Category Archives: Legal
By Guest Blogger | Published: March 19, 2014
by Leela Barham The incremental cost effectiveness ratio (ICER) – or the threshold for determining whether the costs of a new medicine are worth it – has been controversial since it’s inception. There are those who deny that anyone can put a price-tag on life; those that accept the concept but are happy to let […]
By Jill Wechsler | Published: March 10, 2014
In an abrupt about-face, the Obama administration halted its ill-timed effort to launch an overhaul of the Medicare Part D program and announced it would not pursue changes in some key rules as proposed earlier this year. CMS had issued a proposed rule January 10 to drop “protected” class status for antidepressants and immunosuppressants in […]
By Jill Wechsler | Published: March 7, 2014
Despite a slight boost in funding for the Food and Drug Administration and stronger tax incentives for investment in R&D, significant changes in Medicare drug reimbursement and coverage policies have biopharmaceutical companies up in arms.
By Ben Comer | Published: February 26, 2014
‘Actions’ don’t speak louder than words in dealing with FDA’s backlog of generic drug applications, says newly-elected GPhA Board Chairman Craig Wheeler. When the Generic Drug User Fee Act (GDUFA) was signed into law on July 7, 2012, its primary intent was to provide FDA with the additional resources necessary to expedite the review process […]
By Pharm Exec | Published: February 20, 2014
Four class representatives have been added to a class-action gender-discrimination employment suit originally filed last May against Merck & Co. in New Jersey.