Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017

Bill: 115-s-204
Sponsor: Sen. Johnson, Ron [R-WI]
Introduced: 2017-01-24 in the Senate
Policy area: Health
Subjects: Civil actions and liability
Drug safety, medical device, and laboratory regulation
Drug therapy
Health technology, devices, supplies
Long-term, rehabilitative, and terminal care
Prescription drugs
Product safety and quality

Summary:
action_date: 2017-01-24
text: 

Trickett Wendler Right to Try Act of 2017

 
This bill requires the federal government to allow unrestricted manufacturing, distribution, prescribing, and dispensing of experimental drugs, biological products, and medical devices that are: (1) intended to treat a patient who has been diagnosed with a terminal illness, and (2) authorized by state law. The federal government must allow unrestricted possession and use of such treatments by patients certified by a physician as having exhausted all other treatment options.
 
A manufacturer, distributor, prescriber, dispenser, possessor, or user of such a treatment has no liability regarding the treatment.
 
The outcome of manufacture, distribution, prescribing, dispensing, possession, or use of such a treatment may not be used by a federal agency to adversely impact review or approval of the treatment.
 
The treatment must: (1) have successfully completed a phase 1 (initial, small scale) clinical trial; (2) remain under investigation in a clinical trial approved by the Food and Drug Administration; and (3) not be approved, licensed, or cleared for sale under the Federal Food, Drug, or Cosmetic Act or the Public Health Service Act.
 
 

action_date: 2017-08-03
text: 

Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017

 
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 report annually to the Food and Drug Administration (FDA) on any use of the drug in accordance with these provisions. The FDA shall post an annual summary report of such use on its website.
 
The bill limits the liability of a sponsor, manufacturer, prescriber, or dispenser that provides, or declines to provide, an eligible investigational drug to an eligible patient in accordance with the bill.
 


action_date: 2018-05-22
text: 

Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017

 
(Sec.2)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 report annually to the Food and Drug Administration (FDA) on any use of the drug in accordance with these provisions. The FDA shall post an annual summary report of such use on its website.
 
The bill limits the liability of a sponsor, manufacturer, prescriber, or dispenser that provides, or declines to provide, an eligible investigational drug to an eligible patient in accordance with the bill.
 


action_date: 2018-05-30
text: 

Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017

 
(Sec.2)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 report annually to the Food and Drug Administration (FDA) on any use of the drug in accordance with these provisions. The FDA shall post an annual summary report of such use on its website.
 
The bill limits the liability of a sponsor, manufacturer, prescriber, or dispenser that provides, or declines to provide, an eligible investigational drug to an eligible patient in accordance with the bill.
 



Legislative actions:
action_date: 2018-05-30
text: Became Public Law No: 115-176.
action_date: 2018-05-30
text: Became Public Law No: 115-176.
action_date: 2018-05-30
text: Signed by President.
action_date: 2018-05-30
text: Signed by President.
action_date: 2018-05-24
text: Presented to President.
action_date: 2018-05-24
text: Presented to President.
action_date: 2018-05-22
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2018-05-22
text: On passage Passed by recorded vote: 250 - 169 (Roll no. 214). (text:  CR H4355-4356)
action_date: 2018-05-22
text: Passed/agreed to in House: On passage Passed by recorded vote: 250 - 169 (Roll no. 214).(text:  CR H4355-4356)
action_date: 2018-05-22
text: On motion to recommit with instructions Failed by the Yeas and Nays: 187 - 231 (Roll no. 213).
action_date: 2018-05-22
text: The previous question on the motion to recommit with instructions was ordered without objection.
action_date: 2018-05-22
text: DEBATE - The House proceeded with 10 minutes of debate on the motion to recommit with instructions. The instructions contained in the motion seek to require the bill to be reported back to the House with an amendment to strike everything after section 1 and insert a completely new text.
action_date: 2018-05-22
text: Ms. Schakowsky moved to recommit with instructions to the Committee on Energy and Commerce. (CR H4363)
action_date: 2018-05-22
text: The previous question was ordered pursuant to the rule.
action_date: 2018-05-22
text: DEBATE - The House proceeded with one hour of debate on S. 204.
action_date: 2018-05-22
text: Rule provides for consideration of H.R. 5515, S. 204 and S. 2155. The resolution provides for one hour of general debate on H.R. 5515, S. 204 and S. 2155. The resolution provides for consideration of S. 2155 and S. 204 under a closed rule. Also, the resolution provides for consideration of H.R. 5515 under a structured rule and makes an amendment in the nature of a substitute consisting of the text of Rules Committee Print 115-70 considered as adopted.
action_date: 2018-05-22
text: Considered under the provisions of rule H. Res. 905. (consideration: CR H4355-4366)
action_date: 2018-05-21
text: Rules Committee Resolution H. Res. 905 Reported to House. Rule provides for consideration of H.R. 5515, S. 204 and S. 2155. The resolution provides for one hour of general debate on H.R. 5515, S. 204 and S. 2155. The resolution provides for consideration of S. 2155 and S. 204 under a closed rule. Also, the resolution provides for consideration of H.R. 5515 under a structured rule and makes an amendment in the nature of a substitute consisting of the text of Rules Committee Print 115-70 considered as adopted.
action_date: 2017-08-11
text: Referred to the Subcommittee on Health.
action_date: 2017-08-04
text: Referred to the House Committee on Energy and Commerce.
action_date: 2017-08-04
text: Received in the House.
action_date: 2017-08-03
text: Message on Senate action sent to the House.
action_date: 2017-08-03
text: Passed Senate with an amendment by Unanimous Consent.
action_date: 2017-08-03
text: Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
action_date: 2017-08-03
text: Measure laid before Senate by unanimous consent. (consideration: CR S4788-4789)
action_date: 2017-08-03
text: Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
action_date: 2017-08-03
text: Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
action_date: 2017-01-24
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2017-01-24
text: Introduced in Senate

Enacted as: number: 115-176