During his confirmation hearing on Wednesday Scott Gottlieb emphasized that he would start his new job as FDA commissioner by focusing on different parts of the agency that have lagged in accelerating drug reviews. With the president beating the table for a streamlined approval process, you can expect some fresh pressure from the top to speed things up. And now Gottlieb — who was already on record on that score — has some additional data to point to for his efficiency campaign, highlighting where the agency has been effective in speeding approvals and where it might push for faster action.
Writing in the New England Journal of Medicine, researchers compared the approval track record for the FDA against the EMA. And once again, the FDA comes out on top. But this is not a blanket endorsement.
Looking at regulatory actions taken between 2011 and 2015, the researchers — Nicholas S. Downing, from Brigham and Women’s Hospital, Audrey D. Zhang, New York University School of Medicine, and Joseph S. Ross, Yale School of Medicine — found that the FDA had approved 170 therapies, compared to 144 from the EMA.
There were significantly more orphan drug approvals at the FDA than the EMA, 43.5% vs. 25% of the approved agents, which will also attract scrutiny as criticism of the orphan incentive program mounts. Reviews were, on average, significantly shorter at the FDA: 306 days compared to 383 days. And if you just look at the same drugs approved by both agencies, the FDA still wins handily — 303 days to 369 days.
But here’s the interesting part.
Where the FDA excelled in beating the EMA was in cancer and hematological drugs. Drugs designed as orphan therapies were also advantaged. That distinction in oncology highlights the role that Richard Pazdur has played in remaking the way that drugs are reviewed and approved in his wing of the FDA. And he’ll be the example that is held up to other regulators to emulate.
Cancer, though, lends itself to faster reviews, as they’re headed to dying, advanced stage patients initially. The risk/benefit profile is significantly different in, say, heart disease or diabetes.
You can expect to hear plenty more after Gottlieb nails down the job as FDA chief.
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