Congress 115 - HR 5247 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018

Sponsor

Cosponsors

Topics

Business records Civil actions and liability Drug safety, medical device, and laboratory regulation Drug therapy Government information and archives Health Long-term, rehabilitative, and terminal care Medical research Prescription drugs

Full Text

View Full Bill Text

Votes

Summary

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.

Actions

Apr 9, 2018

Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 367.
Mar 23, 2018

Read the first time. Placed on Senate Legislative Calendar under Read the First Time.
Mar 22, 2018

Received in the Senate.
Mar 21, 2018

Motion to reconsider laid on the table Agreed to without objection.
Mar 21, 2018

On passage Passed by recorded vote: 267 - 149 (Roll no. 121). (text: CR H1738-1739)
Mar 21, 2018

Passed/agreed to in House: On passage Passed by recorded vote: 267 - 149 (Roll no. 121).(text: CR H1738-1739)
Mar 21, 2018

On motion to recommit with instructions Failed by the Yeas and Nays: 182 - 233 (Roll no. 120).
Mar 21, 2018

Considered as unfinished business. (consideration: CR H1748-1750)
Mar 21, 2018

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.
Mar 21, 2018

The previous question on the motion to recommit with instructions was ordered without objection.
Mar 21, 2018

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.
Mar 21, 2018

Mr. Pallone moved to recommit with instructions to the Committee on Energy and Commerce. (text: CR H1746-1747)
Mar 21, 2018

The previous question was ordered pursuant to the rule.
Mar 21, 2018

DEBATE - The House proceeded with one hour of debate on H.R. 5247.
Mar 21, 2018

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.
Mar 21, 2018

Considered under the provisions of rule H. Res. 787. (consideration: CR H1738-1748)
Mar 20, 2018

Rule H. Res. 787 passed House.
Mar 19, 2018

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.
Mar 16, 2018

Referred to the Subcommittee on Health.
Mar 13, 2018

On motion to suspend the rules and pass the bill Failed by the Yeas and Nays: (2/3 required): 259 - 140 (Roll no. 102).
Mar 13, 2018

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).
Mar 13, 2018

Considered as unfinished business. (consideration: CR H1528-1529)
Mar 13, 2018

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.
Mar 13, 2018

DEBATE - The House proceeded with forty minutes of debate on H.R. 5247.
Mar 13, 2018

Considered under suspension of the rules. (consideration: CR H1521-1527; text of measure as introduced: CR H1521-1522)
Mar 13, 2018

Mr. Walden moved to suspend the rules and pass the bill.
Mar 13, 2018

Referred to the House Committee on Energy and Commerce.
Mar 13, 2018

Introduced in House

Amendments

Related Bills