Bill Renewing FDA’s Authorization To Charge Drug And Device Makers User Fees Passes Senate
The fees account for about $1.4 billion of the FDA’s approximately $5 billion annual budget and help pay for agency reviews that get the products to the marketplace.
The New York Times:
Senate Passes F.D.A. Funding And ‘Right To Try’ Drug Bills
The Senate on Thursday gave final approval to legislation to finance the Food and Drug Administration, clearing the measure for President Trump and tapping drug manufacturers once again to help pay for the federal review of prescription drugs and medical devices. The 94-to-1 vote came just hours after the Senate passed a separate bill expanding access to experimental treatments for people with terminal illnesses. This bill, the Right to Try Act, will now go to the House, where more than three dozen lawmakers have endorsed similar legislation. (Pear and Kaplan, 8/3)
The Associated Press:
Senate Passes Legislation To Ensure No Halt In FDA Reviews
Drug and medical device makers would pay higher user fees under legislation the Senate approved and sent to the president on Thursday. ... The legislation rejects the Trump administration's recommendation to fund FDA reviews entirely through user fees. Doing so would have upended several months' worth of negotiations over the fees, which will generate between $8 billion and $9 billion over five years. The administration had argued that "in an era of renewed fiscal restraint, industries that benefit directly from FDA's work should pay for it." (Freking, 8/3)
Modern Healthcare:
Senate Passes FDA User Fee Reauthorization
The FDA user-fee agreements, which are renegotiated every five years with the makers of prescription brand drugs, medical devices, generic drugs and biosimilars, fund more than half of the FDA's operations. The agency would have to layoff more than 5,000 employees if the agreements are not reauthorized before the end of September. A reauthorization delay would also postpone the review of many drugs and devices. The bill passed 94-1, with Sen. Bernie Sanders (I-Vt.) as the lone holdout. (Kacik, 8/3)
Stat:
Senate Approves Key FDA Legislation, Sending Bill To Trump's Desk
[T]he easy passage on Thursday belies tougher behind-the-scenes negotiations. Senate leaders, along with Sens. Lamar Alexander (R-Tenn.) and Patty Murray (D-Wash.), who together lead the Senate health committee, spent this week fending off controversial amendments that could otherwise have slowed the package’s path to the president’s desk, staff and health industry lobbyists said. (Mershon, 8/3)
CQ Roll Call:
Senate Clears FDA User Fee Renewal Bill
“This is a bill that’s been done the right way,” said Sen. Lamar Alexander, R-Tenn., who oversees the Health, Education, Labor and Pensions Committee. “It’s an example of the way the Senate is supposed to work." (Siddons, 8/3)
The Hill:
Senate Passes Key FDA Funding Bill
The White House hasn’t said if it will sign the user fee bill. In a statement of administrative policy issued in July after the bill passed the House, the White House expressed concern with some minor provisions, though it did not threaten a veto. (Weixel, 8/3)
CQ Roll Call:
Senate Confirms Former Indiana Health Leader As Surgeon General
As surgeon general, Jerome Adams is expected to serve as a spokesman for President Donald Trump's health agenda. Adams, a practicing anesthesiologist, was appointed in 2014 by former Indiana governor and current Vice President Mike Pence to run that state’s department of health. Adams oversaw the state’s response when about 180 residents contracted HIV and hepatitis C as a result of injecting heroin and prescription opioid painkillers. Adams worked to convince Pence to allow an emergency needle exchange program to help stop the outbreak. (Siddons, 8/3)
