Legis Daily

A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for reciprocal marketing approval of certain drugs, biological products, and devices that are authorized to be lawfully marketed abroad, and for other purposes.

USA115th CongressS-2022| Senate 
| Updated: 10/26/2017
Ted Cruz

Ted Cruz

Republican Senator

Texas

Cosponsors (2)
Mike Lee (Republican)Ron Johnson (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to establish a reciprocal marketing approval process that allows for the sale of a drug, biological product, or medical device that has not been approved by the Food and Drug Administration (FDA) if the product is approved for sale in another country. For a product to be granted reciprocal marketing approval, the product's sponsor must submit a request to the FDA that demonstrates: (1) the product may be sold in at least one country from a specified list of countries, (2) the FDA and listed countries have not withdrawn approval of the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product. The FDA may: (1) require post-market studies of a product granted reciprocal marketing approval, or (2) decline to approve a product that is not safe and effective. The FDA must grant or decline reciprocal marketing approval not later than 30 days after receiving a request. During that period, the FDA and product sponsor must negotiate and finalize product labeling and, for a medical device, classify the device. Congress may pass a joint resolution to grant reciprocal marketing approval to a product that the FDA declines to approve through this process. User fees apply to requests for reciprocal marketing approval. The FDA must encourage the sponsors of potentially eligible products to request reciprocal marketing approval.
View Full Text

Suggested Questions

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

Timeline
Oct 26, 2017
Introduced in Senate
Oct 26, 2017
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • October 26, 2017
    Introduced in Senate


  • October 26, 2017
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Congressional oversightDrug safety, medical device, and laboratory regulation

A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for reciprocal marketing approval of certain drugs, biological products, and devices that are authorized to be lawfully marketed abroad, and for other purposes.

USA115th CongressS-2022| Senate 
| Updated: 10/26/2017
Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to establish a reciprocal marketing approval process that allows for the sale of a drug, biological product, or medical device that has not been approved by the Food and Drug Administration (FDA) if the product is approved for sale in another country. For a product to be granted reciprocal marketing approval, the product's sponsor must submit a request to the FDA that demonstrates: (1) the product may be sold in at least one country from a specified list of countries, (2) the FDA and listed countries have not withdrawn approval of the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product. The FDA may: (1) require post-market studies of a product granted reciprocal marketing approval, or (2) decline to approve a product that is not safe and effective. The FDA must grant or decline reciprocal marketing approval not later than 30 days after receiving a request. During that period, the FDA and product sponsor must negotiate and finalize product labeling and, for a medical device, classify the device. Congress may pass a joint resolution to grant reciprocal marketing approval to a product that the FDA declines to approve through this process. User fees apply to requests for reciprocal marketing approval. The FDA must encourage the sponsors of potentially eligible products to request reciprocal marketing approval.
View Full Text

Suggested Questions

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

Timeline
Oct 26, 2017
Introduced in Senate
Oct 26, 2017
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • October 26, 2017
    Introduced in Senate


  • October 26, 2017
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Ted Cruz

Ted Cruz

Republican Senator

Texas

Cosponsors (2)
Mike Lee (Republican)Ron Johnson (Republican)

Health, Education, Labor, and Pensions Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Congressional oversightDrug safety, medical device, and laboratory regulation