Washington, D.C. — U.S. Senators Michael Bennet (D-CO) and Orrin Hatch (R-UT) this week introduced the Making Objective Drug Evidence Revisions for New (MODERN) Labeling Act. The bipartisan legislation would authorize the U.S. Food and Drug Administration (FDA) to modify outdated drug labels to reflect new evidence relevant to the drug and its use.
“Medical providers need the most up-to-date information to make the right health care decisions for their patients,” said Bennet. “We must ensure the FDA has the authority to update prescription drug information for older treatments using the latest clinical evidence. Passing this bipartisan legislation is an important step we can take to modernize prescribing in our health care system.”
“In an ideal world, a drug’s label would contain all available information healthcare professionals need to prescribe it effectively. Due to a variety of reasons, that is not always the case and physicians are sometimes left to consult outside sources for up-to-date prescribing information,” said Hatch. “I am pleased today that Senator Bennet joins me in providing the tools the FDA needs to better protect public health. I look forward to continuing to work with my colleagues, stakeholders, and the FDA to advance this policy into law.”
“The legislation Senators Hatch and Bennet are introducing today addresses a major public health issue,” said Jeff Allen, President & CEO of Friends of Cancer Research. “We have seen in recent studies that information about a drug’s optimal use evolves over time; however, the drug’s label frequently does not. By implementing a legislative remedy to the issue, patients and their physicians will have more accurate and relevant information so as to make informed decisions about the most important item: high quality patient treatment and care.”
Background
When a drug receives marketing approval by the FDA, the drug’s label represents the most authoritative source of drug-related information available to prescribers. However, the label may fall “out-of-date” as new information emerges from subsequent clinical trials or in the post-market setting. Drug sponsors are required to update a label when it becomes inaccurate, false, or misleading, but new scientific information regarding the “effectiveness” portion of a label, including information related to dosage and new uses, often is not incorporated.
Older drugs with expired patents are most likely to have outdated labels because the sponsors of these drugs, having lost market share to generic competitors, have few, if any, incentives to undertake the costly and time-consuming process of updating product labels. In many cases, the sponsor of an off-patent product may withdraw its drug from the market, which causes generic versions of that drug to rely on a label that cannot be readily updated. This is because, under current law, a generic drug is required to have the same label as its reference. Therefore, when a reference product is pulled from the market, the generic is unable to update its label.
The bill text is available HERE.