```

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1520 Engrossed Amendment Senate (EAS)]

<DOC>
  
  
  
  
  
  
  
  
  
  

                  In the Senate of the United States,

                                                     December 10, 2020.
    Resolved, That the bill from the House of Representatives (H.R. 
1520) entitled ``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.'', do pass with the following

                               AMENDMENT:

             Strike all after the enacting clause and insert the 
      following:

SECTION 1. SHORT TITLE.

    The Act may be cited as the ``Purple Book Continuity Act of 2020''.

SEC. 2. BIOLOGICAL PRODUCT PATENT TRANSPARENCY.

    (a) In General.--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 2020, the 
                        Secretary shall publish and make available to 
                        the public in a searchable, electronic format--
                                    ``(I) a list of each biological 
                                product, by nonproprietary name (proper 
                                name), for which, as of such date of 
                                enactment, a biologics license under 
                                subsection (a) or this subsection is in 
                                effect, or that, as of such date of 
                                enactment, is deemed to be licensed 
                                under this section pursuant to section 
                                7002(e)(4) of the Biologics Price 
                                Competition and Innovation Act of 2009;
                                    ``(II) the date of licensure of the 
                                marketing application and the 
                                application number; and
                                    ``(III) with respect to each 
                                biological product described in 
                                subclause (I), the licensure status, 
                                and, as available, the marketing 
                                status.
                            ``(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 or deemed licensed under this 
                        section pursuant to section 7002(e)(4) of the 
                        Biologics Price Competition and Innovation Act 
                        of 2009.
                            ``(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 
                        under paragraph (6) or paragraph (7) for which 
                        the Secretary has determined such biological 
                        product to be eligible and that has not 
                        concluded.
                    ``(B) Revocation or suspension of license.--If the 
                license of a biological product is determined by the 
                Secretary to have been revoked or suspended for safety, 
                purity, or potency reasons, it may not be published in 
                the list under subparagraph (A). If such revocation or 
                suspension occurred after inclusion of such biological 
                product in the list published under subparagraph (A), 
                the reference product sponsor shall notify the 
                Secretary that--
                            ``(i) the biological product shall be 
                        immediately removed from such list for the same 
                        period as the revocation or suspension; and
                            ``(ii) a notice of the removal shall be 
                        published in the Federal Register.''.
    (b) 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 
        subsection (a); 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.

            Attest:

                                                             Secretary.
116th CONGRESS

  2d Session

                               H.R. 1520

_______________________________________________________________________

                               AMENDMENT
```