[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"current-user-roles":3,"user-subscription":3,"bill:119-hr-843":4},null,{"bill":5,"indexable":155,"summaries":156,"cosponsors":162,"cosponsorSlugs":163,"actions":164,"amendments":183,"amendmentSponsorSlugs":184,"linkages":185,"sponsorSlug":186},{"statusDate":6,"sponsor":7,"updateDate":16,"cboCostEstimates":17,"originChamber":18,"congress":19,"isByRequest":20,"title":21,"createdAt":22,"committeeReports":23,"cosponsorCount":24,"onBehalfOfSponsor":3,"adminOverride":3,"amendmentCount":24,"actionCount":25,"popularTitle":3,"laws":3,"billType":26,"introducedDate":6,"committees":27,"congressGovUrl":28,"constitutionalAuthority":29,"policyArea":30,"deletedAt":3,"latestAction":31,"billNumber":33,"cosponsorCountIncludingWithdrawn":24,"status":34,"shortTitle":21,"officialTitle":35,"keyMilestoneCount":36,"subjects":37,"updatedAt":40,"policyAreaLower":41,"searchTokens":42,"committeeCodes":154},"2025-01-31",{"firstName":8,"lastName":9,"district":10,"fullName":11,"middleName":12,"state":13,"party":14,"bioguideId":15},"Nanette","Barragán","44","Rep. Barragán, Nanette Diaz [D-CA-44]","Diaz","CA","D","B001300","2025-03-28T17:46:13Z",[],"House",119,false,"Prompt Approval of Safe Generic Drugs Act","2026-05-11T14:46:45.788Z",[],0,3,"hr",[],"https:\u002F\u002Fwww.congress.gov\u002Fbill\u002F119th-congress\u002Fhouse-bill\u002F843","\u003Cpre>\n[Congressional Record Volume 171, Number 21 (Friday, January 31, 2025)]\n[House]\nFrom the Congressional Record Online through the Government Publishing Office [\u003Ca href=\"https:\u002F\u002Fwww.gpo.gov\">www.gpo.gov\u003C\u002Fa>]\nBy Ms. BARRAGAN:\nH.R. 843.\nCongress has the power to enact this legislation pursuant\nto the following:\nArticle I, Section 8 of the United States Constitution\n[Page H433]\n\u003C\u002Fpre>","Health",{"date":6,"text":32},"Referred to the House Committee on Energy and Commerce.",843,"in_committee","To amend the Federal Food, Drug, and Cosmetic Act to provide for the prompt approval of drugs when safety information is added to labeling, and for other purposes.",2,[38,39],"Drug safety, medical device, and laboratory regulation","Marketing and advertising","2026-05-22T15:50:32.745Z","health",[43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,10],"prompt","pr","pro","prom","promp","approval","ap","app","appr","appro","approv","approva","of","safe","sa","saf","generic","ge","gen","gene","gener","generi","drugs","dr","dru","drug","act","to","amend","am","ame","amen","the","federal","fe","fed","fede","feder","federa","food","fo","foo","and","cosmetic","co","cos","cosm","cosme","cosmet","cosmeti","provide","prov","provi","provid","for","when","wh","whe","safety","safet","information","in","inf","info","infor","inform","informa","informat","informati","informatio","is","added","ad","add","adde","labeling","la","lab","labe","label","labeli","labelin","other","ot","oth","othe","purposes","pu","pur","purp","purpo","purpos","purpose","rep","barragan","ba","bar","barr","barra","barrag","barraga","nanette","na","nan","nane","nanet","nanett","diaz","di","dia","ca",[],true,[157],{"versionCode":158,"actionDate":6,"actionDesc":159,"text":160,"updateDate":161},"00","Introduced in House","\u003Cp>\u003Cstrong>Prompt Approval of Safe Generic Drugs Act\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>This bill authorizes the Food and Drug Administration (FDA) to approve certain applications to market a generic drug despite the omission of certain safety information from the generic drug's labeling.\u003C\u002Fp>\u003Cp>Specifically, the FDA may not deem an abbreviated application for approval of a generic drug ineligible for approval solely because the drug's labeling omits safety information that is protected under another drug's patent or exclusivity protections. Similarly, a drug that is approved under this bill may not be considered mislabeled for lacking such safety information.\u003C\u002Fp>\u003Cp>Generally, an abbreviated application, for the purposes of this bill, is one that (1) uses required information from studies not conducted by the applicant; or (2) seeks approval of a drug that is, for drug approval purposes, a duplicate of an already-approved drug (i.e., a generic drug). Currently, the labeling for such a generic drug must generally be identical to that of the already-approved drug. This bill provides an exception to that requirement under the specified circumstances. \u003C\u002Fp>\u003Cp>For any drug approved under this bill, the FDA must require the drug's labeling to include any safety information that is necessary to assure safe use.\u003C\u002Fp>","2025-03-28T17:45:23Z",[],{},[165,174,180],{"actionDate":6,"actionDateTime":3,"text":32,"type":166,"actionCode":167,"sourceSystem":168,"committees":170,"recordedVotes":3,"calendarNumber":3,"sequenceIndex":24,"isKeyMilestone":20},"IntroReferral","H11100",{"code":36,"name":169},"House floor actions",[171],{"name":172,"systemCode":173},"Energy and Commerce Committee","hsif00",{"actionDate":6,"actionDateTime":3,"text":159,"type":166,"actionCode":175,"sourceSystem":176,"committees":3,"recordedVotes":3,"calendarNumber":3,"sequenceIndex":179,"isKeyMilestone":155},"Intro-H",{"code":177,"name":178},9,"Library of Congress",1,{"actionDate":6,"actionDateTime":3,"text":159,"type":166,"actionCode":181,"sourceSystem":182,"committees":3,"recordedVotes":3,"calendarNumber":3,"sequenceIndex":36,"isKeyMilestone":155},"1000",{"code":177,"name":178},[],{},[],"nanette-diaz-barragn"]