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Senate passes FDA funding package

080317 Senate user fees rk-pic
The bill reauthorizes the FDA's program through which it charges fees for new drug or device applications. (iStock photo)

The Senate overwhelmingly passed legislation to reauthorize key funding for the Food and Drug Administration, with the measure including key amendments to tackle high drug prices and access to experimental drugs.

The Thursday vote of 94-1 sends the legislation on the FDA's user fee program to President Trump, who is expected to sign it, according to a White House aide.

Sen. Bernie Sanders, I-Vt., was the lone no vote.

The bill reauthorizes the FDA's program through which it charges fees for new drug or device applications. The FDA in turn uses that money to speed up approval of new drugs and devices.

The program must be reauthorized every five years and traditionally receives bipartisan support.

Included in the package are amendments to boost competition for generic drugs. One amendment lets the FDA speed up approval of a generic drug to compete with a drug that has limited or no competition and its manufacturer has jacked up its price.

Another amendment directs the FDA to look into barriers for access to clinical trials in an effort to expand access to experimental treatments for terminally ill patients.

Trump had previously called for the agency to be completely funded through user fees instead of a mix of fees and federal funding. But lawmakers on both sides of the aisle told the president that the agreement couldn't be renegotiated this late in the game, after the FDA and the drug and device industries negotiated for more than a year.

The bill's passage occurred much later than in prior years. The last reauthorization package in 2012 passed Congress in late June.

The FDA delayed sending notices to workers who would be laid off if the user fee program isn't reauthorized. Normally the notices would have been sent by now, but FDA Commissioner Scott Gottlieb said he expected the user fee program to be reauthorized.

* This article has been updated.