Fairness in Orphan Drug Exclusivity Act

Subjects: Health

Summary:  <p><b>Fairness in Orphan Drug Exclusivity Act</b></p> <p>This bill limits which orphan drugs may be granted a market exclusivity period by the Food and Drug Administration (FDA). (Generally, an orphan drug is one that is not economically viable because of the rarity of the disease that it treats; the sponsor of an FDA-designated orphan drug may be granted various incentives, such as a seven-year period in which the FDA may not grant market approval to a different sponsor for the same drug to treat the same disease.)</p> <p>Under this bill, if a drug is designated as an orphan drug on the basis that there is no reasonable expectation that the sponsor will recover the costs of developing and distributing the drug from U.S. sales, the drug shall be granted the seven-year exclusivity period only if the sponsor demonstrates that there is no reasonable expectation that it will recover such costs within its first 12 years of U.S. sales of the drug. </p> <p>When deciding whether an orphan drug meets this requirement, the FDA shall consider the sales of all drugs from the sponsor that are covered by the same orphan drug designation.</p>

<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 456 Introduced in House (IH)]

&lt;DOC&gt;






118th CONGRESS
  1st Session
                                H. R. 456

   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
limitations on exclusive approval or licensure of orphan drugs, and for 
                            other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            January 24, 2023

Mr. Carter of Georgia 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 with respect to 
limitations on exclusive approval or licensure of orphan drugs, and for 
                            other purposes.

    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 ``Fairness in Orphan Drug Exclusivity 
Act''.

SEC. 2. LIMITATIONS ON EXCLUSIVE APPROVAL OR LICENSURE OF ORPHAN DRUGS.

    Section 527 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360cc) is amended--
            (1) in subsection (a), by striking ``Except as provided in 
        subsection (b)'' and inserting ``Except as provided in 
        subsection (b) or (f)''; and
            (2) by adding at the end the following:
    ``(f) Limitations on Exclusive Approval, Certification, or 
License.--
            ``(1) In general.--For a drug designated under section 526 
        for a rare disease or condition pursuant to the criteria set 
        forth in subsection (a)(2)(B) of such section, the Secretary 
        shall not grant, recognize, or apply exclusive approval or 
        licensure under subsection (a), and, if such exclusive approval 
        or licensure has been granted, recognized, or applied, shall 
        revoke such exclusive approval or licensure, unless the sponsor 
        of the application for such drug demonstrates with respect to 
        an application approved or a license issued after the date of 
        enactment of this subsection, upon such approval or issuance, 
        that there is no reasonable expectation at the time of such 
        approval or issuance that the cost of developing and making 
        available in the United States such drug for such disease or 
        condition will be recovered from sales in the United States of 
        such drug, taking into account all sales made or reasonably 
        expected to be made within 12 years of first marketing the 
        drug.
            ``(2) Considerations.--For purposes of paragraph (1), the 
        Secretary and the sponsor of the application for the drug 
        designated for a rare disease or condition described in such 
        paragraph shall consider sales from all drugs that--
                    ``(A) are developed or marketed by the same sponsor 
                or manufacturer of the drug (or a licensor, predecessor 
                in interest, or other related entity to the sponsor or 
                manufacturer); and
                    ``(B) are covered by the same designation under 
                section 526.
            ``(3) Criteria.--No drug designated under section 526 for a 
        rare disease or condition pursuant to the criteria set forth in 
        subsection (a)(2)(B) of such section shall be eligible for 
        exclusive approval or licensure under this section unless it 
        met such criteria under such subsection on the date on which 
        the drug was approved or licensed.''.
                                 &lt;all&gt;
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