

Co-Pay Offset Programs and Health Insurance Marketplaces: Causes for Concern

Co-Pay Offset Programs and Health Insurance Marketplaces As the health insurance marketplaces begin enrollment next week and go-live on January 1, 2014, several issues continue to be a source of significant confusion to manufacturers, payers and millions of consumers who will be purchasing health insurance for the first time through an exchange.  Many of these […]
Posted in Guest Blog, healthcare, Op-Ed | Also tagged , , , , , , , | Leave a comment

FDA, CDER Weigh Organizational Changes

FDA commissioner Margaret Hamburg has formed a top-level working group to propose strategies for enhancing agency functions and processes, starting with the relationship between FDA Centers and its field force. The Program Alignment Group (PAG), announced Sept. 6, 2013, will seek to clarify the roles and responsibilities of product centers and the Office of Regulatory […]
Posted in FDA, Legal, Manufacturing, People, Regulatory, Strategy | Also tagged , , , , , | Leave a comment

Rx Brand Managers: Will Your Products Be Covered Under Obamacare?

by Tom Norton We are now less than three weeks away from the initial sign up period for Obamacare. After October 1st, the reality of the program and all that it portends for the future of the US pharmaceutical industry will begin to make itself apparent. One area that is of extreme concern to Rx […]
Posted in Guest Blog, healthcare, Legal, Market Access, Regulatory, Strategy | Also tagged , , , , , , , | Leave a comment

CMS taps IT firm CGI for Sunshine Act Data Dump

Speaking at CBI’s Sunshine & Aggregate Spend Conference in Washington DC on Tuesday, Shantanu Agrawal, director, data sharing and partnership group, center for program integrity, CMS, said the agency hired IT company CGI to build the software platform to be used for publishing pharma payments to physicians under the Sunshine Act provisions, now re-branded “open […]
Posted in Agency Insight, Deals, E-Media, FDA, healthcare, People, Technology | Also tagged , , , , , , , , , , , , , , | Leave a comment
  • Categories

  • Meta