Congress Passes Bill to Fund FDA Drug, Medical Device Reviews

(Bloomberg) -- The U.S. Senate cleared a bill to fund U.S. drug and medical reviews by the Food and Drug Administration, sending the measure to President Donald Trump.

The legislation will raise about $9 billion in fees from drug and medical device companies over the next five years, funding FDA reviews of new medical products. The bill cleared the Senate by a vote of 94-1 on Thursday.

New prescription drug applications will generate by far the most revenue, at about $1 billion a year under the measure. Trump had called for even higher fees on the companies, though he's expected to sign the legislation.

The bill was passed by the House of Representatives last month. After House passage, the White House put out a statement that said industry should be funding 100 percent of the FDA's application reviews, which would almost double the fees. Lawmakers said it was too late in the process to renegotiate the bill.

The FDA legislation had been delayed while Republicans dealt with their now-failed effort to repeal and replace Obamacare. Before passing the FDA measure, the Senate passed a bill from Senator Ron Johnson, a Republican from Wisconsin, to expand dying patients' access to experimental drugs. The vote was part of a deal to get Johnson's vote for the FDA legislation.

Experimental access, often referred to as “right to try,” is backed by Vice President Mike Pence.

The FDA and drug and device companies hash out an agreement every five years on the fee amounts and the review timelines the agency will meet, which must be approved by Congress. Lawmakers approved the last deal in 2012 and it will expire at the end of September.

--With assistance from James Rowley

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net.

To contact the editors responsible for this story: Drew Armstrong at darmstrong17@bloomberg.net, Cynthia Koons