H.R. 1520 — what changed

Section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)) is amended by adding at the end the following:

“(9) Public listing

“(A) In general

changed “(i) Initial publication—Not later than 60 180 days after the date of enactment of the Purple Book Continuity Act of 2019, the Secretary shall publish and make available to the public electronically—in a searchable, electronic format—

changed “(I) a list in alphabetical order of the official and proprietary nonproprietary or proper name of each biological product for which a biologics license under subsection (a) or this subsection is in effect effect, or that has been deemed to be licensed under this section pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009, as of such date of enactment;

changed “(II) the date of licensing if approval of the biological product is licensed after 1981 marketing application and the number of the application which was approved; number; and

changed “(III) whether in vitro or in vivo bioequivalence studies, the marketing or both such studies, are required licensure status of the biological product for applications filed which a biologics license under subsection (a) or this subsection which will refer is in effect or that has been deemed to be licensed under this section pursuant to section 7002(e)(4) of the biological product published.Biologics Price Competition and Innovation Act of 2009.

“(ii) Revisions—Every 30 days after the publication of the first list under clause (i), the Secretary shall revise the list to include each biological product which has been licensed under subsection (a) or this subsection during the 30-day period.

changed “(iii) Patent information—When patent information information—Not later than 30 days after a list of patents under subsection (l)(3)(A), or a supplement to such list under subsection (l)(7), has been provided by the reference product sponsor to the subsection (k) applicant respecting a biological product included on the list published under this subparagraph, the reference product sponsor shall provide such list of patents (or supplement thereto) and their corresponding expiry dates to the Secretary, and the Secretary shall, in revisions made under clause (ii), include such information for such biological product.product. Within 30 days of providing any subsequent or supplemental list of patents to any subsequent subsection (k) applicant under subsection (l)(3)(A) or (l)(7), the reference product sponsor shall update the information provided to the Secretary under this clause with any additional patents from such subsequent or supplemental list and their corresponding expiry dates.

changed “(B) Date “(iv) Listing of publication—A exclusivities—For each biological product for which a license is in effect under subsection (a) or this subsection shall, for purposes of this subsection, be considered to have been included on the list published under subparagraph (A) on this subparagraph, the later of—Secretary shall specify each exclusivity period that is applicable and has not concluded under paragraph (6) or paragraph (7).

changed “(i) “(B) Withdrawal or suspension of licensure—If the date licensing of a biological product was withdrawn or suspended for safety, purity, or potency reasons, it may not be published in the list under subparagraph (A). If the withdrawal or suspension occurred after its licensing; orpublication in such list, the reference product sponsor shall notify the Secretary that—

changed “(ii) the date of its publication in “(i) the list that—biological product shall be immediately removed from such list—

removed “(I) was published under this section before the initial publication of the list under subparagraph (A); and

removed “(II) was equivalent to the list published under section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act and comprised of patents associated with applications filed under subsection (a) of this section or under this subsection.

removed “(C) Withdrawal or suspension of licensure—If the licensing of a biological product was withdrawn or suspended for safety, purity, or potency reasons, it may not be published in the list under subparagraph (A). If the withdrawal or suspension occurred after its publication in such list—

removed “(i) it shall be immediately removed from such list—

“(I) for the same period as the withdrawal or suspension; or

added “(II) if the biological product has been withdrawn from sale, for the period of withdrawal from sale or, if earlier, the period ending on the date the Secretary determines that the withdrawal from sale is not for safety, purity, or potency reasons; and

removed “(II) if the listed drug has been withdrawn from sale, for the period of withdrawal from sale or, if earlier, the period ending on the date the Secretary determines that the withdrawal from sale is not for safety, purity, or potency reasons; and

“(ii) a notice of the removal shall be published in the Federal Register.”

Not later than 3 years after the date of enactment of this Act, the Secretary of Health and Human Services shall—