{"database": "press", "table": "releases", "rows": [["https://dean.house.gov/2020/11/house-unanimously-passes-hr-4712-fairness-orphan-drug-exclusivity-act", "House Unanimously Passes The Fairness in Orphan Drug Exclusivity Act", "2020-11-18", "2020", "2020-11", "Democrat", "House", "PA", "Madeleine Dean", "D000631", "dean.house.gov", "dean", "https://dean.house.gov/press-releases", "scraper", "WASHINGTON \u2013 Today, the House voted unanimously passed H.R. 4712, the Fairness in Orphan Drug Exclusivity Act.\n\nThe bipartisan bill introduced by Rep. Madeleine Dean (PA-04), Marc Veasey (TX-33), Earl L. \u201cBuddy\u201d Carter (GA-01), and David McKinley (WV-01), closes a loophole that blocks pharmaceutical competition and prevents innovative treatments for opioid use disorder from coming to market.\n\n\u201cThe Fairness in Orphan Drug Exclusivity Act will create more treatment options for patients and providers, boost competition in the marketplace, and drive down the cost of new medicines,\u201d Rep. Dean said. \u201cThank you to my bipartisan colleagues for supporting this legislation. I am hopeful it will help save some struggling with opioid use disorders.\u201d\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 though they expect to easily recoup their R&D costs on the new version. This loophole is now being used to block new therapies from coming to the market that could aid in the opioid epidemic.\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\nThe Fairness in Orphan Drug Exclusivity Act is supported by AIDS United, Aimed Alliance, Young People in Recovery, No More ODs \u2013 The Savannah Harm Reduction Coalition, A Mother\u2019s Addiction Journey.\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.", 1, "2026-03-30T01:40:41Z", "2026-06-28T00:39:51Z"]], "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/2020/11/house-unanimously-passes-hr-4712-fairness-orphan-drug-exclusivity-act"], "units": {}, "query_ms": 1.5625469386577606, "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"}