H.R. 4712 — what changed

“(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—

changed “(A)“(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

changed “(i) “(B) with respect to an application approved or a license issued after on or prior to the date of enactment of this subsection, upon not later than 60 days after such approval or issuance, date of enactment, that there is 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 will 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; orwithin 12 years of first marketing the drug.

changed “(ii) with respect to an application approved or a license issued on or prior to the date of enactment “(2) Considerations—For purposes of this subsection, not later than 60 days after such date subparagraphs (A) and (B) of enactment, that there was no reasonable expectation at paragraph (1), the time of such approval or issuance that Secretary and the cost sponsor of developing and making available in the United States such application for the drug designated for such a rare disease or condition would be recovered from sales described in the United States of such drug, taking into account all paragraph shall consider sales made or reasonably expected to be made without a time limitation; andfrom all drugs that—

removed “(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.

removed “(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

added “(B) are covered by the same designation under section 526.

removed “(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.”