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FDA user fee renewal urgent, but hearing gets diverted to drug prices, NIH cuts


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FDA user fee renewal urgent, but hearing gets diverted to drug prices, NIH cuts

Lawmakers on Capitol Hill are racing to complete a massive bill to renew the FDA's four drug and device user fee programs by Sept. 30 or the agency will lose more than half of its funding, resulting in substantial layoffs of scientists and other staff and slowing down the time it takes for new therapies to enter the market.

But Sen. Lamar Alexander, R-Tenn., chairman of the Senate Health, Education, Labor and Pensions Committee, said he was not going to let that happen and pledged during an April 4 hearing to work across the aisle to get the job done.

Sen. Patty Murray, D-Wash., the panel's ranking member, agreed she would do the same and even warned President Donald Trump not to get in the way by undermining or altering the agreements the FDA has already struck with industry on the user fee amounts manufacturers would pay and the negotiated agency performance goals.

Congress initially set up the user fees program in 1992 to give the FDA authority to collect the funds from brand-name manufacturers to help cover the costs of drug application reviews. Lawmakers later added programs for medical devices, generics and biosimilars.

The user fees have helped the FDA to significantly reduce its medical product application review times, industry representatives confirmed during the hearing.

Sen. Richard Burr, R-N.C., however, suggested for the second time in the past month that the FDA be required to pay back funds to industry and the government if the agency failed to meet its agreed-on performance goals, although at the April 4 hearing he called for taxpayer appropriated money to be "clawed back," versus the user fees he insisted on during a March 21 hearing.

Industry representatives, however, said the FDA had been on top of things.

Drug prices urgent issue, too

The user fee programs must be renewed every five years, and Alexander emphasized Congress was under the gun to meet the upcoming reauthorization deadline and could not get distracted by other issues.

But as with other recent healthcare hearings on Capitol Hill, the high costs of prescription drugs got worked into the conversation — led by Murray, who acknowledged that while the user fee renewal was a high priority for Congress, so too was the "related, larger issue" of affordability of medicines.

She insisted Congress must tackle the "astronomical cost of prescription drugs" during the current congressional session, although she stopped short of saying she would hold up the user fee bill to get her way and emphasized that pursuit should be done "outside the FDA context and outside this committee's jurisdiction."

That did not stop Murray, though, from pressing industry representatives at the hearing about the cost issue, demanding to know why drugmakers do not provide more transparency on how they set prices.

"I don't exactly know how to answer that question, obviously," Kay Holcombe, senior vice president for science policy at the Biotechnology Innovation Organization, responded, adding that the issue was "complicated."

"I think it's important to realize that the price that a patient is paying at the pharmacy counter, for example, is not the price that is set by a drug company, but it is the price that the insurance plan this individual has is allowing to happen," Holcombe said.

Getting drugs from the lab to the patient "is a system in which there are many players" — biopharmaceutical companies, insurers, pharmacy benefit managers and others, Holcombe said.

"We have to figure out together how to make that system work better for American families," she said.

Sen. Margaret Wood Hassan, D-N.H., noted one of her constituents was paying $34,000 out-of-pocket for his cancer medicine "and it's just something he cannot afford."

"The average cost doesn't matter when you're not part of the average," the senator said.

The drug industry needs to disclose its costs for research and development, manufacturing and marketing "so that we can have a common understanding of what really is driving the costs of pharmaceuticals and address it," Hassan said.

"This is freaking people out; it really is," added Sen. Al Franken, D-Minn., who called on Alexander to convene a hearing devoted to biopharmaceutical costs.

NIH budget cuts

Murray, Hassan, Franken and others also used the user fee hearing to criticize Trump's March 16 proposal to cut the National Institutes of Health's fiscal-year 2018 spending by $6 billion.

But Alexander dismissed Trump's proposal, noting the House and Senate appropriation committees had already agreed to boost the agency's budget.

"Congress has a pretty firm attitude on the National Institutes of Health's funding. It's a top priority for us," he said.

Other Republicans recently expressed similar opinions, including Reps. Kevin Yoder of Kansas and Fred Upton of Michigan.