FDA’s Oncology Center of Excellence (OCE) is currently not receiving funding from 21st Century Cures even though both a lawmaker and the agency head said they believed resources provided through the act were intended to go to the center. An FDA spokesperson told Inside Health Policy that FDA “is currently using existing agency funds to support the OCE” and that the National Institutes of Health and FDA are exploring how resources could be transferred through the Economy Act.
During a Thursday (May 25) House Appropriations subcommittee hearing, Rep. Kevin Yoder (R-KS) noted there is money from 21st Century Cures “that we intended to get to the FDA to create this Oncology Center of Excellence.” Yoder asked FDA Commissioner Scott Gottlieb what the committee needs to do to ensure FDA gets the resources it needs for OCE. Gottlieb also said Cures funds were intended for OCE.
“I think the idea of trying to consolidate different domains within a center of excellence in that way makes a lot of sense in certain therapeutic areas, and oncology is probably the one that’s most prominent in that regard. Obviously what we do in that regard also needs to be resourced and there were some resources that I believe were intended to be allocated to the Oncology Center of Excellence that haven’t flowed to the center yet,” Gottlieb said.
An FDA spokesperson told IHP that resources need to be transferred from the NIH innovation fund to FDA but that statutory authority is needed to do so.
“The Cancer Moonshot section of the 21st Century Cures Act did not provide for direct appropriations for the FDA Oncology Center of Excellence (OCE). While funds were authorized to be appropriated to the NIH Innovation Account for the purposes of carrying out activities related to cancer, specific statutory authority is required to transfer resources from one agency to another. The FDA currently is using existing agency funds to support the OCE,” the spokesperson said in a written statement.
Jeff Allen, president and CEO of Friends of Cancer Research, told IHP that there were two innovation funds — one for NIH and one for FDA — but that FDA has had to pull from its initial innovation funds to fulfill a number of other requirements laid out in 21st Century Cures. “It’s difficult for them to even prioritize because of the requirements … some of the funding is not as robust as what was proposed in the [Obama] administration’s budget in sufficient levels to support the implementation of the OCE,” Allen said, adding that the OCE funding was “part of what 21st Century Cures intended to allocate around Moonshot … all of that went to NIH.”
Allen added that it is difficult for NIH to transfer money for OCE to FDA.
“It’s easier for NIH to administer grants for programs … but it’s a different activity or process for them to be able to transfer money over for this specific activity for OCE from NIH to FDA. I don’t know exactly why that was necessarily constructed that way, but given the pace and timing at which the Cancer Moonshot activity funding was able to be linked into the 21st Century Cures initiative as the vehicle — we’re thrilled that happened generally — but in terms of nuanced items, there probably wasn’t time to go through with a fine-tooth comb and say, ‘What is the process with which all these things can be funded?'” Allen said.
There are a couple of options for getting the funds to FDA, Allen said, with the most helpful being that the appropriators clarify that a portion of the funds be directed to FDA.
“They still have oversight of those dollars so they would be able to make sure OCE receives that transfer. That would be clearest for Congress to say, ‘This is what we intended for a portion of that money,'” he said.
However, because NIH and FDA are overseen by different appropriations subcommittees, it would be up to the subcommittee for NIH to approve the transfer. The May 25 meeting was held by the subcommittee that oversees FDA.
“[T]here are different subcommittees for oversight between NIH and FDA and since this is a transfer from NIH, it’s the [Labor, Health and Human Services, Education, and Related Agencies subcommittee] that would have to prioritize and make that happen. I hope there’s a good recognition of the importance [FDA] plays in translating all the discoveries that are at the heart of the funding that they allocate to the NIH … Having FDA and the coordination OCE can provide to oncology is really important to the success of the other funds they provide,” Allen said.
FDA’s spokesperson told IHP the agencies are currently looking at how resources could be transferred from NIH to FDA through the Economy Act, which allows an agency to place an order with another agency for goods or services if “amounts are available,” “the head of the ordering agency or unit decides the order is in the best interest of the United States Government,” “the agency or unit to fill the order is able to provide or get by contract the ordered goods or services” and “the head of the agency decides ordered goods or services cannot be provided by contract as conveniently or cheaply by a commercial enterprise.”
The act also sets out that payment can be made to the agency or unit filling the order in advance, or once goods or services are provided.
“Generally, under the Economy Act, agencies may enter into an interagency agreement, or IAA, which is a written arrangement between federal agencies that specifies the goods or services provided by one agency to support another agency. Those services must be an authorized use of the original appropriation. This means the Economy Act could only be used to provide services to NIH, but could not be used for FDA to carry out their own responsibilities. Beyond the Economy Act, HHS does not currently have authority to transfer resources from NIH to FDA. The 21st Century Cures Act prohibits the transfer of NIH resources outside of NIH. NIH and FDA are currently exploring what assistance FDA may provide NIH through the Economy Act,” the agency spokesperson told IHP.
During the May 25 hearing, Yoder urged the committee to work to resolve the issue. “There were dollars that we intended to get to the FDA to create this Oncology Center of Excellence to get drugs to market to help people who are suffering from cancer and because of, basically, technicalities it’s not happening. So I think this is something we need to follow up on and fix,” he said.
Gottlieb also warned that OCE, if not successful, would halt progress for other therapeutic spaces. “I believe the model that we’ve created with respect to the Oncology Center of Excellence could be a regulatory model going forward for how we think about a broad range of therapeutic areas,” Gottlieb told the subcommittee. “I’d be happy to work with Congress to make sure we can properly resource that. Not just because I think it’s vitally important that we make that center viable but I do believe that there is a more sustainable model for how we can regulate therapeutic spaces more generally. And if we get it wrong in this first instance, then we can’t skate towards that goal,” the FDA chief added.