Category Archives: Legal

UK Drug Pricing: An ICER of Zero?

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 […]
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Obama Administration Halts Attack on Medicare Drug Plans

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 […]
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Obama Budget Takes Slap at Pharma

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.
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New Fees Made FDA Worse for Generic Drug Approvals, Says GPhA Chairman

‘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 […]
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Merck in Gender Bias Wrangle

Four class representatives have been added to a class-action gender-discrimination employment suit originally filed last May against Merck & Co. in New Jersey.
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