At a House Energy and Commerce Subcommittee on Health hearing titled, “Improving Safety and Transparency in America’s Food and Drugs,” Friends President and CEO, Jeff Allen, testified on the importance of updating medical product labels and the impact on patient safety and care. The hearing considered a series of bills addressing various issues related to the FDA, one of which was the recently introduced H.R. 5668, Making Objective Drug Evidence Revisions for New Labeling Act, or MODERN Labeling Act of 2020.
During opening statements, Representatives Doris Matsui (D-CA) and Brett Guthrie (R-KY) greeted the witnesses and spoke about their sponsorship of the MODERN Labeling Act, saying they were proud to introduce legislation aiming to solve the issue of outdated medical product labels.
Allen began his opening statement with a focus on the issue of outdated prescription drug labels and the proposal to help FDA ensure all drug labels contain the most accurate and up-to-date information; the MODERN Labeling Act of 2020. He went on to detail the issue futher, saying that product labeling can become outdated when high-quality scientific evidence is generated in the post-market setting, but the modified use isn’t added to the drug’s labeling. Drug manufacturers are not required by law to update their products’ labeling with new uses.
Noting a recent Friends study, he said that for almost every drug that Friends looked at – 79% to be exact – the clinical guidelines had more recommended uses than those described in the FDA label. Allen said that the bottom line is when sections of FDA-approved labeling become outdated, they may lose value for prescribers and fail to communicate essential information about drugs to patients and physicians. To read more about this study, Click HERE.
Friends President & CEO Jeff Allen Testifying at the House Energy and Commerce Subcommittee on Health
“The MODERN Labeling Act of 2020 addresses this problem of outdated labels by establishing a process for updating them to reflect new information relevant to the drug and its use.” – Jeff Allen, President & CEO, Friends of Cancer Research
Representatives went on to question the witnesses, with Rep. Kurt Schrader (D-OR) asking Allen why generic companies aren’t able to update their labels now. Allen said that in most cases they can if the reference product is still on the market, but if the reference product exits the market, as has been the case with many older drugs that have been widely studied, the sameness clause is gone and there is nothing that allows them to update their product labels.
Rep. Fred Upton (R-MI) continued questions on drug labeling, wondering if FDA had asked Congress previously to update these labels. Allen said that there have been some initiatives at the FDA Oncology Center of Excellence to review product labels that may need updating. Based on their work, 25% of the 44 products identified showed the FDA could not update without the enactment of MODERN.
Rep. Matsui, one of MODERN’s co-sponsors, said that a targeted solution is needed now to help patients and physicians make effective treatment decisions. She thanked Allen and Friends for our expert advocacy on the issue.
Friends has joined with other advocacy organizations in a letter of support for the MODERN Labeling Act of 2020. Click HERE to access the full letter. For more information on the issue of outdate prescription drug labels, please Click HERE.
