Incubate in BioSpace on the FDA and the Federal Government Shutdown

Incubate executive director John Stanford was featured in a BioSpace article by news editor Dan Samorodnitsky on how the ongoing federal government shutdown is affecting the Food and Drug Administration and the broader biopharmaceutical ecosystem.

As the shutdown stretches on, Stanford warned that uncertainty and funding lapses are beginning to slow biotech activity and signal risk to the United States' standing as the global center for innovation. He noted that the prolonged impasse is already delaying key programs like the Small Business Innovation Research (SBIR) initiative, which provides billions in R&D funding for startups across the life sciences sector:

"This is slowing down the ability of biotechs to get answers from the government," John Stanford, executive director of Incubate, a coalition of life sciences investors, told BioSpace, speaking from his car on the way to Capitol Hill to talk with lawmakers.

"This is a different kind of shutdown" in comparison to previous impasses, Stanford said. "The administration is keeping the lights on where it's politically expedient." Other experts who spoke with BioSpace noted that the Trump administration has continuously found sources of funding to keep programs it prioritizes afloat, regardless of the potential legality of spending money that Congress has not specifically appropriated.

While the shutdown's length -- four weeks and counting -- does not broadly affect the bottom line of companies whose timelines are measured in years or decades, there have already been impacts for biopharma, Stanford said.

Top of mind for him is the Small Business Innovation Research (SBIR) program, a U.S. government initiative to fund research and development-oriented start-ups, which lapsed on Oct. 1. SBIR disburses upwards of $4 billion in grants and awards each year, Stanford said, often calling for applications in specific therapeutic areas. Past notable recipients have been companies like Takeda and Alkermes...

...The shutdown is also having a broader effect on the perception of the U.S. and its health industry more generally, Stanford added.