Fairness in Orphan Drug Exclusivity Act

Bill: 116-hr-4712
Sponsor: full_name: Rep. Dean, Madeleine [D-PA-4]
Introduced: 2019-10-17
Policy area: Health
Subjects: Competition and antitrust

Drug safety, medical device, and laboratory regulation

Licensing and registrations

Marketing and advertising

Prescription drugs
Latest action: action_date: 2020-11-18
text: Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:
action_date: 2019-10-17
action_desc: Introduced in House
text: <p><b>Fairness in Orphan Drug Exclusivity Act</b><br /></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>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.</p>

action_date: 2020-11-16
action_desc: Reported to House
text: <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 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. </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>

action_date: 2020-11-17
action_desc: Passed House
text: <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 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. </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>

tv_txt: I 116th CONGRESS 1st Session H. R. 4712 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.

1. Short title This Act may be cited as the Fairness in Orphan Drug Exclusivity Act . 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.

tv_txt: I 116th CONGRESS 2d Session H. R. 4712 IN THE HOUSE OF REPRESENTATIVES AN 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.

1. Short title This Act may be cited as the Fairness in Orphan Drug Exclusivity Act . 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. 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 November 17, 2020. Cheryl L. Johnson, Clerk.

tv_txt: IB Union Calendar No. 470 116th CONGRESS 2d Session H. R. 4712 [Report No. 116–572] 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 November 16, 2020 Additional sponsors: Mr. Tonko , Mr. Kim , Mr. Soto , and Mr. Taylor November 16, 2020 Reported with an amendment; committed to the Committee of the Whole House on the State of the Union and ordered to be printed Strike out all after the enacting clause and insert the part printed in italic For text of introduced bill, see copy of bill as introduced on October 17, 2019 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.

1. Short title This Act may be cited as the Fairness in Orphan Drug Exclusivity Act . 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.

November 16, 2020 Reported with an amendment; committed to the Committee of the Whole House on the State of the Union and ordered to be printed

tv_txt: IIB 116th CONGRESS 2d Session H. R. 4712 IN THE SENATE OF THE UNITED STATES November 18, 2020 Received; read twice and referred to the Committee on Health, Education, Labor, and Pensions AN 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.

1. Short title This Act may be cited as the Fairness in Orphan Drug Exclusivity Act . 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. 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 November 17, 2020. Cheryl L. Johnson, Clerk.