Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018

Bill: 115-hr-5247
Sponsor: Rep. Fitzpatrick, Brian K. [R-PA-8]
Introduced: 2018-03-13 in the House
Policy area: Health
Subjects: 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

Summary:
action_date: 2018-03-13
text: 

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.


Legislative actions:
action_date: 2018-04-09
text: Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 367.
action_date: 2018-03-23
text: Read the first time. Placed on Senate Legislative Calendar under Read the First Time.
action_date: 2018-03-22
text: Received in the Senate.
action_date: 2018-03-21
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2018-03-21
text: On passage Passed by recorded vote: 267 - 149 (Roll no. 121). (text: CR H1738-1739)
action_date: 2018-03-21
text: Passed/agreed to in House: On passage Passed by recorded vote: 267 - 149 (Roll no. 121).(text: CR H1738-1739)
action_date: 2018-03-21
text: On motion to recommit with instructions Failed by the Yeas and Nays: 182 - 233 (Roll no. 120).
action_date: 2018-03-21
text: Considered as unfinished business. (consideration: CR H1748-1750)
action_date: 2018-03-21
text: 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.
action_date: 2018-03-21
text: The previous question on the motion to recommit with instructions was ordered without objection.
action_date: 2018-03-21
text: 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.
action_date: 2018-03-21
text: Mr. Pallone moved to recommit with instructions to the Committee on Energy and Commerce. (text: CR H1746-1747)
action_date: 2018-03-21
text: The previous question was ordered pursuant to the rule.
action_date: 2018-03-21
text: DEBATE - The House proceeded with one hour of debate on H.R. 5247.
action_date: 2018-03-21
text: 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.
action_date: 2018-03-21
text: Considered under the provisions of rule H. Res. 787. (consideration: CR H1738-1748)
action_date: 2018-03-20
text: Rule H. Res. 787 passed House.
action_date: 2018-03-19
text: 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.
action_date: 2018-03-16
text: Referred to the Subcommittee on Health.
action_date: 2018-03-13
text: On motion to suspend the rules and pass the bill Failed by the Yeas and Nays: (2/3 required): 259 - 140 (Roll no. 102).
action_date: 2018-03-13
text: 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).
action_date: 2018-03-13
text: Considered as unfinished business. (consideration: CR H1528-1529)
action_date: 2018-03-13
text: 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.
action_date: 2018-03-13
text: DEBATE - The House proceeded with forty minutes of debate on H.R. 5247.
action_date: 2018-03-13
text: Considered under suspension of the rules. (consideration: CR H1521-1527; text of measure as introduced: CR H1521-1522)
action_date: 2018-03-13
text: Mr. Walden moved to suspend the rules and pass the bill.
action_date: 2018-03-13
text: Referred to the House Committee on Energy and Commerce.
action_date: 2018-03-13
text: Introduced in House
action_date: 2018-03-13
text: Introduced in House