Bipartisan MODERN Labeling Act Included
Washington, DC – December 22, 2020 – Friends of Cancer Research (Friends) applauds the bipartisan work of the House and Senate to bolster the U.S. economy and support patients, physicians, and families during the COVID-19 pandemic.
We would also like to acknowledge the strong bipartisan work of the Members and Staff of the House Energy and Commerce Committee as well as the Senate HELP Committee and the leadership of Representatives Pallone (D-NJ), Walden (R-OR), Matsui (D-CA), Guthrie (R-KY) and Senators Bennet (D-CO), Alexander (R-TN), and Murray (D-WA) for including the Making Objective Drug Evidence Revisions for New Labeling Act or “MODERN Labeling Act” in the relief package.
“We are truly grateful for the work the members of both chambers, along with their staff, did to translate a study that was conducted by Friends into a legislative solution,” said Jeff Allen, President & CEO of Friends of Cancer Research. “We commend their bipartisan action to improve public health by including the MODERN Labeling Act in the relief package.”
MODERN responds to a public health issue identified by a Friends study and provides a solution to an issue impacting patients and their physicians around the country.
“The MODERN Labeling Act aids in maintaining up-to-date drug labels for certain generic drugs and restores the relevance of approved labeling to foster greater trust in medical products for physicians and patients,” said Ryan Hohman, VP – Public Affairs at Friends.
The legislation addresses the prevalence of outdated labels for drugs by giving the U.S. Food & Drug Administration (FDA) the authority to require updating labels to reflect new information relevant to the drug and its use when the approved label has been withdrawn. This Act also determines a process through which the FDA can identify labels to be updated, notice label holders, and allows for a process for label holders to submit modifications to the notice.
BACKGROUND
The work on MODERN has been years in the making, including congressional testimony on the topic. Previously, Friends hosted a congressional briefing on the topic of outdated labels. At the briefing, new data was presented showing that a striking number of FDA-approved prescription drug labels are out of date. The study, “Outdated Prescription Drug Labeling: How FDA-Approved Prescribing Information Lags Behind Real-World Clinical Practice,” was published in the peer-reviewed journal Therapeutic Innovation and Regulatory Science. The article showed that most FDA-approved cancer drug labels are missing critical information on drug effectiveness.
About Friends of Cancer Research
Friends of Cancer Research (Friends) is working to accelerate policy change, support groundbreaking science, and deliver new therapies to patients. We unite scientists, pharmaceutical companies, and policy makers with shared trust and guide them toward meaningful cooperation. This collaboration among partners from every healthcare sector ultimately drives advances in science, policy, and regulation that speed life-saving treatments to patients. For more information, please visit https://friendsofcancerresearch.org/.
