Medical device industry floats idea to pay user fees during shutdown

WASHINGTON – The trade group that represents dozens of Minnesota's medical technology businesses wants to pay user fees included in the unapproved federal budget to keep medical device reviews going at the U.S. Food and Drug and Administration (FDA) during the partial government shutdown.

The Advanced Medical Technology Association (AdvaMed) is shopping a legislative proposal that lets the device industry pay user fees that currently are not allowed in the shutdown.

The FDA is currently applying user fees paid under the last federal budget to review product-approval requests that were made before the shutdown, AdvaMed CEO Scott Whitaker told reporters Thursday. But any product-approval requests made since the shutdown began more than a month ago are not being considered.

The leftover user fees will run out in "two to three months," Whitaker said. With roughly 300 new device submissions each month the backlog grows quickly, he added.

"We're talking about new and innovative treatments," that could have an impact on patient care, Whitaker said.

Industry-paid user fees are a critical source of funding for the FDA product review process.

Greg Crist, vice president of public affairs at AdvaMed, said discussions of the trade group's proposed legislative language had taken place with lawmakers on "both sides of the aisle and both sides of the [Capitol] dome." But the trade group would not name the members it had talked to. It does not yet have a sponsor for its legislative proposal.

Whitaker called the device industry's attempt to pay new user fees to the FDA "completely nonpartisan."

He also said AdvaMed is "not assuming that this helps resolve the government shutdown."

Members of the Minnesota congressional delegation said they would like to study specifics of the AdvaMed plan, but expressed mixed feelings about the concept.

"We cannot have a piecemeal approach to this," said Democratic Sen. Tina Smith. "Right now, my top priority is that we reopen the government so people can get back to work and provide for their families, and so the FDA can do its job, too."

Republican Rep. Tom Emmer noted that "the medical device industry is a critical component of our state's economy and supports the health and well-being of patients around the nation." Emmer said he "will continue to explore all options with AdvaMed and the medical device community at large so that the FDA can process existing and new medical device reviews during this current government funding impasse."

Delays in the device-approval process is on the minds of some businesses in the med-tech rich Third Congressional District of Democratic Rep. Dean Phillips.

Phillips wants to study the AdvaMed proposal, a spokeswoman said. "But he is hearing from many constituents and businesses, including two businesses in Brooklyn Park that he toured over the weekend, who have concerns over the FDA's ability to do their job and keep things moving. It's certainly an issue that is on his radar."

Jim Spencer • 202-662-7432