Further Extension of Continuing Appropriations Act, 2021

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.

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.

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. Speaker, I yield back the balance of my time.

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.

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.

Madam Speaker, on May 8, 2019, I was present and voted for two bills on the floor of the U.S. House of Representatives. I voted in favor of H.R. 1520, the Purple Book Continuity Act. However, my vote did not register on Roll Call 188. I voted to advance the legislation out of the Energy and Commerce Committee and supported its passage on the House floor.

Madam Speaker, on May 8, 2019, I was unable to be present to cast my vote on the Orange Book Transparency Act (H.R. 1503) and the Purple Book Transparency Act (H.R. 1520). Had I been present for roll calls No. 187 and 188, I would have voted AYE on both.

Mr. Speaker, I demand a recorded vote.