WASHINGTON — The Senate on Thursday, without fanfare or controversy, approved legislation that will keep many Food and Drug Administration operations running and deliver a significant win to the pharmaceutical industry.

Lawmakers voted 94-1 to approve the so-called “user fee agreements” that govern how much private drug and device makers pay in fees to support the approval and oversight processes at the FDA. Sen. Bernie Sanders (I-Vt.) was the only no vote.

The measure, which cleared the House of Representatives last month, now heads to President Trump for a signature.


The bipartisan package had long been expected to clear Congress. The FDA casts the agreements as “critical” for its ability to keep the lights on, and existing agreements are set to expire at the end of September.

But the 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.

Some lobbyists and staffers suggested Sanders (I-Vt.) and other Democrats could introduce an amendment that would allow for the importation of drugs from Canada. Sanders opposed a similar Senate bill earlier this year, saying it did not go far enough to address high prescription drug costs.

Sen. Ron Johnson (R-Wis.) had also suggested he would hold up the package if he was not able to offer legislation that aims to help terminally ill patients access experimental therapies. Ultimately, that measure cleared the Senate earlier Thursday, also by a voice vote.

The Trump administration has made no secret of the fact that it would have preferred a different package. It pushed Congress to reopen the negotiations, which were hammered out between industry officials and the Obama administration in previous years. Trump’s 2018 budget proposal called for doubling the roughly $1 billion in fees the industry agreed to pay to support the approval process.

“In its current form, H.R. 2430 would require significant investment of taxpayer resources in FDA’s medical product review programs,” the White House wrote when the bill passed the House. “The Administration urges the Congress to provide for 100 percent user fee funding within the reauthorized programs. In an era of renewed fiscal restraint, industries that benefit directly from FDA’s work should pay for it.”

At the same time, the White House gave no indication that Trump would veto the legislation.


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