Congress has passed a short-term spending package that will fund the government through February 8, 2018, and allow the FDA to resume normal operations.
Congress has voted to end the US government shutdown. The passage of the short-term spending package will fund the government through February 8, 2018.
The short-term funding agreement is welcome among agencies such as the FDA, which placed nearly half of its staff on furlough during the 3-day shutdown, and paused all work outside “activities necessary to address imminent threats to the safety of human life and activities funded by carryover user fees.”
Though the government has attained funding to carry on with its activities through the next few weeks, the potential for a second government shutdown—one that could potentially be longer than the first—remains overhead after February 8.
For the FDA, government shutdowns have widespread ramifications that can threaten the health and safety of millions of Americans. In the 2013 shutdown, nearly all of the agency’s food safety inspections ceased, along with most of its lab research aimed at informing public health decisions, as did agency efforts to keep drug labelling accurate and up to date.
Margaret Hamburg, MD, FDA Commissioner during 2013, told STAT that the drug approval process was also impacted by the shutdown: “As you know, [industry-funded] programs could continue, but there were delays, advisory committee meetings had to be canceled, review teams were juggling many more tasks [and therefore] less focused and responsive.”
Current FDA Commissioner Scott Gottlieb, MD, said that the agency was be better equipped in the most recent halt in operations than it was in previous shutdowns, and tweeted that the agency has access to carryover user fee funds that allow the agency to continue to review and approve some types of medical products applications.
However, during a shutdown, the government is less capable of carrying out research, addressing issues like drug and device shortages, and monitoring and responding to disease outbreaks.
In terms of financial impact, during every previous shutdown, Congress has allocated back pay for all furloughed federal employees. Thus, shutdowns don’t save the federal government any money, in fact, the 2013 shutdown reportedly cost the government $24 billion, according to the ratings agency Standard & Poor’s.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
December 17th 2023On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
Biosimilars Council: PBM Rebate Schemes Cost Americans, Payers $6 Billion
April 10th 2024A report from the Biosimilars Council evaluating IQVIA data found that rebate schemes orchestrated by pharmacy benefit managers (PBMs) are costing US patients and payers billions of dollars by suppressing biosimilar adoption.