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.
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.
Became Public Law No: 115-176.
Motion to reconsider laid on the table Agreed to without objection.
On motion to suspend the rules and pass the bill Failed by the Yeas and Nays: (2/3 required): 259 - 140 (Roll no. 102).
Roll Call #102 (House)Referred to the Subcommittee on Health.
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.
Rule H. Res. 787 passed House.
Considered under the provisions of rule H. Res. 787. (consideration: CR H1738-1748)
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.
DEBATE - The House proceeded with one hour of debate on H.R. 5247.
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The previous question was ordered pursuant to the rule.
Mr. Pallone moved to recommit with instructions to the Committee on Energy and Commerce. (text: CR H1746-1747)
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.
The previous question on the motion to recommit with instructions was ordered without objection.
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.
Considered as unfinished business. (consideration: CR H1748-1750)
On motion to recommit with instructions Failed by the Yeas and Nays: 182 - 233 (Roll no. 120).
Roll Call #120 (House)Passed/agreed to in House: On passage Passed by recorded vote: 267 - 149 (Roll no. 121).(text: CR H1738-1739)
Roll Call #121 (House)On passage Passed by recorded vote: 267 - 149 (Roll no. 121). (text: CR H1738-1739)
Roll Call #121 (House)Motion to reconsider laid on the table Agreed to without objection.
Received in the Senate.
Read the first time. Placed on Senate Legislative Calendar under Read the First Time.
Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 367.