Creating Hope Reauthorization Act

Creating Hope Reauthorization Act

This bill reauthorizes a Food and Drug Administration (FDA) program that awards priority review vouchers to manufacturers of drugs that treat rare pediatric diseases. (A priority review voucher entitles the voucher holder to priority review of a single human drug application.)

Specifically, the bill reauthorizes the program through FY2024, but the FDA may award a voucher afterwards in certain instances.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4439 Introduced in House (IH)]

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116th CONGRESS
  1st Session
                                H. R. 4439

To amend the Federal Food, Drug, and Cosmetic Act to make permanent the 
   authority of the Secretary of Health and Human Services to issue 
  priority review vouchers to encourage treatments for rare pediatric 
                               diseases.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 20, 2019

  Mr. Butterfield (for himself, Mr. McCaul, Ms. Speier, Mr. Kelly of 
  Pennsylvania, Mr. Engel, Mr. Bilirakis, Ms. Kelly of Illinois, Mr. 
Hudson, Mr. Rush, and Mr. Mullin) introduced the following bill; which 
          was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to make permanent the 
   authority of the Secretary of Health and Human Services to issue 
  priority review vouchers to encourage treatments for rare pediatric 
                               diseases.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Creating Hope Reauthorization Act''.

SEC. 2. PROVIDING FOR PERMANENT AUTHORITY TO ISSUE PRIORITY REVIEW 
              VOUCHERS TO ENCOURAGE TREATMENTS FOR RARE PEDIATRIC 
              DISEASES.

    Section 529(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360ff(b)) is amended by striking paragraph (5).
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