Life Sciences Law & Industry Report connects the dots among the many disciplines that make up the burgeoning life sciences industry, with biweekly updates on current regulatory, legislative,...
Oct. 3 — The delay in Congress to agree on Zika funding caused the HHS to lose potential contracts to respond to the outbreak, the HHS's medical countermeasures chief said Oct. 3.
“We had manufacturers walk away from negotiations with us because they weren’t sure the money was going to be there,” Nicole Lurie, assistant secretary for preparedness and response in the Department of Health and Human Services, said during a press conference. “We likely missed out on some other promising vaccine candidates.”
Federal health officials outlined how they planned to use the $1.1 billion that the department received to respond to the outbreak of a virus that has been declared a public health emergency and has been reported in more than 70 countries, including 59 locally acquired cases in Florida. But the funding, which comes through the continuing resolution (H.R. 5325) that keeps the government running through early December, arrives more than seven months late and $800 million short of what the Obama administration requested in February for emergency spending. Lurie said she couldn't disclose which companies walked away from negotiations because it was procurement-sensitive information.
HHS Secretary Sylvia Mathews Burwell said the department already has responded aggressively to the outbreak, and that the $1.1 billion will support:
“We did not wait for the legislation because the threat was too great,” Burwell said during the press conference. “We’ve made important progress since we began the fight. And thanks to the $1.1 billion in needed funds that Congress just approved, we can build on this progress and continue our work.”
There are nine vaccine candidates, some of which were developed by NIH scientists and some of which are underway with Biomedical Advanced Research and Development Authority contracts and vaccine companies. But Lurie said the funding delay means “we are behind where we should be on vaccine development and diagnostic test development because manufacturers really couldn’t count on funds being there.”
Burwell said the $800 million gap between what the administration requested and what Congress approved has caused shortfalls. The Food and Drug Administration didn't receive any funding for the dozen emergency use authorizations that agency has approved to screen for the Zika virus. Neither the National Institutes of Health, the Centers for Disease Control and Prevention nor BARDA received its full funding request.
“It is important to reflect that there was a reason we asked for the $1.9 [billion]. And those are important uses of money,” Burwell said, adding that much of the money the department had to borrow to pursue a Zika response won't be paid back through the appropriation. “The damage that occurred because we took those funds will continue.”
The NIH requested $200 million and received $152 million, which is enough to pursue a vaccine candidate but isn't enough to pay back any of the money it borrowed from cancer research and other disease areas (10 LSLR 20, 10/15/16).
CDC Director Tom Frieden said his agency won't be able to replenish funds it took from Ebola virus work to pay for Zika, and he said there is still important work on Ebola that needs to be done. “There’s a cost to protecting Americans from the dollars that were reprogrammed,” he said.
The delay also meant that the HHS had to direct time and energy toward seeking funding “instead of working to use the funding,” Burwell added.
“That money would be out the door,” Burwell said, “if we had received the money at the point at which we asked for it.”
To contact the reporter on this story: Jeannie Baumann in Washington at email@example.com
To contact the editor responsible for this story: Randy Kubetin at firstname.lastname@example.org
The continuing resolution is at https://www.congress.gov/bill/114th-congress/house-bill/5325/text.
Copyright © 2016 The Bureau of National Affairs, Inc. All Rights Reserved.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to email@example.com.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to firstname.lastname@example.org.
Put me on standing order
Notify me when new releases are available (no standing order will be created)