Senate Committee Closes Books On 2016 Pricing Investigation; PBMs In Hot Seat Next?
US Senate Aging Committee wrapped up its investigation into price spikes for off-patent drugs with some relatively unsurprising (and – for most innovator companies – unthreatening) policy recommendations; a brief coda to the report offers two possible directions for future investigations: abuse of the patent system – or the impact of PBM practices.
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Drug Pricing ‘Biggest Offenders’ Are Annual Increases On Widely Used Brands
Express Scripts Chief Medical Officer Steve Miller suggests that caps on annual price increases could significantly ease payer concerns over drug pricing.
Drug Affordability Review By National Academies Kicks Off With Lower Profile Than Expected
A National Academies of Sciences, Engineering and Medicine project on drug access and affordability is kicking off with a very different political backdrop for its deliberations than the one that seemed likely when the working group was selected in late October; its work may still end up mattering a great deal, if and when innovator pricing is back on the table for serious policy review.
ANDAs Can Get Priority, Eight-Month Reviews Under User Fee Deal
GDUFA II gives certain generics the possibility of an even faster review clock, which burnishes FDA's credentials in the drug pricing debate, but in order to take advantage, applications will need to be of high quality in addition to addressing a public health priority.