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

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116th CONGRESS
  1st Session
                                H. R. 1520

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 5, 2019

  Ms. Eshoo introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 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 
                        60 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--
                                    ``(I) a list in alphabetical order 
                                of the official and proprietary name of 
                                each biological product for which a 
                                biologics license under subsection (a) 
                                or this subsection is in effect as of 
                                such date of enactment;
                                    ``(II) the date of licensing if the 
                                biological product is licensed after 
                                1981 and the number of the application 
                                which was approved; and
                                    ``(III) whether in vitro or in vivo 
                                bioequivalence studies, or both such 
                                studies, are required for applications 
                                filed under this subsection which will 
                                refer to the biological product 
                                published.
                            ``(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.--When patent 
                        information 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 
                        Secretary shall, in revisions made under clause 
                        (ii), include such information for such 
                        biological product.
                    ``(B) Date of publication.--A 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 published under 
                subparagraph (A) on the later of--
                            ``(i) the date of its licensing; or
                            ``(ii) the date of its publication in the 
                        list that--
                                    ``(I) was published under this 
                                section before the initial publication 
                                of the list under subparagraph (A); and
                                    ``(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.
                    ``(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--
                            ``(i) it shall be immediately removed from 
                        such list--
                                    ``(I) for the same period as the 
                                withdrawal or suspension; or
                                    ``(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.''.

SEC. 3. REVIEW AND REPORT ON TYPES OF BIOLOGICAL PRODUCT PATENTS 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) complete a review of, and formulate recommendations on, 
        the types of biological product patents that should be included 
        in 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) report such recommendations to the Congress.
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