Senator Smith’s “Expanding Access to Low-Cost Generics Act” Taking Aim at Anti-Competitive Prescription Drug Practice Called “Parking” Secures Bipartisan Support Thanks to Senator Braun

WASHINGTON, D.C. [12/18/19]—Today, U.S. Senators Tina Smith (D-Minn.) and Mike Braun (R-Ind.) introduced legislation to bring low-cost generics to market, increase competition and help American families and seniors access their medications.

The Expanding Access to Low-Cost Generics Act—which was the first standalone piece of legislation introduced by Sen. Smith—gets to the heart of a major concern families are facing right now: prescription drug prices. Nearly three in ten Americans report that they did not fill a prescription because it was too expensive. Anti-competitive behavior between brand name and generic drug manufacturers is delaying timely access to low-cost generic drugs. For example, “parking” is a practice that can occur when a brand name manufacturer agrees not to sue the first company that submits an application to create a generic version of that drug—a so-called “first filer”—as long as the generic company agrees to delay bringing that generic drug to market. This anti-competitive “parking” behavior creates a bottleneck in the number of generic products available on the market and drives up costs. Sen. Smith’s bill—which is now bipartisan thanks to Sen. Braun throwing his support behind the legislation—takes major steps toward eliminating this practice.

“I’ve traveled around Minnesota to talk with families, seniors, and communities, and the topic of prescription drug prices almost always comes up. The amount of money that Minnesotans pay for medications is out of control—and it’s not something families can, or should have to, sustain,” said Sen. Smith, a member of the Senate Health Committee. “This is the very first bill I introduced, and I pledged that I’d fight to make it bipartisan. I’m glad that my Republican colleague Senator Mike Braun from Indiana has joined me in this effort, and our bill addresses an anti-competitive loophole that big pharmaceutical companies exploit in order to force Americans into buying overpriced drugs. Unless you’re the CEO of a big drug company, you shouldn’t be opposed to this idea. We should get this over the finish line.”

“Everywhere I go in Indiana, the issue I hear about the most is the price of prescription drugs. That’s why I’m proud to sign on to Senator Smith’s bill to expand access to low-cost generic drugs and get more of these affordable prescription alternatives to market for Hoosiers,” said Sen. Braun.

Sens. Smith and Braun’s Expanding Access to Low-Cost Generics Act would solve this “parking” problem. Specifically, their bill would:

  • Address a statutory incentive that awards 180-days of market exclusivity to “first filers.” Sens. Smith and Brauns’ bill would allow generic companies that win their litigation against a brand-name company’s patent the ability to share market exclusivity with the first filer;
  • Change the incentive structure for generic companies seeking timely approval of their products. With the opportunity to receive sole 180-day market exclusivity for beating brand-name patents, and with evidence that these patents are weak and easily beat, this bill would encourage “first-filers” to rush to come to market rather than to “park” their products; and
  • Stop the bottleneck of generic products waiting to come to market. The legislation would encourage the 48 generic products who delayed their market entry due to arrangements with brand-name companies to instead come immediately to market and deliver real relief to Americans.

This legislation is supported by Families USA, the National Coalition on Health Care, the National Multiple Sclerosis Society, Apotex Corporation and the Blue Cross Blue Shield Association.

Sen. Smith has made bringing down the high cost of prescription drugs a top priority. In May of this year, a number of measures championed by Sen. Smith were included in a bipartisan package to address the rising cost of health care released by the Senate Health Committee. Her bipartisan Ensuring Innovation Act was added to the package, which was passed out of the Committee. In June, Sens. Smith introduced comprehensive legislation to hold large pharmaceutical companies accountable for high prices and bring down costs for Americans. Her Affordable Medications Act is a comprehensive set of reforms that would promote transparency by requiring pharmaceutical companies to disclose just how much money is going toward research and development, as well as marketing and pay for executives. The bill would also end the restriction that prevents the federal Medicare program from using its buying power to negotiate lower drug prices for its beneficiaries, and curb drug company monopoly practices that keep prices high and prevent less expensive generics from coming to the market. Also in June, Sens. Smith and Cramer introduced bipartisan legislation to establish emergency access to insulin, bring down the cost of insulin, and hold insulin manufacturers accountable for excessive increases in the price of the life-sustaining medicine. And just last month, Sens. Smith and Cramer—along with Sens. Tammy Baldwin (D-Wis.), Dick Durbin (D-Ill.), Cindy Hyde-Smith (R-Miss.) and Roger Wicker (R-Miss.)—introduced a bipartisan bill to create a national study to more fully understand the scope of the insulin affordability crisis in America. Finally, this week a key government funding package included Sen. Smith’s bipartisan Protecting Access to Biosimilars Act, which would codify the Food and Drug Administration’s (FDA) transition of regulating certain products—like insulin—from being regulated as a drug to instead being regulated as a biologic. The package made sure the FDA continues reviewing generic insulin applications after the FDA’s currently planned March 2020 cut-off date as well.   

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