• 2 days ago
The Senate Judiciary Committee holds a business meeting.

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Transcript
00:00who has been nominated to be Assistant Attorney General is on the agenda for the first time,
00:07so he will be held over. The six bills on the agenda are ripe for consideration.
00:15Today's markup is about addressing the high cost of prescription drugs and abusive practices that
00:23keep prices high for too many American families. These bills are not new. In fact, we voted them
00:34out of committee February 2023, but we're back here today since the leader of the Senate refused
00:43to bring them up in the Senate last year. So we're taking another shot at making sure consumers
00:52aren't being taken advantage of by anti-competitive practices, which then
00:59stop cheaper generics from reaching the market in a timely fashion. It's time to make the system
01:07work better for people who need it most, the patients and consumers who can't afford to keep
01:15paying sky-high prices for their prescription drugs. The bills that we're discussing today
01:23are designed to directly tackle these issues. Among other things, we want to end pay-for-delay
01:33deals. Right now, some brand-name drug manufacturers pay generic companies to keep cheaper
01:40options off the market. That should have stopped a long time ago. We're at it again.
01:49We also want to fix abusive patent practices and strengthen agency collaboration.
01:58Not only do we want to encourage agencies such as the USPTO and the FDA to coordinate better on
02:08patents, we want to prevent companies from gaming the system through product
02:15hopping and patent thickets. Further, we want to curb the use of sham
02:23citizen petitions. This will make it easier for generics to obtain approval,
02:30get on the market quicker, thus lowering costs for everyone. Finally, we want to commit the FTC
02:42to finish work that has started in studying the impact of PBMs on competition. Understanding the
02:51PBM industry and collecting data will shore up marketplace transparency and help us address
03:00concerns about abusive PBM practices. These bills won't just level the playing field for
03:09smaller companies. They'll help make prescription drugs more affordable for the people who need
03:16them. At the end of the day, this is all about people that we represent. For too long, consumers
03:27have been at the mercy of drug companies that can keep prices high by blocking competition
03:35and abusing the system. The bills that we're looking to take up today will be a good step
03:43at changing that. It will be a win for families, for taxpayers, and for anyone who believes
03:52that competition leads to better prices. I'm looking forward to working with everyone on
03:59these bills. Now, a procedural commentary, not of this committee, but a procedural commentary
04:09about the United States Senate and prescription drug bills. I've spoken about how these bills
04:16have been on this committee's agenda before and voted out in probably in a non-controversial way
04:25or almost a consensus way. These bills have never been brought up on the Senate floor. If they have,
04:33they didn't get to be law. Secondly, we have pharmacy benefit manager legislation,
04:42not out of this committee except for the one I spoke about that's an FDC study, but out of three
04:49other committees in the United States Senate and in the last Congress, at least one bill
04:55out of the House committee. Now, these bills aren't exactly the same out of these three
05:02committees in the Senate, but they try to accomplish the same thing of making PBM's
05:10operation in the pricing of our drugs more transparent, hopefully transparency driving down
05:19the cost of prescription drugs. Now, they collectively have about 65 or 70 senators
05:27co-sponsoring them, and now that goes back two years. Now, all three of these bills have not been
05:34introduced yet in this Congress, but the Cantwell-Grassley bill out of commerce has been
05:42reintroduced, and I can't understand why when we hear from all of our constituents at our town
05:49meetings or in the email or in the phone calls about people wanting us to take legislation up
05:57that will get prescription drug prices down, doesn't seem to come up in the United States
06:03Senate, and everybody is concerned about the issue. Now, I think there's part of a problem is
06:10that through the last four years, and maybe it's even going to consider in these two years,
06:17the Senate's only meeting about two and a half days a week. Now, this week is an exception
06:23because we got to take up the budget, but what's wrong with the Senate meeting five days a week
06:30so we can get some of this legislation and be more than just a confirming body for members
06:37of the executive branch of government? And I think we all ought to think about how much we hear about
06:43our constituents complaining about prescription drugs, and we have bills with two-thirds of the
06:49Senate being sponsors of solving that problem. We can't get this done. When I came to the United
06:57States Senate, we used to start at 10 on Monday and go to four on Friday. Now we start at 5 30
07:03on Monday, work Tuesday, Wednesday, and if this was a normal Thursday, but I explained it's not
07:10because we're taking the budget out, but most Thursdays, this Senate stops at two in the
07:16afternoon on Thursday, and there's enough work for senators to work seven days a week if they
07:23want to on an individual basis, but we can't solve this country's problems if we don't get together
07:30more than two and a half days a year a week to get business done. So I hope somebody will take
07:37what I said to heart, and if they do, something might get done, and if you don't, we'll continue
07:42working two and a half days a week. Senator Bergeron. Thank you, Senator Grassley, and I hope you'll take
07:50that issue up with the Republican leadership. Yesterday, I sent you a letter signed by the
07:57Senate Judiciary Democrats, all of them, requesting that you hold a hearing on the nomination of Ed
08:04Martin to serve as U.S. Attorney for the District of Columbia. As you know, the U.S. Attorney for
08:09Washington, D.C. is one of the most important and powerful prosecutors in America.
08:14This committee does not typically hold hearings for U.S. Attorney nominees, but Mr. Martin's record
08:21is so controversial and so objectionable that I feel we must hear from him under oath. Before I go
08:28into my background for this, I want to make a preface to my remarks. One of the first hearings
08:33you scheduled, a bipartisan hearing, was on the issue of anti-Semitism. There were some members
08:39of your side of the aisle who said it was their feeling we didn't put enough emphasis on it,
08:44and they wanted to start the hearing on anti-Semitism. We happily joined in that effort,
08:49and I think we had one common voice condemning anti-Semitism and all of its efforts that are
08:55underway around this country, sadly, at this moment. Why does that have anything to do with
09:00Mr. Martin as U.S. Attorney for Washington, D.C.? Prior to his appointment as interim U.S. Attorney,
09:07Mr. Martin made appalling attacks against federal prosecutors and associated himself
09:13with individuals who clearly present a threat to our nation. Mr. Martin was a leader of the
09:18so-called Stop the Steal movement to illegally overturn the 2020 election. He was physically
09:26on the grounds of the U.S. Capitol on January 6th, but he has repeatedly dismissed or downplayed the
09:32violence perpetrated against 140 members of law enforcement in this Capitol on that day.
09:39Those of us who were here on January 6th know the truth. The brutal attacks on these policemen
09:45and other law enforcement is unprecedented. But listen to how Mr. Martin, who wants to be
09:52the U.S. Attorney for the District of Columbia, described January 6th. He posted on social media,
09:58and I quote, like Mardi Gras in D.C. today, love, faith, and joy, ignore fake news, end of quote.
10:08Equally alarming, he has called for, quote, less judgment for somebody who hit a cop, close quote,
10:14during the January 6th attack. This is Ed Martin, who wants to be the chief prosecutor for the
10:20District of Columbia. This is an outrageous statement for anyone to make, but even more
10:25so for someone who's been nominated to be the lead prosecutor for the Department of Justice
10:30here in our capital city. Mr. Martin's attack on law enforcement don't stop there.
10:35He called federal prosecutors in every office he now seeks to lead, quote, terrorist,
10:42terrorist, he said, for pursuing stiff sentences against violent January 6th offenders.
10:48Now I want to talk about one specific relationship that I think we need to know a lot more about.
10:54Mr. Martin also needs to answer for his extensive ties to Timothy Hale Cusinelli,
11:00a January 6th offender with a long and vile record as a Nazi sympathizer. Mr. Martin not only has
11:08portrayed Mr. Hale Cusinelli as a victim of an unjust conviction, Mr. Martin has also repeatedly
11:14praised Mr. Hale Cusinelli's character. Despite Cusinelli's extensive, well-known history of
11:21anti-Semitism, misogyny, and racism, Mr. Hale Cusinelli once said, and I quote,
11:29Hitler should have finished the job, close quote. He also claimed he would, quote,
11:36kill all Jews and eat them for breakfast, lunch, and dinner, and he wouldn't need to season them
11:42because the salt from their tears would make it flavorful enough, end of quote. Days after the
11:48January 6th attack, he was recorded saying that he wished for another civil war and that he would
11:53give Jewish people, quote, 24 hours to leave the country. This is Mr. Hale Cusinelli. At his
12:01sentencing hearing, Judge Trevor McFadden, appointed by President Trump, said, and I quote,
12:08statements and actions like his, Cusinelli's, make Jewish people less safe and less confident
12:14they can participate as equal members of our society. After all of that happened last year,
12:22Mr. Martin, who wants to be the chief prosecutor for the United States Department of Justice in
12:27Washington, Mr. Martin presented Mr. Hale Cusinelli with an award. Where was the award given? At the
12:34Trump Bedminster Club in New Jersey. At that club, Mr. Martin said that Cusinelli was, quote,
12:43an extraordinary man, an extraordinary leader. Since January 20th, Mr. Martin has served as
12:50interim U.S. Attorney for the District of Columbia, and since the beginning days, he's
12:55abused that position. One of his first official acts of office as acting U.S. Attorney was to
13:02shut down the section of the U.S. Attorney's Office handling January 6th cases and fire a
13:07number of assistant attorneys simply because they were assigned to prosecute January 6th defendants.
13:14Before Mr. Martin's appointment, he represented three January 6th defendants as criminal defense
13:19counsel. He then later failed to withdraw his representation of two of these defendants before
13:26taking action as interim U.S. Attorney benefiting his clients. We raise this question with the D.C.
13:32Bar. He's gone so far as to turn the U.S. Attorney's Office into the personal law firm for the
13:38president and his unelected co-president, Elon Musk, threatening to prosecute various government
13:45employees, members of Congress, and press outlets in an attempt to chill their lawful speech.
13:50In February of this year, Mr. Martin tweeted to Mr. Musk the following,
13:56If people are discovered to have broken the law or even acted simply unethically, we will
14:03investigate them, Mr. Martin said, and we will chase them to the end of the earth to hold them
14:07accountable, an assurance he gave to Elon Musk. And Mr. Martin stayed true to his words. Among
14:13other actions, he's intervened to visit DOJ to assist DOJ in its efforts to break into the U.S.
14:19Institute of Peace. Finally, Mr. Martin has attempted to hide his records from this committee
14:25and American people. He has failed to provide a number of required disclosures to the committee.
14:32Nearly 1,000 hours of podcasts are no longer available online platforms, such as Spotify
14:39and Apple Podcasts, interfering with our ability to thoroughly examine his record. Mr. Martin is
14:44a nominee whose problematic record deserves additional scrutiny by this committee. Don't
14:50take it from me. Listen to 100 former U.S. Assistant U.S. Attorneys from across this
14:57political spectrum who worked in the office of the District of Columbia. They sent the committee a
15:02letter in that they noted that they personally had, quote, served no political agenda, no political
15:08party, and no political figure. We served justice as we were expected to and as the generations
15:13before us did. They urged this committee to hold a public hearing, noting that Mr. Martin has done
15:19things that, quote, typify authoritarian and indeed totalitarian regimes of the most monstrous
15:25sort. These former prosecutors added that Mr. Martin's, quote, evident partisanship raises
15:33serious questions about whether he'll perform the duties of U.S. Attorney without fear or favor,
15:38as required. Mr. Martin, Mr. Chairman, we gather together on this side of the aisle to ask for Mr.
15:45Martin to appear before the committee and to testify under oath. This situation with Hale
15:50Cusinelli, where such an outrageous man has said some terrible things, and I haven't recounted them
15:56all, should be given an award by the man who wants to be the Chief Prosecutor for the District of
16:03Columbia. We owe it to the American people not to sweep this under the rug and not to ignore it.
16:08I ask you if you will give us this opportunity of Mr. Martin testifying under oath.
16:17Before answering your question, my answer is going to be based upon practice of this committee,
16:28as I understand it, at least for the last 40 years. I don't want what I'm saying to be
16:36interpreted as disagreeing with anything you described about this individual.
16:44Yeah, okay. About this individual. Because my staff is vetting him, and what you've heard is
16:55relatively new to me. So let me say this. Based on the practice that we've had, and we've had
17:03controversial USDAs before this committee before, our practice is, at least in the last 40 years,
17:10never to have a hearing. So at this point, I'm going to take the position of not having
17:16a hearing, because we are going to follow the usual process, that any questions that any
17:23members want to submit outside of having a public hearing in writing to these, we'll make sure that
17:31you get the answers to your questions, and that's the way we've done it on other controversial
17:37U.S. attorneys. If I could respond. Please do.
17:46I believe that your members on the Republican side of the aisle will be as outraged and embarrassed
17:51by this background as any member on the Democratic side of the aisle. I would like to use the next
17:57few days to appeal to them personally to join us in asking for this hearing so that it's a
18:02bipartisan effort. We all joined together on the question of anti-Semitism. I think we can
18:07stand together on this as well. So if we have not reached an agreement to hold a hearing by the next
18:13meeting of this Judiciary Committee, I'm going to ask for an official vote of the members of
18:17the committee on that question. I appreciate that, and if I can facilitate meetings on it,
18:26I'll be glad to do that, but I think I want to stick with President because we could be having a
18:34lot of U.S. attorney hearings, and since we haven't in the past, I don't want to change the
18:39precedent that's been around most of the time that I know about. I have a statement on the patent
18:45bills before us, but I'll withhold that until we completed this conversation. Okay. Mr. Chairman,
18:49could I add a brief comment on the matter that the Chairman just, the Ranking Member just raised
18:54because I'm the Ranking Member in EPW, and there's a matter in which Ed Martin is involved
19:00that relates to EPW as well as to this committee. It's both, and I just want to put this recent
19:08news article into the record that details the efforts both at EPA and at the Department of
19:17Justice to engage in what I consider to be wrongful and willful abuse of the criminal
19:23justice system. This is the matter I've mentioned before where Martin was told by his senior staff,
19:29including the Criminal Division Chief, that he had no case to proceed with, so he fired the Criminal
19:35Division Chief. No other prosecutor in this large D.C. office would sign the pleading for the same
19:41reasons. There was no case there, so he went ahead all by himself. He went ahead all by himself and
19:47got shot down by the magistrate judge who said, no, there's no case. Then they went ahead to try
19:54to find other offices to join in after they'd been shot down. In the meantime, EPA and the
19:58Department of Justice were pursuing the same matter, same allegations of supposed fraud
20:05in federal court related to the freeze, and in that case, they've now been twice told by the
20:12federal court, you've made no case, you have no evidence, and both Martin, the U.S. attorney, and
20:19Zeldin, the EPA administrator, have been making, I would contend, knowingly false accusations of fraud
20:29contrary to what they were told by their own career staff, which rejected the allegations,
20:34contrary to what they were told by the magistrate judge, who rejected Martin's application, and
20:39contrary to what they've been told twice by the federal court looking at the same matter. That's
20:44pretty serious, because when you're engaging in derogatory and defamatory statements from an
20:48official position, you put the government at risk for liability and you are abusing your official
20:54powers. So I'll leave it at that, but I think that's kind of the concern that I have
21:01about this nominee and why I think he needs a good, vigorous public hearing.
21:08Without objection, you will be included. Thank you, Mr. Chairman.
21:15Before you speak, can I urge everybody to keep your remarks relatively short so we can get on
21:22with the agenda, because I want to take care of these prescription drug bills today. Yes, thank
21:28you, Mr. Chairman. I'll keep my remarks brief. I want to just thank Ranking Member Durbin for his
21:35leadership on this and for raising this issue and requesting a hearing. I placed a hold on Mr.
21:41Barton for many of the reasons that the Ranking Member has articulated. There are others as well,
21:47as Ranking Member Durbin alluded, this is just a partial list of our concerns. Some involve the
21:54fact that he has moved to dismiss cases against his own clients, a patent conflict of interest,
22:03but the list is long and I know it is extraordinary to request a hearing on a U.S.
22:08Attorney nominee. I would urge the Chairman, instead of rejecting the request to, as a judge,
22:14would take the matter under submission to let us make the further case for why this merits
22:20a hearing, but on the particular issue that Ranking Member Durbin raised, his embrace of
22:26this known and vocal anti-Semite, Hale Cucinelli. I want to just broaden the aperture a bit,
22:39because I see the administration going after universities,
22:45using the pretext of anti-Semitism to bludgeon universities, to threaten their livelihood with
22:51threats to hundreds of millions of dollars, if not more, in grant funding,
22:55in the name of combating anti-Semitism. I want to make the point, do not bludgeon the universities
23:04in my name. I'm Jewish. Do not bludgeon the universities in my name. Do not do this
23:10pretending you're serious about combating anti-Semitism. That is not what this is about.
23:15You want to combat anti-Semitism? Don't embrace a U.S. Attorney who wraps his arms around a known
23:22anti-Semite like Hale Cucinelli. Just don't do it. If Ed Martin was at a college university
23:31with Hale Cucinelli, they'd probably be both grabbed by masked ICE agents and whisked out
23:36of the country. I'm not asking for that either, but we should at least make sure that we're not
23:43confirming a fellow traveler with a known bigot anti-Semite like Hale Cucinelli.
23:53Look, it was a painful year, I think, for everyone in the Jewish community watching
23:57what was happening in universities around the country. It's still painful.
24:02I have a lot of disagreement with how universities handle many of these protests,
24:08but to ignore any due process for these universities, to grab students off the
24:16street wearing masks, that's not how we act in this country.
24:24And to chill speech on campus, to attack academic freedom, to do so with no process whatsoever,
24:31merely because the administration can, this is how we're going to kill these premier institutions
24:39and all of the profound research and the economic benefits the country derives.
24:46So if you're going to do this, don't do it in my name, because this is not about anti-Semitism.
24:54And if we want to be serious about it, we can't be confirming people
24:59that are wrapping their arms around bigots like Hale Cucinelli. So I appreciate the chairman
25:05hearing us out and taking the matter under submission, and we will provide you, Mr.
25:11Chairman, with the itemization of our concerns and hope that you will consider a hearing.
25:18And I yield back. Senator from Connecticut.
25:21Mr. Chairman, thanks for allowing us to talk about this nominee, who is really
25:31almost unique in my experience. And I've served as a United States attorney. I've worked with them
25:37both as a prosecutor and as a defense counsel over decades. And my colleague, Senator Schiff,
25:45has opened the aperture I join in his remarks about the need to assess more objectively what's
25:55happening on universities and avoid tarring all of them with a broad brush, as this administration
26:03seems to be doing, and threatening them in the name of anti-Semitism in ways that I think
26:10abridge free speech and First Amendment rights. But I'd like to close the aperture on Ed Martin
26:17because he is dangerous. He is dangerous to our justice system. I'd like to put in the record an
26:23NPR report of September 12, 2024, about his participation in the award to Mr. Hale Cucinelli.
26:32But that act and others, while serving as an interim U.S. attorney in the post that he would
26:44fill permanently, I think disqualify him completely from this job. In the interest of brevity, I will
26:52stop there, Mr. Chairman. But I urge you and plead with you to give us a chance to hear from him and
26:59others who may have observations about his record in the past, because I think on this committee we
27:06have a very bipartisan tradition of a commitment to our justice system and its integrity that would
27:13be stained by approving this nominee and certainly would be diminished and undermined if we do so
27:24without a hearing. So I urge the chairman, knowing of his fair and dispassionate approach to
27:32our justice system, to allow us to have a hearing on Mr. Martin. Before I call on Senator Durbin for
27:41his closing or his opening statement, I don't take disagreement with what you're saying about
27:48whether we ought to have a hearing here or not. But I do take exception to what you've said about
27:55what's happening on our campuses, whether it's anti-Semitic or anything else that you're
28:01speaking about, not using your name connected with those things, that when you have people go on
28:11campus and you have them break windows to get in and occupy a room on a college campus and all
28:20those sorts of things, and you don't allow the campus police to get involved and arrest, it seems
28:28to me like we have a responsibility to make sure if we're going to have freedom of speech on campuses
28:35that we ought to have an environment on those campuses where you can actually have a dialogue
28:42with each other without having the violence that was connected with it. And I'm going to back our
28:47president stepping up to make sure that we have open campuses, police can make sure that there's
28:54peace on campus, and that we're going to have open dialogue and move ahead with what universities
29:02are for. And my definition of a university is where disagreement ought to run rampant, but do
29:13it in a way that you have a peaceful discussion of those issues. Senator Durbin. Thanks, Chairman
29:22Grassley. I think we're going to turn to S1097, the Interagency Patent Coordination Improvement
29:27Act of 2025, which I introduced with Senator Tillis and is co-sponsored by yourself and Senators
29:32Coons and Welch. The bill was reported out of the committee by voice vote in each of the past two
29:37congresses. The bipartisan legislation simply is a good governance bill that improves information
29:42sharing between the FDA and the Patent Office for joint work on patent matters, including
29:47pharmaceutical patents. The bill would establish a task force to ensure the agencies share the
29:52information and have visibility into the work each may be engaged in and the specific data
29:57they may be privy to, and I ask the remainder of my remarks be entered in the record. Okay,
30:04that will be so ordered. First, we call up S527, Prescription Pricing for People's Act 2025.
30:15The bill requires the Federal Trade Commission to examine the roles of PDMs and other intermediaries
30:24within the prescription drug supply chain and provide recommendations to improve competition
30:30and transparency. The bill has 11 co-sponsors and a number of groups that support it. As I said
30:37before, this bill unanimously passed out of Congress last session. Are there any amendments?
30:45If there are no amendments, I think we can have a voice vote. All in favor, say aye.
30:52Sorry. I'm sorry, Mr. Chairman. I should have been more alert. May I say a few words regarding
30:58this bill, which I am also a co-sponsor of? I just wanted to mention that I will be supporting
31:04the bills on our agenda, not necessarily the amendments, but I wanted to note that the
31:09multiple of these bills rely on the FTC to study problems or challenge anti-competitive practices,
31:16and one problem is there isn't a functional FTC right now because President Trump fired
31:24the two Democratic FTC commissioners, and the legality of this firing is being challenged
31:31because the firing goes directly against a 90-year-old Supreme Court president that was
31:36decided unanimously. But in the meantime, it is the patients who will suffer. Take, for example,
31:42the FTC's administrative case against the three largest PBMs alleging they artificially
31:50inflated the price of insulin, something that we all care about. So the two Republican FTC
31:56commissioners are recused from the case, and the two Democratic commissioners have been locked out
32:02of the building. So who can actually hear that administrative action against these PBMs?
32:08We have no idea. This situation is unprecedented. And again, I am happy to work with my colleagues
32:15on these bills because I do have some concerns about unintended consequences of these bills,
32:20but I just want to point out this is yet another example of President Trump sowing chaos and
32:27where everyday Americans will be the ones to suffer. Thank you, Mr. Chairman.
32:32I'd like to kind of make an explanation of the concern you brought up. Under CFR section 4.14,
32:43the FTC can operate and have a quorum with fewer than five commissioners,
32:48and the FTC's legal counsel can provide any necessary authorization under current law.
32:54Studies like this are something FTC routinely does in the ordinary course of business,
33:01and they'll continue to operate regardless of which commissioners are there. Requiring a final
33:07study for something that the FTC is already looking into is far from a heavy lift, and it's
33:14certainly not the biggest concerns right now. Those in favor of S.527 say aye. Opposed say no.
33:26The ayes have it. So the bill will be passed out. Next we'll take up, before I do that, I want to
33:34say that I just now realized that we were missing a member when I held over Patrick Davis's name.
33:43So now that we have a quorum, I'm going to say we're holding over Patrick Davis's name.
33:501040, to amend the Federal Trade Commission Act to prohibit product hopping for other purposes.
33:58Would anyone like to speak on the bill? Senator Cornyn. Mr. Chairman, thank you for letting me
34:03speak about S.1040, and if you don't mind, I'm going to also include comments on 1041,
34:09which is related to that, which we will also vote on. Each of these bills addresses a problem that
34:16leads to higher drug prices for patients, and I appreciate Senator Blumenthal for working with me
34:22over many years now to try to get these bills across the finish line and to President Trump's
34:29desk. One thing I've learned in the Senate is persistence pays off. Sometimes you just have to
34:36grind it out over a long period of time in order to accomplish what you're trying to get done.
34:43On S.1040, the Drug Competition Enforcement Act was previously part of the Affordable
34:48Prescriptions for Patients Act and is passed out of the committee for several Congresses in a row.
34:54This bill, as you noted earlier, addresses a phenomenon called product hopping.
35:01This is a practice where a company will hop patients from one drug that is close to losing
35:08exclusivity under its patent to a similar newer drug, or maybe even one with a new label,
35:15or maybe one with a different dose requirement, in order to deliberately foreclose generic
35:21competition. I've heard from my colleagues on this committee that some of them still have questions
35:27about the bill. They want to make sure the text is crafted to ensure that there are no unintended
35:32consequences. That's a concern that I also share, and that there are no downstream impacts on
35:40innovation. I know my friend Senator Lee has filed an amendment reflecting some of his concerns,
35:47and I want to thank him and other colleagues for their engagement on this important issue.
35:52I share their concern about protecting innovation, and I promise to continue working to address any
35:59concerns that still linger about this bill as we move to the floor. As we know, nothing moves
36:04across the floor without a lengthy procedural process if even a single senator objects, and so
36:13I will be happy to work with him and others. I look forward to continuing all of our efforts
36:20to address the problems of high drug prices for Texans and all Americans.
36:28Senator Coons first. Thank you, Mr. Chairman, and just broadly, I share
36:35my colleague's conviction we have to do more to ensure that our constituents have access to and
36:40can afford cutting-edge medication. We are showing again today that we can work broadly on bipartisan
36:46legislation. Mr. Chairman, I want to particularly commend you for your work on pharmacy benefit
36:51manager legislation and the role that PBMs play in the drug distribution process and the bill that
36:58improves sharing of information between PTO and FDA. I do think there are some remaining concerns
37:04that I'll just briefly mention about this bill that I look forward to working with Senator
37:09Blumenthal and Cornyn, in particular product hopping and whether it could sweep legitimately
37:15innovative products into the category of prohibited switches. I'm confident we can
37:20work together as this bill advances to address these concerns and ensure we don't compromise
37:24a strong reliable patent system, which is the heart of our innovation ecosystem. I do think
37:30strong and effective patent protection incentivizes innovation and supercharges our place in the world
37:37and I will continue to work with my colleagues on both these bills and others that strengthen
37:42patents. Thank you. Senator from Utah and then the Senator for Connecticut. Yeah, I'll be brief.
37:48I just want to thank my friend and colleague Senator Cornyn for working with me on this issue.
37:54This is an issue that I hope we can address and deal with adequately before this gets to the
38:00floor. My amendment is pretty simple. It would just ensure that companies that have been taken
38:07to court based on a presumption of anti-competitive behavior can justify that behavior by providing
38:13evidence that the new product provides quote a meaningful improvement in safety or effectiveness
38:19or provides a meaningful benefit to patient care relative to the listed drug before that happens.
38:28This is a reasonable change to the bill that I think will only improve it and at the same time
38:36protect innovative improvements. We want to minimize the risk of accidentally taking in a
38:42larger universe than we need to in order to protect those interests. I think that would help but
38:48look forward to working with Senator Cornyn on this issue as the bill advances to the floor
38:53and with that understanding I'll support it today. Senator from Connecticut. Thank you. Thank you, Mr.
39:00Chairman. I want to begin by thanking Senator Cornyn for his long-standing partnership on this
39:08bill through many ups and downs and say that I share the chairman's very well-articulated impatience
39:19with the pace of reform in the patent area particularly as it affects prescription drugs.
39:29The fact is drug prices are too high. One of the reasons is that big pharmaceutical companies,
39:35big pharma, are able to game the patent system engaging in a patent dance that creates barriers to
39:44innovation and competition. Generics and biosimilars play a critical role in making
39:50drugs more affordable but pharmaceutical companies abuse and manipulate the patent system
39:57to block generics from coming to the market and providing more affordable and accessible
40:02means of treatment for the average American. The Drug Competition Enforcement Act would
40:09prohibit product topping. It would also stop other kinds of abuses. We are sensitive to the
40:15concerns that have been raised by our colleagues Senator Coons and Senator Lee. Well-founded
40:23concerns in the abstract and we will seek to accommodate them but I must say that the basic
40:31provisions of this bill that protect competition and innovation are essential to making drugs more
40:39affordable to the everyday American who knows with great anger and frustration how difficult
40:48prescription drugs have become to afford. So I am hopeful that we can cross the finish line.
40:56I want to thank the chairman for giving us this vote and opportunity to speak today. Thank you.
41:02Any amendments? A hearing none. Those in favor say aye. Aye. Those opposed say no.
41:10The ayes have it. 1040 will be reported and Senator Blackburn has asked that she be recorded
41:17as nay on S1040. Next we'll take up 1041 amending title 35 to address infringement of patents that
41:28claim biological products and for other products or other purposes. Would anyone like to speak on
41:36this bill? Mr. Chairman. Proceed. Very briefly Mr. Chairman on S1041. This bill is designed to
41:45address a situation where manufacturers actually file for multiple patents on the same drug in
41:52order to prevent any competition. In fact one of the most infamous examples of that is the case of
42:01one manufacturer who's filed over a hundred and I believe it's closer to 130 different
42:07patents on the same drug in order to prevent it from ever going generic. This bill makes
42:14thoughtful reforms to the process by which biologic drug makers and biosimilar competitors
42:19can voluntarily resolve any patent litigation. It'll increase the speed at which competitive
42:26drugs can come to market increasing options for consumers and lowering prices. This bill passed
42:31the Senate unanimously last year and I look forward to moving it out of the Senate with all
42:38due speed this year. Thank you Mr. Chairman. Are there any amendments? If not on 1041 those in
42:46favor say aye. Opposed say no. The ayes have it so it'll be reported. Next S1097 Interagency
42:55Patent Coordination and Improvement Act of 2025. Would anyone like to speak on this bill?
43:02Are there any amendments? If not those in favor of 1097 say aye. Those opposed say no.
43:14No. The ayes have it and so 1097 is passed. Next go to 1095 Stop Stalling Act. Does anyone want
43:28to speak on this bill? Yes I would Mr. Chairman since you and I do this bill together. Oh yeah
43:34please go ahead. Okay very good and I thank the co-sponsors as well. I think we all know that
43:40generic biosimilars have to be safe but for too long the pharmaceutical companies have been
43:46abusing the petitioning process to advance their own commercial interests. They submit these sham
43:51petitions that are either completely groundless or that are filed at the last minute before generic
43:58approval. Sometimes they raise the issues in multiple petitions and all of this is done
44:04to stop competitors from getting on the market making drugs less expensive and better for the
44:12rest of the public. So our bipartisan bill would provide a tailored solution to deter them from
44:17engaging in sham petitioning and I thank you for your leadership on this. Does anyone have an
44:23amendment? Yeah. Please proceed. Thank you Mr. Chairman. I've got two amendments. First my
44:39amendment SIL 25444 would simply strike the presumption under the legislation saying that
44:46any series of petitions referred to the FTC by the secretary of HHS are to be presumed by a
44:55federal district court to be sham petitions and therefore anti-competitive. I've got concerns
45:00with with this provision of bill because we're telling a federal district court that it must
45:06presume under these circumstances that the company has violated the law because a federal agency
45:14one that I would add lacks enforcement authority in this area has determined that the petitions
45:22filed by citizens as is their constitutional right are themselves by virtue of their existence
45:32meant to impede the approval of an application for a new drug. Now I know that companies do
45:39sometimes file sham petitions and every year that this happens to a degree to use the government
45:47process to delay the approval of drug applications and I think we can all agree that that's
45:53yeah that's that's that's not a good thing and that we have to try to minimize that insofar as
45:59we can but we must at the same time as we're trying to fix the problem be careful not to
46:04over correct in a way that would make matters worse and and require of course to to presume
46:11that companies are in fact guilty of anti-competitive behavior before they have their
46:16day in court and so it ends up with giving them a shallow late and blunted opportunity
46:26for due process so as I understand it the secretary of health and human services already has the
46:32authority to refer petitions that they believe to be sham petitions to the FTC for enforcement
46:40and that process plus the additional authorities that this bill grants the FTC should be enough
46:46to stop their abuse and then if I can if I can speak to the to my second amendment the second
46:52one which is SIL 25445 would simply replace the word revenue with the term net profits
47:01for purposes of the cap on civil penalties awarded under the legislation if a company
47:07is found to have abused the petition process by filing sham petitions the threat of losing all
47:13of the net profits earned from the sale of any drug by a company that's engaged in the filing
47:20of a sham petition should be I think genuinely is a sufficient deterrent against bad behavior
47:30so again I you know I think a case can be made for this legislation this effort to push back on
47:37sham petitions but I think we also have to be careful not to over correct and both of my amendments
47:42would help that. Senator Klobuchar. Thank you very much Mr. Chairman and just to very briefly
47:48respond Senator Lee and I work together so well on so many things and I disagree with him on these
47:53amendments the second one he brought up would really have a major effect on this bill because
48:01the change would mean that drug companies in all circumstances would retain all the money earned
48:07while illegally boxing out competition that can be attributed to any expense companies would retain
48:14earnings paid in taxes to finance debit loss to depreciation and even the salaries and bonuses of
48:21those involved in a scheme and here I'm talking about offending companies if a branded drug company
48:28knows the maximum penalty that it's limited to their net profits they'll be incentivized to
48:33preserve their significant profits by engaging in anti-competitive conduct so that's why I oppose
48:39the second one on the first front on that bill so our bill the stop stalling act kind of an amusing
48:47name as the day goes on the bill allows the FTC to rely on findings by the secretary of HHS that a
48:55petition was filed quote for the primary purpose of delaying the approval of generic or biosimilar
49:01drugs end quote unless the petitioner can prove by a preponderance of the evidence that the petition
49:07was not a sham this amendment Senator Lee's amendment would eliminate the FTC's ability to rely
49:13on the HHS determination in court and we know that HHS regularly makes these filings
49:21striking the presumption would significantly weaken the effectiveness of the bill and force
49:26the FTC to prove from the ground up many of the same facts that were already weighed and assessed
49:32by HHS so with due all due respect I encourage my colleagues to vote against the with the amendments
49:38I don't know if you're going to formally call them up and of course we're always happy to work with
49:42you Senator Lee going forward Senator Lee thank you yeah I appreciate the thoughtful insight and
49:49the passion expressed by my friend and colleague Senator Klobuchar I understand the concern and
49:56your your points are born of of a desire to solve the problem I respect that let's but let's talk
50:03about your response to both of those turning first to the number 445 that becomes even more
50:11important the fact that goes into it I don't think there's any company in America that
50:16wouldn't find that a deterrent to say that we're going to take it out of
50:19your profits in order to do it as opposed to net revenues but the when you put it on their net
50:26revenue you compound the problem that I'm trying to address through the other amendment 544
50:35because what you're dealing with here here is a is a real opportunity for a strong gotcha moment
50:43if the secretary of HHS makes a finding that this happened and if that finding
50:50didn't adequately take these things into account there weren't as there is in a federal district
50:55court a full opportunity for due process for filings before any determination is made
51:04we don't even have the substantive guidelines in place in order to make sure that there is due
51:09process at the agency level and agencies typically aren't equipped to be the purveyor and protector
51:15of due process so you can have a finding of potentially arbitrary finding on the part of
51:21the HHS secretary which then results in a real gotcha moment of the company standing to to
51:28to take a hit not just as to profits but as to net revenue so these these two things
51:35work in tandem to make sure that this doesn't create an unfair gotcha moment which I think
51:39would be bad I think it would end up being counterproductive so I stand behind both of
51:45these and I'd like a roll call vote on both okay the clerk will call the roll
51:52on uh let's see we've got to have two separate roll call votes so uh on the first
52:01yes uh uh uh five four four four uh which is um the the one that deals uh with the authority
52:10within the agency um within HHS to make the finding thank you
52:16uh no by proxy
52:26uh I by proxy
52:30no by proxy
52:38uh no by proxy
52:42no by proxy
52:46Mrs. Blackburn? No by proxy. Mr. Schmidt? I'm sorry he voted for himself.
52:57Mrs. Moody? No. Mr. Durbin? No. Mr. Whitehouse? No. Mrs. Klobuchar? No. Mr. Coons?
53:08No. No by proxy. Mr. Coons? No by proxy. Mr. Blumenthal? No. Mr. Ronald? No. Mr. Booker? No by proxy. Mr. Padilla? No. Mr. Welch? No. Mr. Schiff? No. Chairman Grassley? No.
53:38Thank you on this vote the ayes are three the nays are 19. Okay the amendment is lost
53:48those that oh the now on the second amendment you want a roll call vote? Yes I'd like a roll call
53:53vote on the second amendment the second one uh which is five four four five uh is the one
54:00that says that the cap on the penalty will be attached uh instead of saying revenue replaced
54:06with the term net profits. Mr. Graham? No by proxy. Mr. Cornyn? No. Mr. Lee? Aye. Mr. Cruz? Aye by proxy. Mr. Hawley?
54:24No by proxy. Mr. Tillis? No by proxy. Mr. Kennedy? No by proxy. Mrs. Blackburn? No by proxy.
54:33Mr. Smith? Aye. Mrs. Britt? No. Mrs. Moody? No. Mr. Goldman? No. Mr. Whitehouse? No.
54:44Ms. Klobuchar? No. Mr. Coons? No by proxy. Mr. Blumenthal? No. Mr. Ronald? No. Mr. Booker? No by proxy.
54:57Mr. Padilla? No. Mr. Welch? No. Mr. Schiff? No.
55:05Chairman Grassley? No. On this vote the ayes are three the nays are 19. Okay amendment lost
55:13those in favor of if there's no further amendments those in favor vote aye.
55:19Aye. Those opposed vote no. The ayes have it so 1095 is reported. Our last bill is
55:32Senator Lee will be recorded as no. Now the last bill 1096 preserve access to affordable generics
55:41and biosimilar acts would anyone like to speak on the bill? Senator Klobuchar? Yes I would
55:49and this is 1096 correct Mr. Chairman right? Yes. This is our pay for delay bill that we've been
55:57but delayed on for I don't know 10 years and this is actually finally an opportunity to pass this
56:04bill. What happens in these cases are that a brand name drug company uses their own money to
56:14buy off a generic drug manufacturer from offering patients a far more affordable generic version of
56:20the drug. In this arrangement sadly both companies are enriched the brand name company says hey I
56:28don't want to have any competition that gave money to the generic and the only one that gets screwed
56:33in the whole thing is the consumer. I feel really strongly about this we've had some court cases
56:39that have been helpful but there's still a remaining problem with this and under this bill
56:44a pay for delay agreement is presumed illegal unless the drug companies can convince a judge
56:50that the agreement is pro-competitive. Thank you. If you take Eloquist and Patent Runout
56:58you're going to pay they're going to keep the generic off the market until 2028. Keep the price
57:04up. Now does that what more do you need to encourage innovation in the United States
57:10than 12 years of patent protection? When that runs out you ought to be able to get to generic
57:16on the market. Anybody else want to speak? Those in favor say aye. Those opposed say no.
57:27The ayes have it and 1095 or 1096 is reported. We adjourn. Thanks everyone.

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