{"database": "press", "table": "releases", "rows": [["https://dean.house.gov/2021/5/rep-dean-s", "Rep. Dean's Bipartisan Legislation Passes House \u2014 Bill will Allow New Treatments for Opioid Use Disorder", "2021-05-19", "2021", "2021-05", "Democrat", "House", "PA", "Madeleine Dean", "D000631", "dean.house.gov", "dean", "https://dean.house.gov/press-releases", "scraper", "WASHINGTON \u2013 Today, Rep. Dean\u2019s Fairness in Orphan Drug Exclusivity Act passed the House with an overwhelming bipartisan vote of 402-23.\n\nThe bill closes a loophole that could be used to block pharmaceutical competition and prevents innovative treatments for opioid use disorder from coming to market.\n\n\u201cIt was great to see the overwhelming bipartisan support for this legislation that will allow new treatments for those with opioid use disorder,\u201d Rep. Dean said. \"I am grateful to House leadership, Chairman Pallone, and Rep. Veasey (D-TX) for their work to get this bill passed with an overwhelming bipartisan majority \u2014 I look forward to its swift passage in the Senate and being signed by President Biden.\"\n\nBackground\n\nFor decades, The Orphan Drug Act of 1983 has provided incentives for prescription drug manufacturers to develop products to treat rare diseases \u2014 including an exclusive seven-year marketing right for therapies that receive an orphan drug indication.\n\nFor a drug to qualify for orphan designation, certain criteria must be met:\n\nThe disease or condition for which the drug is intended affects fewer than 200,000 people in the United States; or\n\nFor diseases or conditions affecting 200,000 or more people, there is no reasonable expectation that costs of research and development (R&D) of the drug can be recovered through sales.\n\nBecause opioid use disorder affects millions of Americans, the first criterion does not apply to new opioid medications.\n\nHowever, a loophole allows manufacturers to obtain seven-year market exclusivity under the second criterion by \u201cpiggybacking\u201d on the orphan drug status of an older drug \u2013 even if they expect to easily recoup their R&D costs on the new version.\n\nThe Fairness in Orphan Drug Exclusivity Act would close this loophole by making a minor update to the Orphan Drug Act \u2013 requiring all drugs that obtain seven years of market exclusivity under the second criterion to show that they have no reasonable expectation of recovering R&D costs through sales in the United States.\n\nRep. Madeleine Dean is a mother, grandmother, attorney, professor, former four-term member of the Pennsylvania House of Representatives, and U.S. Representative for the Fourth District of Pennsylvania.\n\n###", 1, "2026-03-30T01:40:41Z", "2026-04-06T19:49:40Z"]], "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://dean.house.gov/2021/5/rep-dean-s"], "units": {}, "query_ms": 0.781642971560359, "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"}