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Latest From Michael McCaughan
During the first step of the confirmation process, HHS Secretary nominee Alex Azar did a good job of framing his industry background as useful experience for tackling drug prices. But wouldn’t it be nice if everyone agreed that 10 years as Lilly was something to be proud of?
Former Commissioner Margaret Hamburg made advancing regulatory science a centerpiece of her tenure, but it sounds like the term ‘regulatory science’ has outlived its usefulness.
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.