[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1520 Engrossed in House (EH)]

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116th CONGRESS
  1st Session
                                H. R. 1520

_______________________________________________________________________

                                 AN ACT


 
 To amend the Public Health Service Act to provide for the publication 
   of a list of licensed biological products, 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 ``Purple Book Continuity Act of 
2019''.

SEC. 2. PUBLIC LISTING.

    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.--
                            ``(i) Initial publication.--Not later than 
                        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 in a searchable, electronic format--
                                    ``(I) a list in alphabetical order 
                                of the nonproprietary or proper name of 
                                each biological product for which a 
                                biologics license under subsection (a) 
                                or this subsection is in 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;
                                    ``(II) the date of approval of the 
                                marketing application and the 
                                application number; and
                                    ``(III) the marketing or licensure 
                                status of the biological product for 
                                which a biologics license under 
                                subsection (a) or this subsection is in 
                                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.
                            ``(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.
                            ``(iii) Patent 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. 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.
                            ``(iv) Listing of exclusivities.--For each 
                        biological product included on the list 
                        published under this subparagraph, the 
                        Secretary shall specify each exclusivity period 
                        that is applicable and has not concluded under 
                        paragraph (6) or paragraph (7).
                    ``(B) 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, the reference product sponsor 
                shall notify the Secretary that--
                            ``(i) the biological product shall be 
                        immediately removed from such list--
                                    ``(I) for the same period as the 
                                withdrawal or suspension; or
                                    ``(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
                            ``(ii) a notice of the removal shall be 
                        published in the Federal Register.''.

SEC. 3. REVIEW AND REPORT ON TYPES OF INFORMATION TO BE LISTED.

    Not later than 3 years after the date of enactment of this Act, the 
Secretary of Health and Human Services shall--
            (1) solicit public comment regarding the type of 
        information, if any, that should be added to or removed from 
        the list required by paragraph (9) of section 351(k) of the 
        Public Health Service Act (42 U.S.C. 262(k)), as added by 
        section 2; and
            (2) transmit to Congress an evaluation of such comments, 
        including any recommendations about the types of information 
        that should be added to or removed from the list.

            Passed the House of Representatives May 8, 2019.

            Attest:

                                                                 Clerk.
116th CONGRESS

  1st Session

                               H. R. 1520

_______________________________________________________________________

                                 AN ACT

 To amend the Public Health Service Act to provide for the publication 
   of a list of licensed biological products, and for other purposes.