Political Quotes

“Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise today in support of H.R. 5668. This is the MODERN Labeling Act, and I want to thank our colleagues, Representatives Guthrie and Matsui, for their leadership on this important legislation which will allow the FDA to require modifications be made to outdated labeling for generic drugs. Now, while drug manufacturers are required to update a label when it becomes inaccurate, false, or misleading, there is no such requirement when new scientific information indicates there may be a new use for the product. Generic drugs are generally required to have the same labeling as the brand drug they reference; however, once the brand drug is no longer on the market, the generic manufacturer is actually prohibited from updating their label to reflect the most accurate, up-to-date information, information that is often discovered through postmarket use. So the inability to update labeling can result in information gaps for providers and patients when discussing treatments. For example, it has been estimated that more than half, Mr. Speaker-- half--of all uses of cancer drugs are off-label, meaning the drug is used for a disease or medical condition that it is not approved to treat. Many of these uses are widely accepted in the medical community and based on the most up-to-date scientific evidence; however, they are not reflected in FDA-approved labeling. So H.R. 5668 would help.…”