“Expanding Access to Low Cost Generic Drugs Act” Takes Aim at Anti-Competitive Prescription Drug Practice Called “Pay-for-Delay"

U.S. Senator Tina Smith’s first standalone piece of legislation—the Expanding Access to Low Cost Generic Drugs Act—takes aim at a big pharma tactic that keeps affordable generic drugs out of the hands of Minnesota families and seniors.

Sen. Smith’s bill, which she introduced today and is similar to a policy endorsed by the Trump Administration, gets at the heart of a major concern facing Minnesota families and seniors right now: prescription drug prices. We’re at the point now where 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 actually pay money to keep those generics off the market—an anti-competitive tactic called “pay for delay.” The Expanding Access Act would take major steps towards eliminating this practice.

“Since becoming Senator, I’ve traveled around Minnesota to talk with families, seniors, and communities,” said Sen. Smith, a member of the Senate Health Committee. “In these conversations, the topic of high prescription drug prices almost always comes up. The amount of money that Minnesotans pay for medications is out of control—and not to mention unsustainable. My first bill addresses an anti-competitive loophole that big pharmaceutical companies exploit in order to force Americans into buying overpriced drugs. It’s a commonsense measure that’s similar to a policy supported by the Trump Administration, and I’m going to fight to make it bipartisan—because really, unless you’re the CEO of a big drug company, you shouldn’t be opposed to this idea.” 

Right now, when a drug manufacturer is first to apply to bring a generic drug to market, they get half a year of exclusive rights to sell that generic drug. However, big pharmaceutical companies will often fight to keep their monopoly by paying that generic manufacturer to not sell the more affordable version of the drug. Sen. Smith’s bill gives the Food and Drug Administration (FDA) the ability to act as a stronger federal watchdog over these agreements, and would bring affordable generic drugs to families and consumers more quickly. It does this by enabling the FDA to take away the 180-day generic drug exclusivity period from any generic company that enters into anti-competitive pay-for-delay settlements with brand-name drug manufacturers.

###

Issues