A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes.
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.
Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 367.
Referred to the Subcommittee on Crime, Terrorism, Homeland Security, and Investigations.
Referred to the Subcommittee on Crime, Terrorism, Homeland Security, and Investigations.
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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.
Considered under the provisions of rule H. Res. 905. (consideration: CR H4355-4366)
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.
DEBATE - The House proceeded with one hour of debate on S. 204.
The previous question was ordered pursuant to the rule.
Ms. Schakowsky moved to recommit with instructions to the Committee on Energy and Commerce. (CR H4363)
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.
Enacted as Public Law 115-176
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The previous question on the motion to recommit with instructions was ordered without objection.
On motion to recommit with instructions Failed by the Yeas and Nays: 187 - 231 (Roll no. 213).
Roll Call #213 (House)Passed/agreed to in House: On passage Passed by recorded vote: 250 - 169 (Roll no. 214).(text: CR H4355-4356)
Roll Call #214 (House)On passage Passed by recorded vote: 250 - 169 (Roll no. 214). (text: CR H4355-4356)
Roll Call #214 (House)Motion to reconsider laid on the table Agreed to without objection.
Presented to President.
Presented to President.
Signed by President.
Signed by President.
Became Public Law No: 115-176.
Became Public Law No: 115-176.