May 8, 2019 - Issue: Vol. 165, No. 76 — Daily Edition116th Congress (2019 - 2020) - 1st Session
All in House sectionPrev30 of 101Next
PURPLE BOOK CONTINUITY ACT; Congressional Record Vol. 165, No. 76
(House of Representatives - May 08, 2019)
Text available as:
Formatting necessary for an accurate reading of this text may be shown by tags (e.g., <DELETED> or <BOLD>) or may be missing from this TXT display. For complete and accurate display of this text, see the PDF.
[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. ____________________
All in House sectionPrev30 of 101Next