Last Stop: President Obama – 21st Century Cures Bill Passes Through the Senate and Heads to Obama for Signature
December 9, 2016
After passing through the House of Representatives with an extraordinary amount of support last week, the 21st Century Cures Act headed to the Senate on Monday, December 5th. On Wednesday, December 7th, the Senate passed the legislation with an overwhelming 94-5 vote.
According to a recent article from the Wall Street Journal, “the bill’s mechanisms allow the FDA to use shorter and simpler studies more widely.” As such, WSJ also explains that the passage of this new legislation could lead to shorter trials for certain new antibiotics. Furthermore, the article states that “a fairly wide range of drugs could get additional approvals for new uses based on relatively low amounts of evidence, such as data summaries and data from company registries.”
The act, which is intended to speed up drug and device approvals at the FDA, now has one final stop to make: President Obama’s desk. After the Senate’s vote, President Obama commented that he intends to sign the bill immediately upon receiving it, which leads us to believe that this will be complete in the very near future.
It will be very interesting to watch as the fate of the 21st Century Cures Act unfolds in the next few days and weeks, as well as how it evolves and potentially changes as a new president moves into the White House.
FDA Makes Changes to Regulations Concerning Humanitarian Use Devices
On Wednesday, June 7th, the FDA amended its final rule concerning humanitarian use devices (HUDs). The amendments to the regulations are being made in response to changes recently enacted into law by...