▶ 0:18:42Chair Grassley: Good morning, everyone. Today we have one denomination, six-- one nomination, six bills on the agenda for the character davis, who has been out -- patrick davis, who has been nominated to be assistant attorney general, on the agenda for the first time. He will be held over. The six bills on the agenda are ripe for consideration.
▶ 0:19:08Chair Grassley: Today's markup is about addressing the high cost of prescription drugs and abusive practices that keep prices high for too many american families. These bills are not new.in fact , we voice-voted them out of committee february 2023.
▶ 0:19:32Chair Grassley: But we are back here today since the leader of the senate refused to bring them up in the senate last year. So we are taking another shot at making sure consumers aren't being taken advantage of by anticompetitive practices which are then stopped cheaper generics from reaching the market in a timely fashion.
▶ 0:19:59Chair Grassley: It's time to make the system work better for people who need it most. The patients and consumers who cannot afford to keep paying skyhigh prices for their prescription drugs. The bills that we are discussing today are designed to directly tackle these issues. Among other things, we want to end pay for delayed ideals.
▶ 0:20:27Chair Grassley: Right now some brand name drug manufacturers pay generic companies to keep cheaper options off the market. That should have stopped a long time ago. We're at it again. He also want to fix abus--we also want to fix abusive patent practices and strengthen agency collaboration.
▶ 0:20:51Chair Grassley: Not only do we want to encourage agencies such as the uspto and the fda to coordinate better on patents, we want to prevent companies from gaming the system through product hopping and packet tickets. Further, we want to curb the use of sham citizen petitions.
▶ 0:21:19Chair Grassley: This will make it easier for generics to obtain approval, get on the market quicker, thus lowering costs for everyone. Finally, we want to commit the ftc to finish work that is started in studying the impact of pbm's on competition.
▶ 0:21:43Chair Grassley: Understanding the pbm industry and collecting data will shore of marketplace transparency - shore up marketplace transparency and help us address concerns about abusive pbm practices. These bills won't just level the playing field for smaller companies. They will help make prescription drugs more affordable for the people who need them.
▶ 0:22:10Chair Grassley: At the end of the day, this is all about people that we represent. For too long consumers have been at the mercy of drug companies that can keep prices high by blocking competition and abusing the system. The bills we are looking to take up today will be a good step and changing that.
▶ 0:22:38Chair Grassley: It will be a win for families, for taxpayers, and for anyone who believe that competition leads to better prices. I am looking forward to working with everyone on these bills. Now a procedural commentary not of this committee, but a procedural commentary about the united states senate and prescription drug bills.
▶ 0:23:06Chair Grassley: I've spoken about how these bills have been on this committee's agenda before and voted out and probably in a noncontroversial way, or almost consensus way. These bills have never been brought up on the senate floor. If they have, they didn't get to be law.
▶ 0:23:31Chair Grassley: Secondly, we have pharmacy benefit manager legislation, not out of this committee, except for the one I spoke about that is an ftc study, but of three other committees in the united states senate and in the last congress at least one bill out of the house committee.
▶ 0:23:51Chair Grassley: Now, these bills aren't exactly the same motive these three committees in the senate, but they try to accomplish the same thing of making pbm's operation in the pricing of our drugs more transparent. Hopefully transparency driving down the cost of prescription drugs.
▶ 0:24:17Chair Grassley: Now, they collectively have about 65 or 70 senators cosponsoring, and that goes back to years. Now, all three of these bills have not been introduced yet in this congress, but the cantwell-grassley bill out of congress has been reintroduced.
▶ 0:24:37Chair Grassley: I can't understand why when we hear from all of our constituents at our town meetings or in email or in the phone calls about people wanting us to take legislation up that will get prescription drug prices down, it doesn't seem to come up in the united states senate and everybody is concerned about the issue.
▶ 0:25:02Chair Grassley: I think there is part of the problem is that through the last four years and maybe it is even going considering these two years, the senate's only meeting about two and a half days a week. This week is an exception because we have got to take up the budget.
▶ 0:25:19Chair Grassley: But what's wrong with the senate meeting five days a week so we can get some of this legislation and be more than just a confirming body for members of the executive branch of government? I think we all ought to think about how much we hear about our constituents complaining about prescription drug and we have bills with two thirds of the senate being sponsors of solving that problem, we can't get this done.
▶ 0:25:49Chair Grassley: When I came to the united states senate, we used to start at 1:00 on monday and go to 4:00 on friday for the now w --now we start at 5:30 on monday, work tuesday, wednesday, and if this was a normal thursday, but I explained it's not because we are taking the budget up, but most thursdays the senate stops at 2:00 in the afternoon on thursday.
▶ 0:26:11Chair Grassley: There is enough work for senators to work seven days a week if they want to on an individual basis, but we cannot solve this country's problems if we don't get together more than two and half days a -- a week to get business done. So I hope somebody will take what I said it too hard, and if they do something get done and if they don't, we will continue working two and a half days a week. Senator durbin.
▶ 0:26:40Sen. Durbin: Thank you, senator grassley, and I hope you will take that issue up with republican leadership. Yesterday I sent you a letter signed by the senate judiciary democrats, all of them, requesting that you hold a hearing on the nomination of ed martin to serve as U.S. attorney for the district of columbia. As you know, the U.S. attorney for washington, D.C., is one of the most important and powerful prosecutors in america.
▶ 0:27:08Sen. Durbin: This committee does not typically hold hearings for U.S. attorney nominees, but Mr. martin's record is so controversial and so objectionable that I feel we must hear from him under oath. Before I go into my background for this, I want to preface my remarks. One of the first hearings you scheduled, bipartisan hearing, was on the issue of anti-semitism.
▶ 0:27:32Sen. Durbin: There were some members of your side of the aisle who said it was there feeling we didn't put enough emphasis on it and they wanted to start hearing on anti-semitism. We happily join in that effort, and I think we had one common voice condemning anti-semitism in all of its efforts underway around this country, sadly, at this moment f why does that have anything to do with Mr. martin as U.S. attorney for the washington, D.C.?
▶ 0:27:58Sen. Durbin: Prior to his appointment as interim U.S. attorney, Mr. martin made appalling attacks against federal prosecutors and associated himself with individuals who clearly present a threat to our nation. Mr. martin was a leader of the so-called stop the steal movement to illegally overturn the 2020 election. He was physically on the grounds of the U.S. capitol on january 6.
▶ 0:28:23Sen. Durbin: But he has repeatedly dismissed or downplay the violence perpetrated against 140 members of law enforcement in this capitol on that day. Those of us who are here on january 6 know the truth, the brutal attacks on these policemen and other law enforcement is unprecedented. Listen to how Mr. martin, who wants to be the U.S. attorney for the district of columbia, described january 6. He posted on social media, and I quote, "like mardi gras in D.C.
▶ 0:28:55Sen. Durbin: Today. Love, faith, and joy. Ignore fake news." equally alarming, he has called for "less judgment for somebody who had a cop" -- hit a cop" during the january 6 attack. This is ed martin, who wants to be the chief prosecutor for the district of columbia. This is an outrageous statement for anybody to make, but even more so for someone nominated to be the lead prosecutor for the department of justice in the capital city.
▶ 0:29:25Sen. Durbin: Mr. martin's attacks on law enforcement don't stop there. He called federal prosecutors in every office he now seeks to lead " terrorists." terrorists, he said, for pursuing stiff sentences against violent january 6 offenders. I want to talk about one specific relationship we need to know a lot more about. Mr.
▶ 0:29:48Sen. Durbin: Martin needs to answer for his extensive ties to timothy hale, a january 6 offender with a long and vile record as a nazi sympathizer. Mr. martin not only has portrayed him as a victim of an unjust conviction, Mr. martin has repeatedly praised Mr. hale-cusanelli's character, despite his well-known history of anti-semitism, misogyny, and racism.
▶ 0:30:19Sen. Durbin: Mr. hale-cusanelli once said "hitler's should have finished the job." he also claimed he would "kill all jews and eat them for breakfast, lunch, and dinner," and he wouldn't need to season them because the salt from their tears would make them flavorful enough.
▶ 0:30:42Sen. Durbin: Days after the january 6 attack he was recorded saying he wished for another civil war and he would give jewish people "24 hours to leave the country." this is Mr. hale-cusanelli. And this sentencing hearing, a judge appointed by president somerset "statements and actions like his make jewish people less safe and less confident they can participate as equal members of our society."
▶ 0:31:14Sen. Durbin: After all of that happened last year, Mr. martin, who wants to be the chief prosecutor for the united states department of justice in washington, Mr. martin presented Mr. hale-cusanelli with an award. Where was the award given? At the trump that at the trump t bedminster club in new jersey. At that club, Mr. martin said that cusanelli was "an extraordinary man, an extraordinary leader." since january 20, Mr.
▶ 0:31:42Sen. Durbin: Martin has served as interim district attorney for the district of columbia and since the beginning he has used that position. One of his first official acts of office as acting U.S. attorney was to shut down the section of the U.S. attorney's office handling january 6 cases and fire a number of assistant attorneys simply because they were assigned to prosecute january 6 defendants. Before Mr.
▶ 0:32:06Sen. Durbin: Martin's appointment, he represented three january 6 defendeds defe defendants as counsel. He later failed to withdraw his representation of two of these defendants before taking action as interim U.S. attorney benefiting his clients. We raised this question with the D.C. board. He has gone so far as to turn the U.S.
▶ 0:32:28Sen. Durbin: Attorney's office into the personal law firm for the president and his unelected copresident, elon musk, threatening to prosecute various government employees, members of congress, and press outlets in an attempt to chill lawful speech. In february Mr. martin tweeted to Mr. musk the following, "if people are discovered to have broken the law or even acted simply unethically, we will investigate them," Mr.
▶ 0:32:58Sen. Durbin: Martin said, "and we will chase them to the end of the earth to hold them accountable," an assurance he gave to elon musk. Mr. martin stay true to his words. He has intervened to assist doge in its efforts to break into the U.S. institute of peace. Finally, Mr. martin has attempted to hide his record from this committee and the american people for american people f at. He has failed to provide a number of required disclosure to the committee.
▶ 0:33:27Sen. Durbin: Nearly 1000 hours of podcasts are no longer available on online platforms such as spotify and apple podcasts, interfering with our ability to review his record. Mr. martin is a nominee whose problematic record requires additional scrutiny by this committee. Don't take it from me. Listen to 100 -- 100! -- former assistant U.S. attorneys from across the political spectrum who work in the office of the district of columbia.
▶ 0:33:55Sen. Durbin: They sent the committee a letter and noted that they personally had "served no political agenda, no local party, and no political figure we serve justice as we are expected to and as the generations before us did." acreage this committee to hold a public hearing, noting that Mr. martin has done things that "typified authoritarian and totalitarian regimes of the most monstrous sort." these former prosecutors added that Mr.
▶ 0:34:24Sen. Durbin: Martin's "partisanship raises serious questions about whether he will perform the duties of U.S. attorney without fear or favor, as required." Mr. chairman, we gather together on this side of the out to ask for Mr. martin to appear before the committee and to testify under oath.
▶ 0:34:42Sen. Durbin: This situation with hale-cusanelli, were such an outrageous man who said a terrible things that I have not recounted them all -- should be given an award by the man who wants to be the chief prosecutor for the district of columbia. We owe it to the american people not to sweep this under the rug and not to ignore it I ask you if you will give us this opportunity to have Mr. martin testifying under oath.
▶ 0:35:10Chair Grassley: Before answering your question, my answer is going to be based upon practice of this committee as I understand it, theseat --at least for the last 40 years. I don't want what I'm saying to be interpreted as disagreeing with anything you described about this individual.
▶ 0:35:39Chair Grassley: Ok -- about this individual, because my staff is vetting him, and what you have heard is relatively new to me. Let me say this, based on the practice we have had, and we have had controversial U.S. da's before this committee before, our practice is in the last 40 years never to have a hearing.
▶ 0:36:06Chair Grassley: At this point I'm going to take the position of not having a hearing, because we are going to follow the usual process of any questions that any members want to submit outside of having a public hearing in writing to these will make sure you get the answer to your questions, and that is the way we have done it on other controversial U.S. attorneys.
▶ 0:36:34Sen. Durbin: If I could respond.
▶ 0:36:36Chair Grassley: Please do.
▶ 0:36:37Sen. Durbin: I believe that your members on the republican side of the aisle will be as outraged and embarrassed by this background as any member on the democratic side of the aisle. I would like to use the next few days to appeal to you personally--them personally to ask for this hearing so it is a bipartisan effort. We joined the we joined t together on the question of anti-semitism and we can stand together on this as well.
▶ 0:37:03Sen. Durbin: If we have not reached an agreement to hold a hearing by the next meeting of this judiciary committee, I'm going to ask for an official vote of the members of the committee on that question.
▶ 0:37:13Chair Grassley: I'd appreciate that. If I could facilitate meetings on it, I will be glad to do that. But I think I want to stick with precedent because we have a lot of U.S. attorney hearings and since we haven't in the past, I don't want to change the precedent that has been around most of the time that I know about.
▶ 0:37:36Sen. Durbin: I have a statement on the patent bills before us, but I will hold until we have completed this conversation. >> Mr. chairman, can I had a brief comment on the matter the ranking member just raised? On the matter of epw, there is a matter on which ed martin is involved that leads epw as well as this committee, it is both.
▶ 0:38:00Sen. Durbin: I want to put this recent news article into the record the details the efforts both at epa and at the department of justice to engage what I consider to be wrongful and willful abuse of the criminal justice system. This is the matter I've mentioned before. Martin was told by his senior staff including the criminal division chief that he had no case to proceed with, so he fired the criminal division chief.
▶ 0:38:30Sen. Durbin: No other prosecutor in this large D.C. office would sign the pleading for the same reasons. There was no case there. He went ahead all by himself he when he had all by himself and got shot down by the magistrate judge, who said no, there is no case. Then they went ahead to try to find other offices to join in after they had been shot down.
▶ 0:38:49Sen. Durbin: In the meantime, epa and the department of justice were pursuing the same matter, same allegations of supposed fraud, in federal court related to the freeze. In that case they have been twice told by the federal court you have made no case, you have no evidence. Both martin, the U.S.
▶ 0:39:08Sen. Durbin: Attorney, and zeldin, epa administrator, have been making, I would contend, knowingly false accusations of fraud, contrary to what they were told by their own career staff, which rejected the allegations, contrary to what they were told by the magistrate judge, who rejected martin's application, and contrary to what they've been told twice by the federal court looking at the same matter.
▶ 0:39:36Sen. Durbin: That's pretty serious, because when you are engaging in derogatory and defamatory statements from an official position, you put the government at risk for liability and you are abusing your official powers. I will leave it at that, but I think that is kind of -- that is the concern that I have about this. I think he needs a good, vigorous public hearing.
▶ 0:39:58Chair Grassley: Without objection, your debts will be included. Senator schiff. --your article will be included. Senator schiff. Before you speak, could I urge everybody to keep your remarks relatively short so we can get on with the agenda? I want to take care of these prescription drug bills.
▶ 0:40:21Sen. Schiff: Thank you, Mr. chairman, I will keep my remark to bree. I want to thank ranking member durbin for his leadership on this and requesting the hearing. I placed a hold on Mr. martin for many of the reasons the ranking never articulated. There are others as well. As the ranking member eluded him this is a partial list of our concerns.
▶ 0:40:48Sen. Schiff: Some involve the fact that he has moved to dismiss cases against his own clients, a patent conflict of interest. But the list is long and I know it is extraordinary to request a hearing on a U.S. attorney nominee. I would urge the chairman instead of rejecting the question, as a judge would take the matter unr submission, to let us make a further case for why this merit s a hearing.
▶ 0:41:16Sen. Schiff: But on the particular issue that ranking member durbin raised, his embrace of this note and-- known and vocal anti-semite hale-cusanelli, I want to just broaden the aperture bit because I see the administration going after universities, using the pretext of anti-semitism to bludgeon universities, to threaten their livelihood with the threats to hundreds of millions of dollars if not more
▶ 0:41:46Sen. Schiff: In grant funding, in the name of combating and I semitism -- combating anti-semitism. I want to make the point, do not bludgeon universities in my name. I'm jewish. Do not bludgeon universities in my name. Do not do this pretending you are serious about combating anti-semitism. That's not what this is about. You want to come back anti-semitism? Don't embrace a U.S.
▶ 0:42:14Sen. Schiff: Attorney who wraps his arms around a known anti-semite like hale-cusanelli. Just don't do it. If ed martin was at a college university with hale-cusanelli, they would probably be both grabbed by masked ice agents and whisked out of the country. I'm not asking for that, either, but we should at least make sure we are not confirming a fellow traveler with a known bigot anti-semite like hale-cusanelli.
▶ 0:42:47Sen. Schiff: Look, it was a painful year for everyone in the jewish community watching what was happening and universities around the country. It's still painful. I have a lot of disagreement with how universities handle that many of these protests. But to ignore any due process for these universities, to grab students off the street wearing masks, that's not how we act in this country.
▶ 0:43:18Sen. Schiff: And to chill speech on campus, to attack academic freedom, to do so with no process whatsoever merely because the administration can, this is how we are going to kill these premier institutions and all of the profound research and economic benefits the country derives. So if you're going to do this, don't do it in my name, because this is not about anti-semitism.
▶ 0:43:48Sen. Schiff: And if we want to be serious about it, we cannot be confirming people that are wrapping your arms around bigots like hale-cusanelli. So I appreciate the chairman hearing this out and taking the matter under submission, and we will provide you, Mr. chairman, with the itemization of our concerns and hope that you will consider a hearing. And I yield back.
▶ 0:44:12Chair Grassley: Senator from connecticut.
▶ 0:44:16Sen. Blumenthal: Mr. chairman, thanks for allowing us to talk about this nominee, who is really almost unique in my experience. I have served as a united states attorney. I have worked with them about as a prosecutor and as a defense counsel over decades. My colleague senator schiff has opened the aperture.
▶ 0:44:41Sen. Blumenthal: I join in his remarks about the need to assess more objectively what is happening on universities and avoid tarring all of them with a broad brush at this administration seems to be doing and threatening them in the name of anti-semitism in ways that I think a bridge free speech and first amendment rights.
▶ 0:45:06Sen. Blumenthal: But I would like to close the aperture on ed martin because he is dangerous. He is dangerous to our justice system. I would like to put in the record an npr report of summer 12, 2024, about his participation in the awarded to Mr. hale-cusanelli. But that act and others, while serving as an interim U.S.
▶ 0:45:34Sen. Blumenthal: Attorney in the post that he would fill permanently I think disqualify him completely from this job. In the interest of brevity, I will stop there, Mr. chairman. But I urge you and plead with you to give us a chance to hear from him and others who may have observations about his record in the past because I think on this committee we have a very bipartisan commitment to our justice system and its integrity
▶ 0:46:06Sen. Blumenthal: That would be stained by improving this nominee and certainly would be diminished and undermined if we do so without a hearing. I urge the chairman, knowing of his fair and dispassionate approach to our justice system, to allow us to have a hearing on Mr. martin.
▶ 0:46:30Chair Grassley: Before I call on senator durbin for his closing -- or his opening statement, I don't take disagreement with what you are saying about whether we ought to have a hearing hear or not. But I take exception to what you have said about what is happening on our campuses, whether it is antisemitic or anything else that you are speaking about, not using your name connected with those things.
▶ 0:47:01Chair Grassley: When you have people go on campus and you have them break windows to get in and occupy a room on a college campus and all those sorts of things and you don't allow the campus police to get involved in arrest, it seems to me like we have a responsibility to make sure if we are going to have freedom of speech on campuses that we are to have an environment on those
▶ 0:47:32Chair Grassley: Campuses where you can actually have a dialogue with each other without having the violence that was connected with it. And I'm going to back our president stepping up to make sure that we have open campuses, police can make sure there is peace on campus, and that we are going to have open dialogue and move ahead with what universities are for.
▶ 0:47:58Chair Grassley: My definition of university is where disagreement ought to run rampant, but do it in a way that you have peaceful discussion of those issues. Senator durbin.
▶ 0:48:13Sen. Durbin: Thanks, chairman grassley. I think we will turn to s. 1097, the interagency patent coordination and improvement act of 2025. The bill was reported out of the committee by voice vote in each of the past two congresses. The bipartisan legislation is a good governance bill that improves information sharing between the fbi and the patent office for joint work on patent matters including pharmaceutical patents.
▶ 0:48:42Sen. Durbin: The bill would establish a task force to ensure the agencies share the information and have visibility into the work each may be engaged in. I ask that the remainder of my remarks be entered into the record.
▶ 0:48:55Chair Grassley: Ok, that will be so ordered. First we call up s. 527, prescription pricing for peoples act 2025. Bill requires the federal trade commission to examine the roles of pbm's and other intermediaries within the prescription drug supply chain and provide recommendations to approve competition -- improve
▶ 0:49:25Chair Grassley: Competition and transparency. The bill has 11 cosponsors and in a number of groups that support it. As I said before this bill unanimously passed out of congress last session. Are there any amendments? If there are no amendments, I think we can have a voice vote. All in favor say aye.
▶ 0:49:45Sen. Hirono: I'm sorry, Mr. chairman I should have been more alert. May I say a few words regarding this bill which I am a cosponsor of? I want to mention that I will be supporting the bills on our agenda, not necessarily the amendment, but I wanted to note that the multiple of these bills rely on the ftc to study problems or challenge anti-competitive practices, and one problem is there isn't a functional ftc right now because president trump fired the two
▶ 0:50:20Sen. Hirono: Democratic ftc commissioners. The legality of this firing is being challenged because the fireman goes directly against the 90-year-old supreme court precedent that was decided unanimously. But in the meantime, the patients suffer. The ftc's administrative case against the three largest pbm's alleging they artificially inflated the price of insulin, something that we all care about.
▶ 0:50:47Sen. Hirono: So the two republican fcc commissioners are recused from the case and the two democratic commissioners have been locked out of the building. So who can actually hear that administrative action against these pbm's? We have no idea. The situation is unprecedented.
▶ 0:51:05Sen. Hirono: And again, I'm happy to work with my colleagues on these bills because I do have some concerns about unintended consequences of these bills, but I want to point out this is yet another example of president trump sewing chaos -- sowing chaos where everyday americans will be the ones to suffer. Thank you, Mr. chairman.
▶ 0:51:26Chair Grassley: Ok, I would like to kind of make an explanation of the concern you brought up. Under cfr section 4.14, the ftc can operate and have a quorum with fewer than five commissioners, and the ftc's legal counsel can provide any necessary authorization under current law.
▶ 0:51:48Chair Grassley: Studies like this are something that ftc routinely does in the ordinary course of business, and they will continue to operate regardless of which commissioners are there. Requiring a final study for something that the ftc is already looking into is far from a heavy lift in the survey. Not the biggest concern right now. Those in favor of s. 527 say aye . Opposed to say no.
▶ 0:52:18Chair Grassley: The ayes have it, so the bill will be passed out. Next we will take up -- before I do that, I want to say that I just now realized that we were missing a member when I held over patrick davis's name. Now that I have a quorum, we are holding over patrick davis's name.
▶ 0:52:43Chair Grassley: 1040, to amend the federal trade commission act to prohibit product hopping for other purposes. Would anyone like to speak on the bill? Senator cornyn.
▶ 0:52:54Sen. Cornyn: Mr. chairman, thank you for letting me speak about s. 1040, and if you don't mind I will include comments about 1041, which is related to that, which we will also vote on for each of these bills addresses a problem that leads to higher drug prices for patients, and I appreciate senator blumenthal for working with me over many years now to try to get these bills across the finish line and to president trump's desk.
▶ 0:53:24Sen. Cornyn: One thing I have learned in the senate is persistence pays off. Sometimes you just have to grind it out over a long time in order to accomplish what you were trying to get done. On s. 1040, the drug competition enforcement act was part of the affordable prescriptions for patients act and was p assed out of the committee for several congresses in a row. This bill addresses a phenomenon called product hopping.
▶ 0:53:54Sen. Cornyn: This isa practice where a company will hop patients from one drug that it is close to losing exclusivity under its patent to a similar newer drug, or maybe one with a new label or one with a different dose requirement, in order to deliberately foreclose generic competition. I have heard from my colleagues on this committee that some of them still have questions about the bill.
▶ 0:54:22Sen. Cornyn: They want to make sure that the text is crafted to ensure there are no unintended consequences. That is a concern I also share. And there are no downstream impacts on innovation. I know my friend senator lee has filed an amendment reflecting some of his concerns, and I want to thank him and other colleagues for their engagement on this important issue.
▶ 0:54:45Sen. Cornyn: I share their concern about protecting innovation, and I promise to continue working to address any concerns that still linger about this bill as we moved to the floor. As we know, nothing moves across the floor without a lengthy procedural process if even a single senator objects. I will be happy to work with him and others.
▶ 0:55:11Sen. Cornyn: I look forward to continuing all of our efforts to address the problems of high drug prices for texans and all-americans.
▶ 0:55:20Sen. Blumenthal: Mr. chairman?
▶ 0:55:23Chair Grassley: Mr. -- welp senatol-- well senator coons, first.
▶ 0:55:32Sen. Coons I Share: The conviction that we need to expand access to cutting-edge legislation. Mr. chairman, I want to particularly commend you on your work on pharmacy benefit manager legislation and the role that pbm's play in the drug distribution process and the bill that improved sharing of information between pto and fda.
▶ 0:55:56Sen. Coons I Share: I think there are remaining concerns I will briefly mention about this bill that I look forward to working with senator blumenthal and corning in particular product hopping and whether it could sweep legitimately innovative products into the category of prohibited switches. I'm confident we can work together as the bill advances to address these concerns and make sure we don't compromise a strong, reliable patent system, which is the heart of our innovation ecosystem.
▶ 0:56:23Sen. Coons I Share: I think strong and effective patent protection incentivizes innovation and supercharges our place in the world, and I will continue to work with my colleagues on both these bills and others that strengthen patents.
▶ 0:56:35Chair Grassley: Senator from utah, and then the senator from connecticut.
▶ 0:56:40Sen. Lee: I want to thank mike friend and colleague senator cornyn for working with me on this issue. This is an issue that I hope we can address and deal with adequately before this gets to the floor.
▶ 0:56:56Sen. Lee: My amendment is pretty simple, it would just ensure that companies that have been taken to court based on the presumption of anti-competitive behavior can justify that behavior by providing evidence that the new product provides meaningful improvement in safety for effectiveness or provides a meaningful benefit to patient care relative to the listed drug before that happens.
▶ 0:57:21Sen. Lee: Is there a reasonable change to the bill that will only improve it and at the same time protect innovative improvements. We want to minimize the risk of accidentally taking in a larger universe than we need to in order to protect his interest -- those interest. I think that would help, but I look forward to working with senator cornyn on the issue is the bill advances to the floor. Without understanding, I will support it today.
▶ 0:57:50Sen. Lee: --with that understanding, I will support it today.
▶ 0:57:53Chair Grassley: Senator from connecticut.
▶ 0:57:55Sen. Blumenthal: I want to begin by thinking senator cornyn for his long-standing partnership on this bill through many ups and downs, and say that I share the chairman's very well-articulated in patients with the pace of -- impatience with the pace of reform in the patent area, particularly as it affects prescription drugs. The fact is drug prices are too high.
▶ 0:58:25Sen. Blumenthal: One of the reasons is big pharmaceutical companies, big pharma, are able to game the patent system, engaging in a patent dance that creates barriers to innovation and competition.
▶ 0:58:42Sen. Blumenthal: Generics and biosimilars play a critical role in making drugs more affordable, but pharmaceutical companies abuse and manipulate the patent system to block generics from coming to the market and providing more affordable and accessible means of treatment for the average american. The drug competition enforcement act would prohibit product hopping and it would also stop other kinds of abuses.
▶ 0:59:08Sen. Blumenthal: We are sensitive to the concerns raised by our colleague senator coons and senator lee, well-founded concerns in the abstract. And we will seek to accommodate them. But I must say that the basic provisions of this bill that protect competition and innovation are essential to making drugs more affordable to the everyday american who knows with great anger and frustration how difficult prescription drugs
▶ 0:59:42Sen. Blumenthal: Have become to afford. So I am hopeful that we can cross the finish line. I want to thank the chair for giving us this -- the chairman for giving us this vote and the opportunity to speak.
▶ 0:59:56Chair Grassley: An eminence? Hearing -- any amendments? Hearing on, those in favor say aye. Though supposed to say no. The ayes have it. Senator blackburn asked that she be recorded as nay on 1040.
▶ 1:00:17Chair Grassley: Next we will take up 1041, amending title 35 to address infringement of patents that claim biological products and for other products -- for other purposes. Would anyone like to speak on this bill?
▶ 1:00:31Sen. Cornyn: Very briefly on 1041, this bill is designed to address a situation where manufacturers actually file for multiple patents on the same drug in order to prevent any competition.
▶ 1:00:49Sen. Cornyn: In fact, one of the most infamous example of that is the case of one manufacturer who's filed over 100, and I believe it is closer to 130 different patents on the same drug in order to prevent it from ever going generic. This bill makes thoughtful reforms to the process by which biologic drugmakers and biosimilars competitors can voluntarily resolve patent litigation.
▶ 1:01:17Sen. Cornyn: It will increase the speed at which competitive drugs can come to market, increasing options for consumers and lowering prices. This bill passed the senate unanimously last year, and I look forward to moving it out of the senate with all due speed this year. Thank you, Mr. chairman.
▶ 1:01:33Chair Grassley: Are there any amendments? If not, on 1041, those in favor say aye. Opposed say no. The ayes have it, so it will be reported. Next, s. 1097, interagency patent coordination and impairment act of 2025. Would anyone like to speak on this bill? Are there any amendments? If not, those in favor of 1097 say aye.
▶ 1:02:05Chair Grassley: Though supposed to say no- - -those opposed say no. Ok. The ayes have it, 1097 is passed. We will next go to 1095, stop stalling act. Does anyone want to speak on this bill? >> yes, I would, Mr. chairman, since you and I did this deal together.
▶ 1:02:28Chair Grassley: Go ahead.
▶ 1:02:31Sen. Klobuchar: And the cosponsors as well. Generic have to be safe, but for too long the pharmaceutical companies have been abusing the petitioning process to advance their own commercial interests. They submit sham petitions that are either completely groundless or that are filed at the last minute before generic approval.
▶ 1:02:53Sen. Klobuchar: Sometimes they raise issues in multiple petitions, and all of this is done to stop competitors from getting on the market, making drugs less expensive and better for the rest of the public. Our bipartisan bill would provide a tailored solution to deter them from engaging in sham petitioning, and I thank you for your leadership on this.
▶ 1:03:14Chair Grassley: Does anyone have an amendment? Please proceed. >> thank you, Mr. chairman. I've got two amendments. First, my amendment sil 2544 would strike the presumption under the legislation saying that any series of conditions referred to the ftc by the
▶ 1:03:46Chair Grassley: Secretary of hhs are to be presumed by the federal district court to be sham conditions and therefore anticompetitive. We've got concerns with this provision of the bill because telling a federal district court that it must presume under these circumstances that the company has violated the law because a federal agency, one that I would add lacks enforcement authority in this area, has determined that the petitions filed by
▶ 1:04:18Chair Grassley: Citizens, as is their constitutional right, are themselves by virtue of their existence meant to impede the approval of an application for a new drug. Now, I know that companies do sometimes file sham petitions. Every year that this happens, to a degree, to use the government process to delay the approval of applications.
▶ 1:04:45Chair Grassley: I think we can all agree that that is not a good thing, and that we have to try to minimize that insofar as we can. But we must at the same time as we are trying to fix the problem be careful not to over correct in a way that would make matters worse, and to presume that companies are guilty of and I competitive behavior before they have their day in court -- guilty of anticompetitive behavior before they have their day in court.
▶ 1:05:14Chair Grassley: It ends up giving them a shallow, late, and blind opportunity for due process. As I understand it, the secretary of health and human services already has the authority to refer petitions that they believe to be sham petitions to the ftc for enforcement. And that process, plus the additional authorities that this bill grants the ftc, should be enough to stop there abuse.
▶ 1:05:40Chair Grassley: If I could speak to my second amendment, the second one, sil 25445, with simply -- would simply replace the word " revenue" with the term "net profits" for purposes of the cap on penalties. If the company's founder to abuse the process by filing sham petitions.
▶ 1:06:07Chair Grassley: The threat of losing all of the net profits earned from the sale of any drug by a company that is engaged in the filing of a sham petition should be, and I think genuinely is, sufficient deterrent against bad behavior. I think a case could be made for this legislation, this effort to push back on sham petitions, but I think we have to be careful not to over correct, and both of my amendments would help that.
▶ 1:06:36Chair Grassley: Senator klobuchar?
▶ 1:06:38Sen. Klobuchar: Thank you very much, Mr. chairman, enter very briefly respond, senator lee and I work well on so many things. I disagree with him on the summons. The second one --disagree with him on these amendment. The second one would have a major effect on the bill because the change would mean that drug companies in all circumstances would retain all the money earned while illegally boxing out competition that could be contributed to any expense.
▶ 1:07:06Sen. Klobuchar: Companies would retain earnings paid in taxes to finance debit lost depreciation and even the salaries and bonuses of those involved in the scheme. Here I am talking about offending companies for offending companies f if a branded drug company knows the maximum penalty that is limited to their net profits, they will be incentivized to pursue significant profits by engaging in anti-competitive conduct. That is why I oppose the second one.
▶ 1:07:34Sen. Klobuchar: On the first front, on that bill, our bill, the stop stalling act, kind of an amusing name as the day goes on, the bill allows the ftc to rely on findings by the secretary of hhs that a petition was filed "for the primary purpose of delaying the approval of generic or biosimilar drugs," unless the petitioner can prove by preponderance of the evidence that the petition was not a sham.
▶ 1:08:02Sen. Klobuchar: This amendment, senator lee's amendment, would eliminate the ftc's ability july on the hhs determination in court. We know hhs regularly makes these filings striking the presumption would significantly weaken the effectiveness of the bill and force the ftc to proof from the ground up many of the same fact that were already weighed and assessed by hhs. With all due respect, I encourage my colleagues to vote against the amendments.
▶ 1:08:33Sen. Klobuchar: I don't know if you are going to formerly call them up. We are always happy to work with you, senator lee, going forward.
▶ 1:08:39Chair Grassley: Senator lee.
▶ 1:08:41Sen. Lee: Thank you. I appreciate the thoughtful insight and the passion expressed by my friend and colleague senator klobuchar. Your points are born of a desire to solve the problem, I respect that.
▶ 1:08:57Sen. Lee: But let's talk about your response to both of those turning first to number 445, that becomes even more important, the fact that it goes into -- I don't think there's any company in america that would find that a deterrent to say we are going to take it out of your profits in order to do it as opposed to net revenues.
▶ 1:09:17Sen. Lee: But when you put it on the net revenue, you compound the problem that I'm trying to address through the other amendment, 544, because what you are dealing with here is a real opportunity for a strong gotcha moment.
▶ 1:09:37Sen. Lee: If the secretary of hhs makes a finding that this happened, and if that finding didn't adequately take these things into account come as there is in federal district court for opportunity for due process, for filings before any determination is made, we don't even have the substantive guidelines in place in order to make sure that there is due process at the agency level and agencies typically aren't equipped to be the
▶ 1:10:07Sen. Lee: Purveyor and protector of due process. You can have a finding of potentially arbitrary finding on the part of the hhs secretary which results in real gotcha moment of the companies standing to take a hit not just as to profits, but as to net revenue. These two things work in tandem to make sure that this doesn't create an unfair gotcha moment, which I think would be bad, would end up being counterproductive.
▶ 1:10:38Sen. Lee: I stand behind both of these and I would like a roll call vote on both.
▶ 1:10:40Chair Grassley: Ok. The clerk will call the roll on -- let's see, we have got to have two separate rollcall votes. >> [indiscernible]
▶ 1:10:55Sen. Lee: Yes, 5444, the one that deals with the authority within the agency -- within hhs to make the finding, thank you. >> Mr. graham?
▶ 1:11:15Chair Grassley: No by proxy. >> Mr. cornyn? >> no. >> Mr. lee? Mr. cruz?
▶ 1:11:25Chair Grassley: Aye by proxy. >> Mr. hawley?
▶ 1:11:31Chair Grassley: No by proxy. >> Mr. tillis?
▶ 1:11:35Chair Grassley: No by proxy. >> Mr. kennedy could chair
▶ 1:11:39Grassley: No by proxy. >> Ms. blackburn?
▶ 1:11:42Chair Grassley: No by proxy. >> Mr. --
▶ 1:11:46Chair Grassley: I'm sorry. He voted for himself. >>Mrs. moody? >> no. >> Mr. durbin?
▶ 1:11:55Sen. Durbin: No. >> Mr. whitehouse? >> no. >> Ms. klobuchar? >> no. >> Mr. coons?
▶ 1:12:06Sen. Durbin: No by proxy. >> Mr. blumenthal. >> no. >> Ms. hirono. >> no. >> Mr. booker.
▶ 1:12:18Sen. Durbin: No by proxy. >> Mr. padilla. >> no. >> Mr. welch. >> no. >> Mr. schiff. >> no. >> chairman grassley.
▶ 1:12:32Chair Grassley: No. >> thank you, ayes are 3, nays r 19.
▶ 1:12:41Chair Grassley: Ok, the amendment is lost. On the second amendment, rollcall vote?
▶ 1:12:47Sen. Lee: I would like a local vote on the second amendment, 5445, the one that says the cap on the penalty would be attached instead of saying revenue replaced with determinate net profits. >> Mr. graham.
▶ 1:13:04Chair Grassley: No by proxy. >> Mr. cornyn. >> no. >> Mr. lee.
▶ 1:13:12Sen. Lee: Aye. >> Mr. cruz.
▶ 1:13:15Chair Grassley: Aye by proxy. >> Mr. hawley.
▶ 1:13:21Chair Grassley: No by proxy. >> Mr. kennedy.
▶ 1:13:24Chair Grassley: No by proxy. >> Mrs. blackburn.
▶ 1:13:27Chair Grassley: No by proxy. >> Mrs. moody. >> no. >> Mr. durbin.
▶ 1:13:36Sen. Durbin: No. >> Mr. whitehouse. >> no. >> Mrs. klobuchar. >> no. >> Mr. coons.
▶ 1:13:45Sen. Durbin: No by proxy. >> Mr. blumenthal. >> no. >> Mrs. hirono. >> no. >> Mr. booker.
▶ 1:13:55Sen. Durbin: No by proxy. >> Mr. padilla. >> no. >> Mr. schiff. >> no. >> ayes are 3, nays are 19.
▶ 1:14:08Chair Grassley: The amendment lost. If there are no those in vaped -- no amendments those in favor vote aye. Those against vote no. Ayes have it. Senator lee will be recorded as no. And now the last bill, 1096, preserve access to affordable generics and biosimilars act.
▶ 1:14:39Chair Grassley: Anyone like to see -- to speak. The -- this is the payfinally a the -- this is the payfinally n the -- this is the payfinally t the bill.
▶ 1:15:01Chair Grassley: This er -- these are the cases that a brand named drug company uses their money to buy a generic manufacturing from offering patients a far more affordable version of the drug. In this arrangement both companies are in reach -- enriched. The brand-name companies says I do not want to have competition and they gave money to the generic and the only one that gets screwed is the consumer.
▶ 1:15:29Chair Grassley: I can go really strongly about this and we had court case is that have been helpful but there is a remaining problem with this. And under this bill a pay for agreement is presumed illegal. Unless they convinced the judge that this is procompetitive. Thank you. >> if you take alec west and the patent runs out, they will take the generic off the market until 2028 to keep the price up.
▶ 1:16:00Chair Grassley: Now, what more do you need to encourage innovation in the united states than 12 years of patent protection? And that runs out you ought to be able to get generic on the market.
▶ 1:16:10Chair Grassley: Anybody else wants to speak? Those in favor say aye. Those opposed say no. [laughter] the ayes have it and 1096 is reported. We are adjourned. [captioning performed by the national captioning institute, which is responsible for its caption content and accuracy. Visit ncicap.org]