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To direct the Secretary of Health and Human Services to carry out a pilot project under which no more than 3 sponsors agree to evaluate the psychological and social distress experienced by patients participating in a clinical trial, conducted by the respective sponsor, of a drug or biological product that is intended to treat a serious or life-threatening disease or condition, and for other purposes.

USA115th CongressHR-2244| House 
| Updated: 5/5/2017
Leonard Lance

Leonard Lance

Republican Representative

New Jersey

Cosponsors (3)
Anna G. Eshoo (Democratic)Diana DeGette (Democratic)Yvette D. Clarke (Democratic)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Patient Experience in Research Act of 2017 This bill requires the Food and Drug Administration to carry out a pilot project under which sponsors of new drugs or biological products agree to evaluate: (1) the distress experienced by patients in clinical trials for medications intended to treat a serious condition, and (2) the effects of providing support to distressed patients on the outcome of a clinical trial. The user fee is waived for new drug applications that include data from such an evaluation.
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Timeline
Apr 28, 2017
Introduced in House
Apr 28, 2017
Referred to the House Committee on Energy and Commerce.
May 5, 2017
Referred to the Subcommittee on Health.
  • April 28, 2017
    Introduced in House
  • April 28, 2017
    Referred to the House Committee on Energy and Commerce.
  • May 5, 2017
    Referred to the Subcommittee on Health.

Health

Drug safety, medical device, and laboratory regulationMedical researchMental healthUser charges and fees

To direct the Secretary of Health and Human Services to carry out a pilot project under which no more than 3 sponsors agree to evaluate the psychological and social distress experienced by patients participating in a clinical trial, conducted by the respective sponsor, of a drug or biological product that is intended to treat a serious or life-threatening disease or condition, and for other purposes.

USA115th CongressHR-2244| House 
| Updated: 5/5/2017
Patient Experience in Research Act of 2017 This bill requires the Food and Drug Administration to carry out a pilot project under which sponsors of new drugs or biological products agree to evaluate: (1) the distress experienced by patients in clinical trials for medications intended to treat a serious condition, and (2) the effects of providing support to distressed patients on the outcome of a clinical trial. The user fee is waived for new drug applications that include data from such an evaluation.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Apr 28, 2017
Introduced in House
Apr 28, 2017
Referred to the House Committee on Energy and Commerce.
May 5, 2017
Referred to the Subcommittee on Health.
  • April 28, 2017
    Introduced in House
  • April 28, 2017
    Referred to the House Committee on Energy and Commerce.
  • May 5, 2017
    Referred to the Subcommittee on Health.
Leonard Lance

Leonard Lance

Republican Representative

New Jersey

Cosponsors (3)
Anna G. Eshoo (Democratic)Diana DeGette (Democratic)Yvette D. Clarke (Democratic)

Health Subcommittee, Energy and Commerce Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Drug safety, medical device, and laboratory regulationMedical researchMental healthUser charges and fees