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US FDA headed for longest shutdown, despite House approval of spending bill


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US FDA headed for longest shutdown, despite House approval of spending bill

The House adopted a spending bill that would fully open the U.S. Food and Drug Administration, but the Republican Senate leader, Mitch McConnell of Kentucky, has no plans to bring the measure up in his chamber, all but assuring the longest shutdown in the agency's history.

A quarter of the U.S. government has been shuttered since Dec. 22, 2018 — now 21 days — caught in the dispute over President Donald Trump's demand for $5.7 billion to fund a border wall between the U.S. and Mexico.

The current closure is now expected to exceed the shutdown that lasted from Dec. 16, 1995, to Jan. 6, 1996 — the longest in U.S. history. It already has surpassed the 2013 government shutdown, when all federal agencies were closed for 16 days.

It is the third time since Trump entered the White House the government has been closed — all three times involving the disagreement over the border wall. It is also the third time FDA Commissioner Scott Gottlieb has led his staff through a shutdown in his short time heading the agency, though he insisted last week he had no plans to exit the job.

Trump is considering declaring a national emergency in an attempt to use funds from other agencies for his wall, possibly even from the supplemental spending package Congress approved last year to respond to the wildfires in California and the hurricanes that struck Puerto Rico, Florida and Texas in 2017.

Shifting resources

Over the past three weeks, the FDA has been operating without more than 7,000 of its employees, or 41% of the agency, causing it to severely restrict its services and work activities.

On Jan. 5, Gottlieb reported his agency had about one-month's worth of user fees left collected from brand-name biopharmaceutical manufacturers to continue regulatory work on new drug applications during the government shutdown.

This week, Gottlieb said the agency would need to take some of those user fees and reallocate them for post-market drug safety surveillance activities.

"We're systematically reviewing our portfolio and making sure that our safety functions remain resourced as best they can, for as long as they can," Gottlieb wrote on Twitter — the platform he has been using to communicate to the public during the shutdown. "Our consumer protection role is our most critical mission."

The functions that can most directly impact consumer safety will continue, "to the best of our abilities, subject to the legal and financial limitations of the current circumstances," he added.

Gottlieb said he would provide more details on the reallocations in the coming days.

Even though the FDA is part of the U.S. Department of Health and Human Services, which was already funded for fiscal 2019, the food and drug agency's allocations are funneled through the U.S. Department of Agriculture, which has not yet been funded.

In a 243-to-183 vote on Jan. 10, the House adopted the Agriculture, Rural Development, FDA and Related Agencies Appropriations Act, or H.R. 265 — one of three spending bills the chamber has approved this week. A fourth appropriations bill to fund the Departments of the Interior and Environment and some other agencies is slated to be voted on by the House on Jan. 11.

The House is also expected to adopt a bill sponsored by Maryland Democratic Sens. Chris Van Hollen and Ben Cardin that would assure back pay for the currently furloughed federal workers — a measure the Senate recycled through in the new Congress on Jan. 10 after initially taking it up on the eve of the shutdown.

Many of the FDA's workers are Van Hollen's and Cardin's constituents.

FDA funding

Rep. Sanford Bishop, D-Ga., chairman of the House Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Subcommittee, noted the bill that would fund the FDA was largely the same measure that was approved in a 92-to-6 vote by the Senate in December 2018 — a spending package the then-Republican controlled House refused to take up.

The Senate could fully restore the FDA and the other shuttered agencies by approving the now House-adopted bills, Bishop noted on the chamber floor on Jan. 10.

The legislation would provide the FDA $2.97 billion in discretionary funding for fiscal 2019, which is $159 million above the fiscal 2018 enacted level — a 6% raise. With user fee revenues, the FDA would be funded at $5.4 billion for fiscal 2019.

Bishop noted the House-approved bill included more funding for the U.S. opioid crisis than the appropriations legislation crafted last year by the chamber — the package it failed to take up in December 2018, triggering the shutdown.

The newly adopted legislation also would provide more funding for food safety than the earlier House bill, he said.

Ignoring earlier House work

But Rep. Steven Palazzo, R-Miss., who objected to the measure, said that adopting the Senate's version of the spending legislation "completely ignores" all of the appropriations work House lawmakers did last year.

The earlier House version would have provided more funding overall for the FDA than the Senate bill, Palazzo said.

That extra money in the original House bill would have provided additional support for a number of medical product initiatives, including ones to promote manufacturing in the U.S., the new domestic drug industry and the new medical data enterprise initiative, he said.

"This is critical to helping industry advance medical products to the marketplace sooner, safer and with greater efficiency," Palazzo said. "The ultimate beneficiary is the American consumer or patient."

"By considering the Senate-passed version of the appropriations bills, we're eliminating House members' involvement in the process," Kay Granger, R-Texas, said on the chamber's floor just before voting against the measure.

The lesser amount "means decreased access to medical products," because there are fewer resources to bring them to market in a safe and efficient manner, Granger said.

The bill also would not re-open the FDA and other agencies because Trump will not sign it, she added.

Congress, however, does not need Trump's signature. The Senate could override a veto with 67 votes, while it would take 290 lawmakers in the House to back such a move.