WASHINGTON, D.C. [6.14.22] – Today, U.S. Senator Tina Smith’s (D-MN) legislation—the Expanding Access to Low Cost Generic Drugs Act—was included with bipartisan support in a major funding bill. The legislation takes aim at a Big Pharma tactic that keeps affordable generic drugs out of the hands of Minnesota families and seniors.
“Since I came to the Senate, taking on big pharmaceutical companies and lowering prescription drug prices has been a top priority for me.” said Sen. Smith, a member of the Senate Health Committee. “That’s why the first bill I ever introduced addressed a loophole that big pharmaceutical companies exploit in order to force Americans into buying overpriced drugs. It’s a commonsense measure with bipartisan support—because really, unless you’re the CEO of a big drug company, you shouldn’t be opposed to this idea. I’m thrilled that it has taken this critical step forward.”
Sen. Smith’s bill gets at the heart of a major concern facing Minnesota families and seniors right now: prescription drug prices. Around 25 percent of Americans who take prescription drugs report difficulty affording them. And while generic drugs are often a much less expensive alternative to name-brand drugs, giant drug companies pay money to keep those generics off the market—an anti-competitive tactic called “parking.”
Parking happens when a brand-name manufacturer agrees not to sue the first company to create a generic version of that drug—a so called “first filer”—if the generic company agrees to delay bringing that drug to market. The Expanding Access to Low Cost Generic Drugs Act would take major steps towards eliminating this practice.
The bill would bring affordable generic drugs to families and consumers more quickly by allowing subsequent filers of generic drug applications to receive 180-day market exclusivity after a specified time-frame, and stop the parking behavior. This would change the incentive structure so that companies are encouraged to bring new generic drugs to market quickly, rather than to park their market exclusivities.
The legislation was included in the Senate Health Committee’s User Fee Agreement (UFAS), which funds the FDA and must be reauthorized every five years. More information on the bill can be found here.