3.0.0 5247 2023-01-11T13:40:17Z 2023-01-11T13:40:17Z House HR 2018-03-13 115 [Congressional Record Volume 164, Number 44 (Tuesday, March 13, 2018)]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. FITZPATRICK:H.R. 5247.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8[Page H1543]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2018-03-16T20:09:16Z Referred to 2018-03-13T16:00:20Z Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 115 204 S 2018-05-30 Became Public Law No: 115-176. Related bill CRS Providing for consideration of the bill (H.R. 4566) to amend the Dodd-Frank Wall Street Reform and Consumer Protection Act to provide relief to nonbanks from certain stress test requirements under such Act; providing for consideration of the bill (H.R. 5247) to authorize the use of eligible investigational drugs by eligible patients who have been diagnosed with a stage of a disease or condition in which there is reasonable likelihood that death will occur within a matter of months, or with another eligible illness, and for other purposes; and for other purposes. 115 787 HRES 2018-03-20 Motion to reconsider laid on the table Agreed to without objection. 14:19:17 Procedurally-related House 2018-04-09 Senate Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 367. Calendars 2018-03-23 Senate Read the first time. Placed on Senate Legislative Calendar under Read the First Time. Calendars 2018-03-22 Senate Received in the Senate. IntroReferral 2018-03-21 21:54:20 Motion to reconsider laid on the table Agreed to without objection. Floor H38310 2 House floor actions 2018-03-21 21:54:18 On passage Passed by recorded vote: 267 - 149 (Roll no. 121). (text: CR H1738-1739) Floor H37100 2 House floor actions 121 https://clerk.house.gov/evs/2018/roll121.xml House 115 2018-03-22T01:54:18Z 2 2018-03-21 21:54:18 Passed/agreed to in House: On passage Passed by recorded vote: 267 - 149 (Roll no. 121).(text: CR H1738-1739) Floor 8000 9 Library of Congress 121 https://clerk.house.gov/evs/2018/roll121.xml House 115 2018-03-22T01:54:18Z 2 2018-03-21 21:44:35 On motion to recommit with instructions Failed by the Yeas and Nays: 182 - 233 (Roll no. 120). Floor H36110 2 House floor actions hsif00 Energy and Commerce Committee 120 https://clerk.house.gov/evs/2018/roll120.xml House 115 2018-03-22T01:44:35Z 2 2018-03-21 21:16:16 Considered as unfinished business. (consideration: CR H1748-1750) Floor H30000 2 House floor actions 2018-03-21 14:08:01 POSTPONED PROCEEDINGS - At the conclusion of debate on the Pallone motion to recommit with instructions, the Chair put the question on the motion and by voice vote announced that the ayes had prevailed. Mr. Pallone demanded the yeas and nays, and the Chair postponed further proceedings on the motion to recommit until later in the legislative day. Floor H8D000 2 House floor actions 2018-03-21 14:07:51 The previous question on the motion to recommit with instructions was ordered without objection. Floor H8A000 2 House floor actions 2018-03-21 14:01:07 DEBATE - The House proceeded with 10 minutes of debate on the Pallone motion to recommit with instructions. The instructions contained in the motion seek to report the same back to the House forthwith with an amendment to require the Food and Drug Administration (FDA) to issue guidance describing how the agency will use expanded access outcomes when considering and evaluating investigational products for full approval. Additionally, the motion seeks to provide liability protection to manufacturers, physicians, and hospitals offering a product under expanded access, as long as the entity is in compliance with current federal law, and it also increases transparency in the FDAs expanded access program. Floor H8D000 2 House floor actions 2018-03-21 14:00:52 Mr. Pallone moved to recommit with instructions to the Committee on Energy and Commerce. (text: CR H1746-1747) Floor H36100 2 House floor actions hsif00 Energy and Commerce Committee 2018-03-21 13:59:53 The previous question was ordered pursuant to the rule. Floor H35000 2 House floor actions 2018-03-21 13:02:43 DEBATE - The House proceeded with one hour of debate on H.R. 5247. Floor H8D000 2 House floor actions 2018-03-21 13:01:37 The resolution provides for one hour of debate on each bill. The resolution makes in order only the further amendment to H.R. 4566 printed in the report. No further amendments on either bill are made in order. Section 3 of the resolution makes it in order to consider any resolution reported from the Rules Committee on the day it is reported through the legislative day of March 23, 2018. Section 4 grants suspension authority on the legislative days of March 22, 2018 and March 23, 2018. Section 5 of the resolution amends section 3(a) of H. Res. 5. Floor H8D000 2 House floor actions 2018-03-21 13:01:32 Considered under the provisions of rule H. Res. 787. (consideration: CR H1738-1748) Floor H30000 2 House floor actions 2018-03-20 14:19:16 Rule H. Res. 787 passed House. Floor H1L220 2 House floor actions 2018-03-19 19:08:52 Rules Committee Resolution H. Res. 787 Reported to House. The resolution provides for one hour of debate on each bill. The resolution makes in order only the further amendment to H.R. 4566 printed in the report. No further amendments on either bill are made in order. Section 3 of the resolution makes it in order to consider any resolution reported from the Rules Committee on the day it is reported through the legislative day of March 23, 2018. Section 4 grants suspension authority on the legislative days of March 22, 2018 and March 23, 2018. Section 5 of the resolution amends section 3(a) of H. Res. 5. Floor H1L210 2 House floor actions 2018-03-16 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2018-03-13 18:56:47 On motion to suspend the rules and pass the bill Failed by the Yeas and Nays: (2/3 required): 259 - 140 (Roll no. 102). Floor H37300 2 House floor actions 102 https://clerk.house.gov/evs/2018/roll102.xml House 115 2018-03-13T22:56:47Z 2 2018-03-13 18:56:47 Failed of passage/not agreed to in House: On motion to suspend the rules and pass the bill Failed by the Yeas and Nays: (2/3 required): 259 - 140 (Roll no. 102). Floor 9000 9 Library of Congress 102 https://clerk.house.gov/evs/2018/roll102.xml House 115 2018-03-13T22:56:47Z 2 2018-03-13 18:29:31 Considered as unfinished business. (consideration: CR H1528-1529) Floor H30000 2 House floor actions 2018-03-13 18:25:52 At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed. Floor H37220 2 House floor actions 2018-03-13 17:40:17 DEBATE - The House proceeded with forty minutes of debate on H.R. 5247. Floor H8D000 2 House floor actions 2018-03-13 17:40:14 Considered under suspension of the rules. (consideration: CR H1521-1527; text of measure as introduced: CR H1521-1522) Floor H30000 2 House floor actions 2018-03-13 17:40:04 Mr. Walden moved to suspend the rules and pass the bill. Floor H30300 2 House floor actions 2018-03-13 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2018-03-13 Introduced in House IntroReferral Intro-H 9 Library of Congress 2018-03-13 Introduced in House IntroReferral 1000 9 Library of Congress F000466 Rep. Fitzpatrick, Brian K. [R-PA-8] Brian Fitzpatrick R PA K. 8 N B001302 Rep. Biggs, Andy [R-AZ-5] Andy Biggs R AZ 5 2018-03-13 True G000568 Rep. Griffith, H. Morgan [R-VA-9] H. Griffith R VA Morgan 9 2018-03-13 True B001282 Rep. Barr, Andy [R-KY-6] Andy Barr R KY 6 2018-03-13 True B000213 Rep. Barton, Joe [R-TX-6] JOE BARTON R TX L. 6 2018-03-13 True B001243 Rep. Blackburn, Marsha [R-TN-7] Marsha Blackburn R TN 7 2018-03-13 True B001260 Rep. Buchanan, Vern [R-FL-16] Vern Buchanan R FL 16 2018-03-13 True C001103 Rep. Carter, Earl L. "Buddy" [R-GA-1] Earl Carter R GA L. "Buddy" 1 2018-03-13 True B001248 Rep. Burgess, Michael C. [R-TX-26] Michael Burgess R TX C. 26 2018-03-13 True C001105 Rep. Comstock, Barbara [R-VA-10] Barbara Comstock R VA 10 2018-03-13 True C001096 Rep. Cramer, Kevin [R-ND-At Large] Kevin Cramer R ND 0 2018-03-13 True C001048 Rep. Culberson, John Abney [R-TX-7] JOHN CULBERSON R TX ABNEY 7 2018-03-13 True B001273 Rep. Black, Diane [R-TN-6] Diane Black R TN 6 2018-03-13 True D000628 Rep. Dunn, Neal P. [R-FL-2] Neal Dunn R FL P. 2 2018-03-13 True F000464 Rep. Faso, John J. [R-NY-19] John Faso R NY J. 19 2018-03-13 True H001072 Rep. Hill, J. French [R-AR-2] J. Hill R AR French 2 2018-03-13 True G000579 Rep. Gallagher, Mike [R-WI-8] Mike Gallagher R WI 8 2018-03-13 True H001078 Rep. Handel, Karen C. [R-GA-6] Karen Handel R GA C. 6 2018-03-13 True H001053 Rep. Hartzler, Vicky [R-MO-4] Vicky Hartzler R MO 4 2018-03-13 True I000056 Rep. Issa, Darrell E. [R-CA-49] DARRELL ISSA R CA E. 49 2018-03-13 True L000587 Rep. Lewis, Jason [R-MN-2] Jason Lewis R MN 2 2018-03-13 True B001297 Rep. Buck, Ken [R-CO-4] Ken Buck R CO 4 2018-03-13 True L000564 Rep. Lamborn, Doug [R-CO-5] Doug Lamborn R CO 5 2018-03-13 True M001198 Rep. Marshall, Roger [R-KS-1] Roger Marshall R KS 1 2018-03-13 True M001187 Rep. Meadows, Mark [R-NC-11] Mark Meadows R NC 11 2018-03-13 True M001189 Rep. Messer, Luke [R-IN-6] Luke Messer R IN 6 2018-03-13 True B001274 Rep. Brooks, Mo [R-AL-5] Mo Brooks R AL 5 2018-03-13 True G000565 Rep. Gosar, Paul A. [R-AZ-4] Paul Gosar R AZ A. 4 2018-03-13 True R000598 Rep. Rothfus, Keith J. [R-PA-12] Keith Rothfus R PA J. 12 2018-03-13 True S001183 Rep. Schweikert, David [R-AZ-6] David Schweikert R AZ 6 2018-03-13 True S001191 Rep. Sinema, Kyrsten [D-AZ-9] Kyrsten Sinema D AZ 9 2018-03-13 True K000362 Rep. King, Steve [R-IA-4] Steve King R IA 4 2018-03-13 True Y000065 Rep. Yoho, Ted S. [R-FL-3] Ted Yoho R FL S. 3 2018-03-13 True W000814 Rep. Weber, Randy K., Sr. [R-TX-14] Randy Weber R TX K. 14 2018-03-13 True C001092 Rep. Collins, Chris [R-NY-27] Chris Collins R NY 27 2018-03-13 True Y000063 Rep. Yoder, Kevin [R-KS-3] Kevin Yoder R KS 3 2018-03-13 True H001045 Rep. Harper, Gregg [R-MS-3] Gregg Harper R MS 3 2018-03-13 True L000567 Rep. Lance, Leonard [R-NJ-7] Leonard Lance R NJ 7 2018-03-13 True A000372 Rep. Allen, Rick W. [R-GA-12] Rick Allen R GA W. 12 2018-03-13 True D000615 Rep. Duncan, Jeff [R-SC-3] Jeff Duncan R SC 3 2018-03-13 True H001056 Rep. Herrera Beutler, Jaime [R-WA-3] Jaime Herrera Beutler R WA 3 2018-03-13 True C000059 Rep. Calvert, Ken [R-CA-42] KEN CALVERT R CA 42 2018-03-14 False H001058 Rep. Huizenga, Bill [R-MI-2] Bill Huizenga R MI 2 2018-03-14 False R000592 Rep. Rokita, Todd [R-IN-4] Todd Rokita R IN 4 2018-03-19 False N000189 Rep. Newhouse, Dan [R-WA-4] Dan Newhouse R WA 4 2018-03-19 False Health Business records Civil actions and liability Drug safety, medical device, and laboratory regulation Drug therapy Government information and archives Long-term, rehabilitative, and terminal care Medical research Prescription drugs Health 00 2018-03-13 Introduced in House 2019-08-20T16:56:11Z Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018

This bill amends the Federal Food, Drug, and Cosmetic Act to exempt, from specified requirements and restrictions under that Act and other laws, the provision of certain unapproved, investigational drugs to a terminally ill patient who has exhausted approved treatment options and is unable to participate in a clinical trial involving the drugs. The manufacturer or sponsor of an eligible investigational drug must publish annual summaries on any use of the drug in accordance with these provisions.

The bill limits the liability of a sponsor, manufacturer, licensed physician, clinical investigator, or hospital that provides, or declines to provide, an eligible investigational drug to an eligible patient in accordance with the bill.

]]> Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 Display Title Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 Official Title as Introduced To authorize the use of eligible investigational drugs by eligible patients who have been diagnosed with a stage of a disease or condition in which there is reasonable likelihood that death will occur within a matter of months, or with another eligible illness, and for other purposes. Introduced in House IH Short Titles as Introduced Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 Short Titles as Passed House Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 H House Placed on Calendar Senate 2018-04-09T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115hr5247pcs/xml/BILLS-115hr5247pcs.xml Engrossed in House 2018-03-21T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115hr5247eh/xml/BILLS-115hr5247eh.xml Introduced in House 2018-03-13T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115hr5247ih/xml/BILLS-115hr5247ih.xml 2018-04-09 Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 367. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.