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H.R. 5247

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

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.

Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 367.

Rep. Fitzpatrick, Brian K. [R-PA-8](R-PA)Sponsor
44 cosponsors1 D43 R
44cosponsors1committees29actions2related bills8subjects
  1. Calendars

    Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 367.

  2. Calendars

    Read the first time. Placed on Senate Legislative Calendar under Read the First Time.

  3. IntroReferral

    Received in the Senate.

  4. FloorH38310

    Motion to reconsider laid on the table Agreed to without objection.

  5. FloorH37100

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

  6. Floor8000

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

  7. FloorH36110

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

    Energy and Commerce Committee
  8. FloorH30000

    Considered as unfinished business. (consideration: CR H1748-1750)

  9. FloorH8D000

    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.

  10. FloorH8A000

    The previous question on the motion to recommit with instructions was ordered without objection.

  11. FloorH8D000

    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.

  12. FloorH36100

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

    Energy and Commerce Committee
  13. FloorH35000

    The previous question was ordered pursuant to the rule.

  14. FloorH8D000

    DEBATE - The House proceeded with one hour of debate on H.R. 5247.

  15. FloorH8D000

    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.

  16. FloorH30000

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

  17. FloorH1L220

    Rule H. Res. 787 passed House.

  18. FloorH1L210

    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.

  19. Committee

    Referred to the Subcommittee on Health.

    Health Subcommittee
  20. FloorH37300

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

  21. Floor9000

    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).

  22. FloorH30000

    Considered as unfinished business. (consideration: CR H1528-1529)

  23. FloorH37220

    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.

  24. FloorH8D000

    DEBATE - The House proceeded with forty minutes of debate on H.R. 5247.

  25. FloorH30000

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

  26. FloorH30300

    Mr. Walden moved to suspend the rules and pass the bill.

  27. IntroReferralH11100

    Referred to the House Committee on Energy and Commerce.

    Energy and Commerce Committee
  28. IntroReferralIntro-H

    Introduced in House

  29. IntroReferral1000

    Introduced in House

Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of … — Informed