domingo, 7 de abril de 2019

SCOOPLET: The two Republicans keeping Gottlieb from his white whale

D.C. Diagnosis
Nicholas Florko

SCOOPLET: The two Republicans keeping Gottlieb from his white whale

I couldn’t help but scratch my head when FDA Commissioner Scott Gottlieb included reforms to the over-the-counter drug system among his long list of accomplishments in his weekly Sunday tweetstorm … because, well, that piece of legislation never got across the finish line in the Senate. Nevertheless, the commissioner’s tweet prompted STAT to dig up the latest gossip on what’s going on with that bill. Here’s what we learned:
It’s long been the scuttlebutt in Washington that Sen. Richard Burr (R-N.C.) is blocking the bill because of his anger over how FDA has tried to regulate menthol cigarettes. (Senate rules allow a single senator to block legislation from an otherwise speedy voting process, but those blocks aren’t made public. Burr did not respond to a request for comment.)
But it turns out Burr isn’t the only one standing in the way. Sen. Mike Braun, the newly elected Republican from Indiana, has also blocked the bill from coming to a vote, STAT has learned. In a letter to Senate Majority Leader Mitch McConnell (R-Ky.), obtained by STAT, Braun complains that the bill does not do enough to prevent gaming of the bills’ exclusivity provisions.
“H.R. 269 does not contain adequate oversight mechanisms to ensure that this exclusivity provision is not abused by some OTC drug manufacturers after the reforms of H.R. 269 are implemented by the FDA,” Braun wrote.
Barring some miracle, it looks like Gottlieb won’t get to see this achievement be signed into law before he turns in his keys at the end of the week, despite his best efforts. In conversations with STAT, multiple OTC watchers showered praise on Gottlieb for his willingness to personally support reforms to the OTC system.

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