Senate Renews FDA’s User Fees Authorization, Passes ‘Right-To-Try’ Bill
The fees account for about $1.4 billion of the FDA’s approximately $5 billion annual budget, and helps pay for agency reviews that get the products to the marketplace. Meanwhile, critics of the "right-to-try" bill call it "inherently dishonest" and unnecessary.
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 Washington Post:
Senate Passes ‘Right To Try’ Bill To Help Terminally Ill Patients Get Experimental Drugs
The “right-to-try” legislation has been championed by the libertarian Goldwater Institute, which has worked to pass similar legislation in 37 states. The federal version, now headed to the House, would bar the government from blocking patients from getting access to medications that have undergone only preliminary testing in humans. Patients first would have to try all other available treatments and be ineligible for clinical trials. The bill would provide drug companies some legal protection if a treatment results in harm. (McGinley, 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)
Politico:
Libertarians Score Big Victory In 'Right-To-Try' Drug Bill
The bill, S. 204 (115), passed swiftly and easily in a Senate bitterly divided over health care. The powerful pharmaceutical lobby, which had quietly opposed an earlier version, kept an unusually low profile. The industry has been focused on fighting off any efforts to go after drug pricing, which President Donald Trump has said he would tackle. (Karlin-Smith, 8/3)
The Associated Press:
FDA OKs New Drug To Treat All Forms Of Hepatitis C
U.S. regulators have approved the first drug to treat all forms of hepatitis C in as little as eight weeks. The pill combination from AbbVie Inc. was approved Thursday by the Food and Drug Administration for adults without significant cirrhosis, a type of liver disease, and many patients who were not cured by prior treatment. (8/3)