U.S. Senators Mike Enzi, R-Wyo., and Michael Bennet, D-Colo., announced the introduction of their Making Objective Drug Evidence Revisions for New (MODERN) Labeling Act today. The bipartisan legislation would authorize the U.S. Food and Drug Administration (FDA) to modify outdated drug labels to reflect new evidence relevant to the drug and its use.
“It is important to make sure patients and providers have the most updated and relevant information about prescription drugs,” said Enzi. “Unfortunately, that’s not always the case. This legislation would help to ensure drug labels for older treatments are kept up-to-date so consumers have a better understanding of the prescription drugs they take.”
“We have to ensure that providers can treat their patients using the latest clinical evidence – not outdated information,” said Bennet. “Under this bill, the FDA would have the authority to update prescription drug information for older treatments which would also help drive the use of affordable generic therapies. I commend the HELP Committee for including this measure to modernize prescribing in the Lower Health Care Costs Act of 2019.”
After a drug receives marketing approval by the FDA, its 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 However, the label may fall “out-of-date” as new information emerges from subsequent clinical trials or in the post-market setting.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Older drugs with expired patents are most likely to have outdated labels because the sponsors of these drugs, having lost market share to generic competitors, have few, if any, incentives to undertake the costly and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.
The MODERN Labeling Act would direct the FDA to identify and update drug labels with outdated information.
The bill text is available HERE.