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Oct 17, 2013

NIH Getting Back to Business as Shutdown Ends

  • The NIH and other government agencies involved in biopharma will start getting back to business as usual today following last night’s Senate and House of Representatives votes ending the 16-day partial shutdown that all but ground regulatory activity to a halt.

    Both chambers of Congress agreed to fund the federal government through January 15—including another round of across-the-board budget cuts, or “sequestration,” like the one that took effect March 1—and raise the nation’s borrowing limit or “debt ceiling” through February 7.

    The extensions are supposed to give lawmakers and President Obama time to craft more permanent spending accords.

    “Congress put country over party,” declared Sen. Mark Kirk (R-IL) in a statement. Kirk was part of a bipartisan group of senators who crafted the spending accord ending the shutdown.

    The shutdown hit the NIH especially hard, with about three-quarters of agency employees ordered to stay home. The agency responded in part by ending admission of new patients into clinical trials—some 200 are admitted in a typical week—while continuing to care for patients selected before the shutdown began on October 1.

    Even though the NIH enjoys support from both major political parties, a House bill introduced by Rep. Jack Kingston (R-GA) to resume NIH funding—the “Researching for Lifesaving Cures Act”—went nowhere after Democrats ruled out support for partial federal funding bills.

    “For me, the shutdown means that Congress is denying me potentially life-saving treatment. I speak for everyone battling cancer when I say we don't have time to wait,” Michelle Langbehn of Auburn, CA, a sarcoma patient awaiting admission to an NIH trial for an experimental compound, said in a petition demanding an end to the shutdown. The petition collected more than 100,000 signatures after being posted on Change.org.

    Days into the shutdown, the NIH resumed reviews of pending patient applications; Langbehn was declared ineligible for the trial “due to specific features of my cancer.” And in about a dozen instances during the shutdown’s first week, according to several news reports, the agency had relaxed its prohibitions, allowing patients with immediately life-threatening illnesses into the studies.

    “The government shutdown is affecting so many of us across the country in a very personal way. For me, it’s affecting my fight for my life. I've had enough and it's time to get NIH—and our country—moving again,” Langbehn added. 



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