{"database": "press", "table": "releases", "rows": [["https://web.archive.org/web/20140221004035/http://vanhollen.house.gov/news/documentsingle.aspx?DocumentID=360982", "Van Hollen, Leahy Lead Coalition of Lawmakers in Welcoming the FDA\u2019s Release of Proposed Rules To Protect Consumers Using Generic Drugs", "2013-11-08", "2013", "2013-11", "Democrat", "House", "MD", "Chris Van Hollen", "V000128", "web.archive.org", null, null, "legacy", "House Budget Committee Ranking Member Chris Van Hollen (D-Md.), Senate Judiciary Committee Chairman Patrick Leahy (D-Vt.) and a coalition of lawmakers on Friday welcomed the Food and Drug Administration\u2019s release of proposed rules to ensure that generic manufacturers of prescription drugs can update their warning labels to provide better\u00a0patient safety information to consumers.\nVan Hollen, Leahy, Senator Al Franken (D-Minn.), Senate HELP Committee Chairman Tom Harkin (D-Iowa), Senate Aging Committee Chairman Bill Nelson (D-Fla.), \u00a0and Representatives Henry Waxman (D-Calif.), Bruce Braley (D-Iowa), Matthew Cartwright (D-Pa.) and other lawmakers have long called for the FDA to act on this important patient safety issue.\u00a0 The rulemaking follows a Supreme Court case in which a patient who was gravely injured by a prescription drug was unable to seek relief from the drug\u2019s manufacturer because she took the generic version of the drug.\u00a0 The Court held that generic manufacturers could not be held responsible for inadequate labeling because they lack authority to update their warning labels, even if they become aware of new safety problems.\u00a0 That issue would be addressed by the proposed rule released Friday.\nLawmakers applauded the FDA\u2019s announcement:\n\u201cI applaud the FDA\u2019s action today to ensure that consumers are armed with the most accurate information about new risks and side effects of all drugs. This will help ensure that generic manufacturers have the ability to independently add or strengthen the warning on their products, like brand name manufacturers do. It is a critical change that we\u2019ve been fighting for, and it will improve safety and help Americans make the best decisions for their families,\u201d Van Hollen said.\n\u201cA consumer should not have her rights foreclosed simply because she takes the generic version of a prescription drug,\u201d Leahy said.\u00a0 \u201cI welcome this action by the Food and Drug Administration to ensure that generic manufacturers can improve their patient safety labels.\u00a0 Responsible brand-name and generic manufacturers alike should have the ability, and the obligation, to give doctors and patients the information they need to avoid injuries.\u201d\u00a0\n\u201cA senior in Minnesota may have no idea that a prescription drug they\u2019re taking could cause devastating complications because generic drug manufacturers aren\u2019t allowed to update their labels to accurately reflect all side effects or risks,\u201d Franken said. \u201cLast year, we introduced a bill to fix this problem. And today, after our urging, the FDA took a critical step forward to right this wrong. I\u2019ll be pushing to get the FDA\u2019s labeling fix implemented as soon as possible.\u201d\n\u201cConsumers and health care professionals should have access to the most up-to-date product labeling information, regardless of whether they choose to use a name-brand or a generic drug,\u201d Harkin said. \u201cI applaud the FDA for working to ensure that important generic drug safety information reaches consumers and health care professionals in the most timely manner possible, and hope this rule can be finalized quickly.\u201d\n\u201cThis new guidance will give consumers clear, safe and accurate drug information\u2014regardless of whether a drug is brand-name or generic,\u201d Nelson said.\n\u201cToday's action by FDA will not only allow patients and physicians to have access to the newest safety information about all drugs at the earliest possible time, but it will grant patients who take generic drugs\u00a0 the same right to access the courts as those who take a brand drug,\u201d Waxman said.\u00a0 \u201cI am also glad to see that FDA is carefully evaluating ways to preserve the \u2018sameness\u2019 principle between generic and brand drugs that has been so critical to the success of the U.S. generic drug system. Patients need to have confidence that the generic drugs are the same as their brand counterparts in all significant respects, including risk information on the drug labeling.\u201d\u00a0\n\u201cI\u2019m glad to see this important step forward for patient safety,\u201d Braley said. \u201cThis is a common sense solution to protect American patients who deserve to know the risks of the drugs they\u2019re taking. American consumers don't want\u00a0multiple sets of rules when it comes to the accuracy of drug labels. Today\u2019s announcement is an important step towards preventing the misuse of prescription drugs, and keeping Americans safer and healthier.\u201d\n\u201cI applaud the FDA\u2019s decision to allow generic drug manufacturers to update labels with the latest safety information,\u201d Cartwright said.\u00a0 \u201cThis proposal will help equip health care providers and consumers who depend on generic drugs with the best possible information to avoid adverse outcomes.\u201d\nThe lawmakers sent letters urging the FDA to act on this issue in June 2013, May 2012 and April 2012.\u00a0 Leahy, Franken and other members also introduced related legislation last year.\u00a0 Action on this issue has been supported by a broad coalition of patient safety and consumer groups, including the AARP, Public Citizen, Breast Cancer Action, and the National Women\u2019s Health Network.", 1, "2026-03-30T12:14:52Z", "2026-03-30T12:14:52Z"]], "columns": ["url", "title", "date", "year", "month", "party", "chamber", "state", "member_name", "bioguide_id", "domain", "scraper", "source", "date_source", "text", "has_text", "collected_at", "updated_at"], "primary_keys": ["url"], "primary_key_values": ["https://web.archive.org/web/20140221004035/http://vanhollen.house.gov/news/documentsingle.aspx?DocumentID=360982"], "units": {}, "query_ms": 1.5107619110494852, "source": "dwillis/congress-press", "source_url": "https://github.com/dwillis/congress-press", "license": "MIT", "license_url": "https://github.com/dwillis/congress-press/blob/main/LICENSE"}