Budget

House appropriators noted that only 38,370 prescribers of extended-release and long-acting opioids have been trained through FDA's risk evaluation and mitigation strategy since 2012, which is less than half of FDA's prescriber training goal for 2015 and less than 25 percent of the goal for 2016, coming while FDA contemplates extending the REMS program to immediate-release opioids.

The House Appropriations Committee passed an FDA funding bill that includes report language directing the agency to cease work on its controversial laboratory developed test guidance and to work with Congress on a legislative solution.

House appropriators say in nonbinding report language that FDA should base any guidance to manufacturers on sodium levels in food on an upcoming revision to Dietary Reference Intake (DRI) values being worked on by the Centers for Disease Control and Prevention and the Institute of Medicine (IOM).

Three provisions of the House-passed 21st Century Cures Act -- Patient-Focused Drug Development, Priority Review for Breakthrough Devices, and Modern Trial Design and Evidence Development -- have made their way into appropriations report language cleared by the House agriculture appropriations subcommittee Wednesday (April 13), a House Energy and Commerce Committee staffer confirmed for Inside Health Policy.

The House agriculture appropriations subcommittee cleared a funding bill Wednesday (April 13) with report language that would delay FDA’s controversial guidance bringing laboratory developed tests under the agency’s medical device paradigm, according to Rep. Rosa DeLauro (D-CT), who said she was upset to see such language in the bill.

A bill to cap non-economic damages in medical malpractice suits met the same opposition from states'-rights conservatives at a House Judiciary Committee markup on Tuesday (March 22) as it did in 2011 when the GOP tried to pass the bill.

Every Democrat on the Senate health committee has signed on to legislation that would provide an additional $5 billion annually for a handful of programs at FDA and the National Institutes of Health for the next 10 years.

Rep. Rosa DeLauro (D-CT) raised concerns Thursday that FDA doesn't have enough money to implement the food safety law, noting at an appropriations hearing that the agency has received less than half of what the Congressional Budget Office said would be needed to implement the Food Safety and Modernization Act (FSMA).

The White House laid out as part of its 2017 budget request ways to lower prescription drug costs for state Medicaid programs, coming as the program plays into election-year politics and becomes embroiled in the drug pricing debate.