The Senate is, right now, debating what may be the most important piece of health policy it passes all year.
FDASIA is a new acronym, not to mention a pretty clunky one (congressional staffers are, reportedly, still trying to figure out how to pronounce it). Its policies, however, stretch back to the mid-1990s, when pharmaceutical firms were getting frustrated with the long wait times for drug approvals. The FDA said it didn’t have enough resources to move any faster. So pharmaceuticals settled on a system in which they would pay a “user fee” to help expedite the process.
Research suggests that the resulting law — known as the Prescription Drug User Fee Act — has worked: The FDA increased its reviewer staff by 77 percent and drug approval times dropped from 27 months to 14 months over the first eight years of the act, according to the GAO. Drugs in the United States now get reviewed two months faster than in Canada or Europe, according to a study published in this week’s New England Journal of Medicine.
FDASIA is the Senate’s latest incarnation of that user-fee legislation, which must be reauthorized every five years. Funding for the current law runs out in September. (The House has a separate bill that’s relatively similar.)
Both bills preserve what’s already happening in pharmaceutical regulation while making some key additions. FDASIA would, for the first time, assess a $1.5 billion user fee over five years on generic pharmaceutical makers, meant to pay for more reviewers for their products (while most new drugs are reviewed in 10 months, it takes three times as long to move a generic through the system).
The bill would also require drug manufacturers to notify the federal government of an impending slowdown in drug production, meant to address the number of drug shortages that has spiked in recent years.
FDASIA isn’t without its critics: Consumer groups have contended that some of the patient safety measures, specifically for medical devices, are too weak, potentially allowing unsafe devices to be marketed, although they have been swayed by new protections added in the course of the congressional debate.
The user-fee legislation looks to have a lot of momentum right now: The House version passed out of the Energy and Commerce Committee unanimously last week and, just today, the Senate bill, co-sponsored by Sens. Tom Harkin (D-Iowa) and Mike Enzi (R-Wyo.) got an endorsement from the White House. The Office of Budget and Management put out a statement noting that it “strongly supports” the bill. For all the talk of Congress not doing much, it looks to be on the verge of passing a crucial health policy provision that just about every legislator thinks is a good idea.