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Source: United States House of Representatives – Representative Abigail Spanberger (D-VA-07)

WASHINGTON, D.C. – U.S. Representative Abigail Spanberger today introduced bipartisan legislation to increase access to lower-cost prescription drugs and stop harmful practices that block new generic alternatives from entering the consumer market.

Biologic medicines are advanced therapies derived from living organisms, and they are used to treat many diseases and chronic conditions, including cancer, diabetes, and autoimmune diseases. Biologic manufacturers are able to protect these expensive products by using “patent thickets,” which can range from dozens to hundreds of patents. Many pharmaceutical companies design these thickets to block competition, and expensive litigation can deter competitors from offering lower-cost alternatives—known as “biosimilars.”

Spanberger’s Biologic Patent Transparency Act would take a first step in stopping this practice of “patent gaming” and would seek to level the playing field for biosimilar drugs. By increasing patent transparency in the prescription drug market, their legislation would promote competition between biosimilars and established biologic medicines—and these provisions would deliver biosimilar treatments to patients faster and help lower drug prices for American consumers.

“Across Central Virginia, I hear story after story about how high prescription drug costs are crippling the financial security of working families, retirees, and those with chronic conditions. For many of our neighbors, expanded access to lifesaving generic alternatives like biosimilars would help lower costs and give them new peace of mind—but the current level of complexity in the patent system makes it impossible for new drugs to compete,” said Spanberger. “Today, I’m proud to introduce this bipartisan bill, which would work to eliminate many of the barriers that make it difficult for biosimilars to enter the prescription drug market. I’d like to thank Congressman Reed for his partnership in introducing this bipartisan legislation—and I’ll keep working with Central Virginians to increase drug competition, lower prescription costs, and deliver improved access to high quality care to those across our district.”

Spanberger introduced the legislation with U.S. Representative Tom Reed (R-NY-23). Spanberger and Reed are both members of the bipartisan Problem Solvers Caucus. In June 2019, they both announced support for new principles to address rising prescription drug prices. These goals include fighting for greater transparency, competition, and affordability in the U.S. prescription drug marketplace. Spanberger serves as Co-Chair of the Caucus’ bipartisan, bicameral prescription drug task force, and Reed serves as Co-Chair of the overall Caucus.

“As the co-chair of the Diabetes Caucus, one of the things we noticed when conducting our recent insulin report was the myriad of patent abuses that prevented new biologics from coming to market. This bill goes a long way in addressing this critical issue,” said Reed. “As the father of a type 1 diabetic, I care about ensuring people with diabetes have access to fairly priced insulin, and I know this bill will help people across the United States to lower the cost of their prescription drugs by injecting competition into the market.”

The Biologic Patent Transparency Act would require companies to publicly disclose the web of patents that protect their biologics, making it easier for competitors to evaluate and plan for the development of generic versions of these drugs. Additionally, the bill would discourage late-filed patents and require the U.S. Food and Drug Administration to regularly publish information in its “Purple Book” on approved biologics—such as patents, exclusivity, and biosimilarity.

In March 2019, U.S. Senators Susan Collins (R-ME) and Tim Kaine (D-VA) introduced companion legislation in the U.S. Senate. The legislation was cosponsored by U.S. Senators Rob Portman (R-OH), Jeanne Shaheen (D-NH), Mike Braun (R-IN), and Debbie Stabenow (D-MI).

Click here to read the full bill text, and click here to read a summary of the bill.

BACKGROUND

In August 2019, Spanberger met with Central Virginia families, patients, providers, and pharmacists to learn more about the challenges caused by overpriced prescription drugs in Henrico County and to discuss potential legislative solutions to the drug affordability crisis.

Spanberger has long fought to expand access to affordable healthcare coverage and prescription drugs for all Central Virginians. Earlier this year, Spanberger introduced and led a bipartisan bill to hold pharmacy benefit managers accountable. In April 2019, this legislation passed unanimously out of the House Ways and Means Committee, and the bill passed out of the House Energy and Commerce Committee in July 2019.

Spanberger’s Biologic Patent Transparency Act builds on her work in the U.S. House to address the prescription drug affordability crisis, spur competition in the prescription drug industry, and increase transparency in drug pricing, including:

  • Increasing competition in the prescription drug marketplace: In May 2019, Spanberger joined a majority of the U.S. House in passing a bipartisan bill she cosponsored that would make it easier for Central Virginians to access lower-cost prescription drugs. The bill would prohibit pharmaceutical companies from participating in certain anti-competitive practices that block cheaper generic drugs from entering that market.
  • Giving Medicare the ability to negotiate drug prices: In January 2019, she helped introduce the Medicare Negotiation and Competitive Licensing Act, which would authorize the U.S. Department of Health and Human Services to negotiate directly with pharmaceutical providers within Medicare Part D to help lower costs.
  • Addressing additional factors that impact the prices of prescription drugs: Earlier this year, Spanberger helped introduce and pass landmark campaign finance and ethics reform legislation that would strengthen transparency in the U.S. political system and limit the influence of special interests—including pharmaceutical companies. During a press conference prior to the passage of the legislation, she shared the story of Central Virginians concerned about rising prescription drug prices—and she stressed why increased transparency would restore faith in the democratic process and the ability of Members of Congress to effect change on these issues. Click here to watch the full press conference.

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