Title: Fairness in Orphan Drug Exclusivity Act
Policy area: Health

Summary:
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.)
Specifically, when determining whether to grant an exclusivity period to a drug that has orphan status due to low expected sales, the FDA shall consider the sales of all drugs from the sponsor that have the same core molecule or ion that is responsible for the drug's physiological or pharmacological action.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4712 Introduced in House (IH)]

<DOC>






116th CONGRESS
  1st Session
                                H. R. 4712

   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

                            October 17, 2019

   Ms. Dean (for herself, Mr. Veasey, Mr. Carter of Georgia, and Mr. 
  McKinley) 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.

    (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)(i) 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 
                without a time limitation; or
                    ``(ii) 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 without a time limitation; and
                    ``(B) annually for the duration of the 7-year 
                period described in subsection (a) with respect to the 
                drug, that there continues to be no reasonable 
                expectation 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 without a 
                time limitation.
            ``(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 for such disease or condition 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) contain the same active moiety as the drug, 
                regardless of whether or not the drugs also contain 
                different or additional active moieties.
            ``(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.
                                 <all>