WASHINGTON—Why is the nation's capital suddenly obsessed with biomedical innovation?
And why is the fruit of that obsession, the 21st Century Cures Act, moving like a greased pig through the usually deadlocked Congress—even as some experts warn it could undermine the Food and Drug Administration's ability to protect the public from unproven and potentially unsafe new drugs and medical devices?
Last week, the House Energy and Commerce Health Subcommittee unanimously approved the marked-up bill, sending it to the full committee, which is scheduled to consider it this week.
“This is a product deserving of the committee's support,” said Rep. Frank Pallone (D-N.J.), who led Democratic opposition to the bill only a few months ago.
Energy and Commerce Chairman Fred Upton (R-Mich.) says he wants to pass the bill later this year.
But key senators say they are working on their own bill, which won't be ready until at least the fall. There is no agreement yet on how to pay for the legislation's costs or on whether to boost FDA funding to help the agency handle its new obligations.
There also are divisions over whether to grant drugmakers longer market exclusivity for drugs treating rare diseases.
The sweeping bill would overhaul federal regulation of prescription drugs and medical devices. It also would provide significantly more funding to the National Institutes of Health, a move that brought Democrats onboard.
The overhaul bill would give the NIH $10 billion in additional mandatory funding over five years, as well as yearly increases, hiking the agency's budget by $8 billion by 2018 over current congressional appropriations.
Observers say nearly every sector of the healthcare industry has gotten involved in lobbying the bill.
According to the Senate's lobbying database, the number of groups listing the 21st Century Cures Act as a lobbying issue grew from 62 in the second quarter of last year to 222 in the first quarter of this year.
“It became a Christmas tree,” said Billy Wynne, of Thorn Run Partners, who has lobbied the bill. “Many people see it as the moonshot opportunity for lots of stuff,” another lobbyist said.