Shaheen Bill to Lower Prescription Drug Prices Included in Senate Health Committee’s Bipartisan Effort to Reduce Health Care Costs

May 28, 2019

(Washington, DC) – Last week, the Senate Committee on Health, Education, Labor & Pensions (HELP) released the Lower Health Care Costs Act of 2019 – bipartisan discussion draft legislation to reduce health care costs. The legislation includes U.S. Senator Jeanne Shaheen’s (D-NH) bipartisan bill with Senators Cory Gardner (R-CO), Bill Cassidy (R-LA) and Michael Bennet (D-CO) that would help lower prescription drug prices by increasing competition through improved oversight of the Food and Drug Administration’s (FDA) citizen petition process.

The citizen petition process allows interested stakeholders, including drug companies, to bring concerns to the FDA’s attention regarding pending applications. Currently, bad actors have discovered how to exploit this process by filing citizen petitions in order to delay the approval of generic competitors and extend their patent protections.

Shaheen’s bill – the Ensuring Timely Access to Generics Act of 2019 – ensures FDA’s ability to reject citizen petitions if they believe that the primary purpose of the petition is to delay the approval of an application, thereby increasing competition in the marketplace and lowering costs for patients. It also takes the additional step of requiring the Secretary of Health and Human Services (HHS) to establish procedures for referring a petitioner to the Federal Trade Commission (FTC) if they have reason to believe a petition was submitted with the primary purposes of delaying the approval of another application.  Shaheen’s bill also authorizes FDA to deny petitions when the organization or entity that filed the petition delayed filing the petition for an unreasonable period of time after the entity knew or should have known the clinical information that the petition was based on.

“Lowering prescription drug costs, and health care costs overall, needs to be at the top of Congress’ agenda. I’m very encouraged that the Senate health committee included my bipartisan legislation with Senators Gardner, Cassidy and Bennet to lower prescription drug prices, seizing an important opportunity for Democrats and Republicans to find common ground on such a critical issue,” said Shaheen. “This is a significant bipartisan priority that demands Congress’ immediate attention and action.”

Announced last week by Senate health committee Chairman Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA), the comprehensive health care legislation also includes a number of other bipartisan priorities that aim to deliver better health care outcomes and better health care experiences at lower costs.

Read the text of the draft bill here.