US Senate Passes FDA User Fees, Right to Try and Opioid Legislation

After many months of debate, both chambers of Congress passed the FDA User Fee Package. This comes after the Senate passed its bill (S. 934) which cleared the Senate HELP Committee in May on a bipartisan basis. The House passed its bill on July 13 (H.R. 2430). The FDA Reauthorization Act (FDARA) renews and enhances the FDA drug, medical-device, biosimilar, and generic-drug user-fee provisions. The bill was uniquely tied to “Right to Try” legislation, and the Senate also passed bipartisan legislation on the opioid epidemic. Senate FDARA Bill The politics of the bill were intricately locked in with another member of the Senate’s own legislation. Majority Leader Mitch McConnell (R-KY) committed to taking up an amended version of Sen. Johnson’s right-to-try legislation to the floor in a separate vote, which cleared the way for Senate consideration of the user fee package. FDA Commissioner Scott Gottlieb informed agency employees via email on July 24th that he would not be sending out any layoff notices to user fee-funded staff “unless and until September 30 had passed without reauthorization.” The publicizing of this policy decision by the Commissioner may have been intended to signal to the Senate that the sky is not falling (yet), but that they need to get to work. "This program is critical to speeding up the drug approval process, and that's important for everyone frustrated by the time and cost of bringing life-saving drugs to market," McConnell said in floor ...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs