Swalwell Leads Call for FDA to Help Life-Science Start-Ups Navigate Regulatory Process
WASHINGTON, DC – Rep. Eric Swalwell (CA-15) this week led 12 other House Members in urging that the upcoming budget encourage the Food and Drug Administration (FDA) to increase its educational outreach efforts for life-sciences companies.
Emerging life-sciences companies – often clustered in innovation hubs at various locations across the country – work to develop innovative technologies that help keep Americans healthy. But as start-ups, they often have fewer resources with which to understand and navigate how to get their products approved. Some have to shut down while still going through the lengthy regulatory process – costing them money, and costing the public potentially lifesaving technologies.
“Life science start-ups need a helping hand to understand the regulatory process on their way to saving lives,” said Swalwell, whose Bay Area district is part of that region’s thriving life-sciences innovation hub. “Because developing medical technology often takes a lot of money, and many start-ups don’t earn revenue until their products are on the market, a long and complicated approval process can cause the start-ups to fold early. More direct outreach from the Food and Drug Administration could help a lot.”
The idea came from a meeting Swalwell had last year as chairman of Future Forum – a group of 26 young House Members focused on issues and opportunities for millennial Americans – with start-up executives at QB3, the University of California’s hub for innovation and entrepreneurship in the life sciences.
The letter to the Appropriations Subcommittee on Agriculture, Rural Development, FDA, and Related Agencies urges that the committee’s budget report include language directing the FDA to study putting staff in satellite offices located in life-science cluster areas to conduct this vital educational outreach.
“These firms are at the forefront of research and development of treatments that will be the next medical breakthroughs, help save lives, and reduce health care costs,” the letter says. “Even where the FDA has local offices, many in the life sciences community are not aware of its presence in their area. We believe there must be greater direct outreach in life sciences hubs to demystify both the FDA’s regulatory process and organizational structure, and ensure their groundbreaking treatments can reach patients in need.”
Click here to read the letter in its entirety.