Fairness in Orphan Drug Exclusivity Act
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.)
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 specifically within its first 12 years of U.S. sales of the drug. This requirement shall also apply retroactively to an orphan drug that was granted such an exclusivity period before this bill's enactment.
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.
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.

    (a) In General.--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--
                    ``(A) 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; or
                    ``(B) with respect to an application approved or a 
                license issued on or prior to the date of enactment of 
                this subsection, not later than 60 days after such date 
                of enactment, that there was 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 would 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 subparagraphs (A) 
        and (B) 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.''.
    (b) Rule of Construction.--The amendments made in subsection (a) 
shall apply to any drug that has been or is hereafter designated under 
section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bb) for a rare disease or condition pursuant to the criteria under 
subsection (a)(2)(B) of such section regardless of--
            (1) the date on which such drug is designated or becomes 
        the subject of a designation request under such section;
            (2) the date on which such drug is approved under section 
        505 of such Act (21 U.S.C. 355) or licensed under section 351 
        of the Public Health Service Act (42 U.S.C. 262) or becomes the 
        subject of an application for such approval or licensure; and
            (3) the date on which such drug is granted exclusive 
        approval or licensure under section 527 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 360cc) or becomes the subject 
        of a request for such exclusive approval or licensure.

SEC. 3. DETERMINATION OF BUDGETARY EFFECTS.

    The budgetary effects of this Act, for the purpose of complying 
with the Statutory Pay-As-You-Go Act of 2010, shall be determined by 
reference to the latest statement titled ``Budgetary Effects of PAYGO 
Legislation'' for this Act, submitted for printing in the Congressional 
Record by the Chairman of the House Budget Committee, provided that 
such statement has been submitted prior to the vote on passage.

            Passed the House of Representatives May 19, 2021.

            Attest:

                                             CHERYL L. JOHNSON,

                                                                 Clerk.
Fairness in Orphan Drug Exclusivity Act
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.
Fairness in Orphan Drug Exclusivity Act
Fairness in Orphan Drug Exclusivity Act
Fairness in Orphan Drug Exclusivity Act
Rep. Dean, Madeleine