Also, what the heck happened to Section 209 of the HELP bill? 

 
When the HELP Committee unveiled its package of health care reforms last month, it included one provision insulin makers have been seeking for years — a policy change that would make sure the FDA can’t hold up an application for a biosimilar insulin between now and 2020, when regulations on the issue are set to take effect. But alas, without explanation, that provision is gone from the revised package voted out of the HELP committee last week. Instead, it has been replaced with language requiring the FDA to return any fees it collected for applications that were denied due to the transition ... which, frankly, is a pretty meager consolation prize. 
 
Staff for the committee did not respond to my questions as to why the provision had been stripped out. If you have the inside scoop, I’m at nicholas.florko@statnews.com. 
 
For more on why this is such a big issue for insulin makers, and why it’s likely keeping cheaper insulin off the market, check out my deep dive here.