[Congressional Record Volume 165, Number 76 (Wednesday, May 8, 2019)]
[House]
[Pages H3485-H3486]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                       PURPLE BOOK CONTINUITY ACT

  Ms. ESHOO. Mr. Speaker, I move to suspend the rules and pass the bill 
(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, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 1520

       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

[[Page H3486]]

       (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.

  The SPEAKER pro tempore. Pursuant to the rule, the gentlewoman from 
California (Ms. Eshoo) and the gentleman from Texas (Mr. Burgess) each 
will control 20 minutes.
  The Chair recognizes the gentlewoman from California.


                             General Leave

  Ms. ESHOO. Mr. Speaker, I ask unanimous consent that all Members may 
have 5 legislative days in which to revise and extend their remarks and 
include extraneous material on H.R. 1520.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentlewoman from California?
  There was no objection.
  Ms. ESHOO. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise in support of H.R. 1520, the Purple Book 
Continuity Act of 2019. I am proud that my bipartisan legislation is 
being considered because it makes important updates and improvements to 
the Food and Drug Administration's Purple Book.
  I am also pleased that it is the first drug pricing bill to be 
considered by the full House this Congress. The legislation makes it 
easier for manufacturers to research and develop biosimilars, which are 
essentially generic biological products, and drive down prescription 
drug prices for the American people.
  The so-called ``Purple Book'' lists biological products, including 
biosimilars, that are licensed by the FDA. The Purple Book is a 
resource published by the FDA that includes very important information 
about existing products, about including designations that extend the 
product's exclusivity, and what active patents each product has.
  Today, the FDA is not statutorily required to publish this 
information, nor is the agency required to update the resource in a 
timely manner. The Purple Book also is not currently user-friendly and 
is burdensome for companies to access and use. Companies rely on the 
Purple Book to inform their research and development activities, and it 
is imperative that the resource is up-to-date and easily accessible, so 
they can move quickly to produce cost-saving biosimilar drugs which 
are, essentially, as I said previously, generic versions of the most 
complex, high-cost biological products.
  The Purple Book Continuity Act builds on previous work to promote the 
development of biosimilars and other alternatives to the highest-priced 
biologic products by putting necessary patent information into an 
easily accessible resource so companies can more efficiently and 
effectively direct their work to develop biosimilars.
  The Purple Book Continuity Act takes an important step to make it 
easier for the manufacturers to access patent and exclusivity 
information they need to invest in biosimilar development so that drug 
prices--the whole point is so that drug prices can be lowered for the 
American people.
  So the Purple Book Continuity Act passed the Energy and Commerce 
Committee by voice vote last month and, today, I urge my colleagues to 
support it.
  Mr. Speaker, I reserve the balance of my time.
  Mr. BURGESS. Mr. Speaker, I yield myself such time as I may consume.
  I rise today in support of H.R. 1520, the Purple Book Continuity Act. 
This bill has moved through regular order in the Energy and Commerce 
Committee and does, in fact, have broad bipartisan support. This may be 
only a small part of solving the problems of drug pricing, however, it 
is an important part of that question.
  Through the Biologics Price Competition and Innovation Act, Congress 
established a pathway for biosimilars to enter the therapeutic market 
so that patients would have more treatment options, more access to 
lifesaving medications, and lower healthcare costs.
  As the Food and Drug Administrator, at the time, Scott Gottlieb 
announced, there is a four-point plan to increase biosimilar 
availability. The plan would focus on increasing market competition by 
reducing delays to entry; improving the efficiency of biosimilar 
development; maximize the clarity of the regulatory process; and 
develop a communications strategy to promote biosimilars.
  The Purple Book plays an important role in biosimilar development. It 
lists the licensed biologic products, including any biosimilar or 
interchangeable biologic product, and any relevant exclusivity 
information. The Purple Book is not currently required by law and takes 
the form of two separate and sometimes cumbersome PDF files.
  H.R. 1520 codifies the Purple Book and requires the Food and Drug 
Administration to publish the information in a searchable format, 
similar to the Orange Book. This bill will make the Purple Book a more 
useful tool for developers of biosimilars, in addition to providers, 
payors, and patients.
  The Food and Drug Administration provided us with some important 
feedback that would ensure that the agency will be able to effectively 
implement this legislation should it become law. Enhancing the Purple 
Book is critical to the transparency of the relevant intellectual 
property protections, as well as other factors considered by the 
developers of biosimilars.
  So I certainly want to thank the chairwoman for her willingness to 
work with us and the agency on this important issue. I am pleased to 
cosponsor this bill, and I urge other Members to support it this 
afternoon.
  Mr. Speaker, I have no other speakers. I urge support of this bill 
upon passage, and I yield back the balance of my time.
  Ms. ESHOO. Mr. Speaker, I yield back the balance of my time.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentlewoman from California (Ms. Eshoo) that the House suspend the 
rules and pass the bill, H.R. 1520, as amended.
  The question was taken.
  The SPEAKER pro tempore. In the opinion of the Chair, two-thirds 
being in the affirmative, the ayes have it.
  Ms. ESHOO. Mr. Speaker, I object to the vote on the ground that a 
quorum is not present and make the point of order that a quorum is not 
present.
  The SPEAKER pro tempore. Pursuant to clause 8 of rule XX, further 
proceedings on this question will be postponed.
  The point of no quorum is considered withdrawn.

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