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Latest From Michael McCaughan
The nomination of a former drug industry executive to run HHS is obviously good news for the biopharma sector, but it does not mean that HHS will do nothing about drug prices. On the contrary, it may make some high-profile action against pricing outliers all but inevitable.
The Trump Administration isn’t likely to drop the idea of having user fees pay the full cost of reviews. The pharmaceutical industry can afford higher fees, but industry officials worry about the perception if reviews are fully funded.
In interview with the Pink Sheet, US FDA Commissioner Gottlieb indicates agency won’t be making complete response letters public any time soon. Agency will still strive for greater transparency in its regulatory decisions, however.
Latest headlines about EpiPen cite deaths associated with product 'failures.' The attention is probably unfair, given the source (US FDA adverse event reports) but it is also inevitable given the history – and may be a warning of headlines to come if and when a generic is approved.
A Senate hearing on drug pricing and the supply chain inevitably focused on the role of rebates. Committee Chairman Lamar Alexander offered a simple-sounding solution: get rid of them. That’s easier said than done, of course, but it did trigger some interesting discussion from different trade sectors.
Ophthalmology supervisory medical officer Wiley Chambers played a key role at three different advisory committee meetings in early October. Only one was a review in his division.