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     &lt;p&gt;&lt;b&gt;Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 &lt;/b&gt;&lt;/p&gt; &lt;p&gt;This bill establishes 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 and there is an unmet need. &lt;/p&gt; &lt;p&gt;Specifically, the bill requires the product's sponsor to demonstrate, among other things, that (1) the product has been approved in one of the specified countries, (2) neither the FDA nor any of the specified countries have withdrawn approval for the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product.&lt;/p&gt; &lt;p&gt;The FDA may decline approval if the FDA determines that the product is not safe or effective. The FDA may condition reciprocal approval on the conduct of postmarket studies.&lt;/p&gt; &lt;p&gt;The FDA must issue a decision on whether to grant a request for reciprocal marketing approval within 30 days of receiving the request. &lt;/p&gt; &lt;p&gt;Congress may pass a joint resolution to grant reciprocal marketing approval of a product that the FDA declines to approve through the reciprocal process.&lt;/p&gt;
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2021-02-02
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2021-02-02
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2021-02-02
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2021-02-03T19:26:40Z
Referred to
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hsif14
hsif00
Standing
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Mark
Rep. Green, Mark E. [R-TN-7]
Green
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2021-02-23
TN
Congressional Research Service, Library of Congress
This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.
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2021-02-03
Referred to the Subcommittee on Health.
House
Health
2021-02-02
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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Identical bill
Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021
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R000614
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Chip
Rep. Roy, Chip [R-TX-21]
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Roy
R
TX
Congressional oversight Drug safety, medical device, and laboratory regulation
2021-02-02
Introduced in House
 <p><b>Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 </b></p> <p>This bill establishes 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 and there is an unmet need. </p> <p>Specifically, the bill requires the product's sponsor to demonstrate, among other things, that (1) the product has been approved in one of the specified countries, (2) neither the FDA nor any of the specified countries have withdrawn approval for the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product.</p> <p>The FDA may decline approval if the FDA determines that the product is not safe or effective. The FDA may condition reciprocal approval on the conduct of postmarket studies.</p> <p>The FDA must issue a decision on whether to grant a request for reciprocal marketing approval within 30 days of receiving the request. </p> <p>Congress may pass a joint resolution to grant reciprocal marketing approval of a product that the FDA declines to approve through the reciprocal process.</p>
2021-03-17T15:08:16Z
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2021-02-02T05:00:00Z
Introduced in House
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2021-02-03
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2021-02-02
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2021-02-02
Introduced in House
 <p><b>Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 </b></p> <p>This bill establishes 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 and there is an unmet need. </p> <p>Specifically, the bill requires the product's sponsor to demonstrate, among other things, that (1) the product has been approved in one of the specified countries, (2) neither the FDA nor any of the specified countries have withdrawn approval for the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product.</p> <p>The FDA may decline approval if the FDA determines that the product is not safe or effective. The FDA may condition reciprocal approval on the conduct of postmarket studies.</p> <p>The FDA must issue a decision on whether to grant a request for reciprocal marketing approval within 30 days of receiving the request. </p> <p>Congress may pass a joint resolution to grant reciprocal marketing approval of a product that the FDA declines to approve through the reciprocal process.</p>
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Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021
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Introduced in House
Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021
Short Title(s) as Introduced
IH
Introduced in House
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.
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2021-02-03
Referred to the Subcommittee on Health.