Biosecure Act

Floor Speech

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Mr. McGOVERN. Mr. Speaker, I rise in opposition.

Mr. Speaker, I deeply regret having to rise in opposition to this bill, but I feel that I need to, and I want to be clear as to why.

I think this bill as it is currently written, quite frankly, is not ready for prime time, and I am urging my colleagues, particularly those who care about effectively taking on China to vote ``no.''

Mr. Speaker, for the record, I am not new to this issue. In fact, I welcome the fact that we are finally here on the House floor talking about not only the abysmal human rights violations committed by the People's Republic of China but their unsavory and unscrupulous business practices that could threaten patient privacy and even our national security.

Frankly, it is about damn time.

I have been sounding the alarm for years now asking Democrats and Republicans to hold China accountable.

I have worked with Presidents of both parties on this issue, including Joe Biden and Donald Trump.

Along with our colleagues, Representative Chris Smith and Senator Marco Rubio, I wrote, and President Biden signed into law the bipartisan Uyghur Forced Labor Prevention Act to hold the PRC accountable for their genocide in Xinjiang and to prevent the import of goods made with forced labor into the United States.

Together, Chairman McCaul and I wrote the Resolve Tibet Act to hold the PRC accountable for their misinformation on Tibet, which was also just signed into law by President Biden a few months ago.

I passed into law the bipartisan Reciprocal Access to Tibet Act to deny PRC officials entry into the United States if they are responsible for the oppression of the people of Tibet. In 2019, I also authored legislation to prevent the export of crowd control equipment that was being used to go after peaceful protestors in Hong Kong, and President Trump signed that into law.

I am one of the few Members of Congress who was actually sanctioned by China. I am banned from going to China by the PRC. I can't meet with any Chinese Government officials because of my vocal advocacy for human rights and human dignity in that country. They clearly do not like me, but I wear their sanctions as a badge of honor.

All of this is to say that my record on this issue takes a back seat to nobody. That is why I deeply regret that we are bringing this particular bill to the floor. This is a lost opportunity to do something meaningful about an important and serious issue, an issue that frankly deserves a lot more thought and attention than this.

First of all, this bill lists out specific companies that it claims are exploiting the U.S. biopharmaceutical industry on behalf of the Chinese Government.

To be totally frank, some of them might be, but to be also totally frank, some of them might not be, and I can't get a clear answer from anyone on how the Select Committee came up with these names.

What was the process?

Were these companies brought in for questioning?

Again, no solid answers to why these companies and not others.

If we are going to name companies, then there ought to be a clear, transparent process that is implemented the same for all companies.

I am even told this by our regulatory agencies who, by the way, do not like the idea of naming companies by name in legislation because they think it gives the heads-up to bad companies who will try to evade this legislation as written by changing their name and reincorporating as something else in the Cayman Islands.

So I think we need to give some thought as to whether this is the best way to hold these companies to account.

The most ironic thing about this approach is this is how they do things in China: The PRC politicians decide they don't like you, so they blackball you.

Guess what, Mr. Speaker? That is not how we do things in the United States of America.

We ought to have due process of law here. We ought to have a transparent, inclusive process that involves all the relevant agencies that applies to all companies. We have an intelligence community, we have law enforcement agencies, we have an interagency entity list, and we have a Department of Defense 1260H list to determine what companies are engaged in bad behavior on behalf of the PRC.

Some of the companies listed in this bill are not on any lists at all, so it is up to us to guess why they are on here.

Now, I have no idea who wrote this text or why these companies and not others, but this is not the right way to legislate. This is being jammed through because I guess it is China week and God forbid we wait a couple of more weeks and get this right, but we want to get this thing done.

However, this is not the way we should be doing things around here.

What is even worse is that this bill is being brought up under suspension. People know that there are genuine concerns about this bill, and yet it is being brought up under suspension. We have no opportunity to amend it or to make improvements. There is no process through the Rules Committee, no amendments, nothing.

Believe me, Mr. Speaker, when I say that I really, really believe we can get to ``yes'' on a bill to hold bad companies accountable and to protect the American people. I think we could get ``yes'' to a bill that would not only have my support but the support of everybody in this Chamber. This is just take it or leave it, and I think the best thing for all of us to do is to leave it and go back to the drawing board and to come up with something better that we can get to the floor in the next several days or in the next couple of weeks.

I have spent my entire career standing up to the Chinese Communist Party and to the PRC, and I have the battle scars to prove it. Yes, I do have a company in my district that is actually named in this bill, but that is not the only reason why I am here.

I am here because I care about these issues. I have cared about these issues for a long time. Yes, I did my due diligence on the company in my district and asked why they were included. That is not a radical question, it is not a tough question, and nobody can really tell me. I got a different answer every time I asked. Not in a classified setting and not in an unclassified setting can anybody still give me a straight answer. In fact, I have been given multiple conflicting reasons.

This should be easy. This company is on a list because they are doing X, Y, and Z, and we have the proof.

I have never heard that.

Maybe some of the concerns apply to some of these companies. I have no idea, and nobody, including the people who wrote this bill, could give me a clear answer on the basic question of why some entities are named and others are not.

Then, once they are named in this bill, the five companies that are named, I am told that it is literally impossible for them to get off the list. If one of these five companies does not belong on the list, then too bad, Congress doesn't like you, and that is that.

Let me be crystal clear. If a thorough interagency review concludes that any of these named companies, including the one in my district, are engaged in behavior that endangers our national security or violates people's privacy, then I will be the first in line to say: Shut them down.

However, without that process, again, this is how they do things in China. It shouldn't be how we do things in the United States.

I strongly urge a ``no'' vote, and I pledge that if this bill is defeated or if my friends pull it, I will proudly work to come up with a better bill that will actually get the job done and not create a slippery slope that we should not be going down.

We have other standing committees that should have been involved in drafting this bill, quite frankly, that have expertise on these matters: Foreign Affairs, Energy and Commerce, Ways and Means, Homeland Security, and Intelligence. They should have been consulted and at the table here. It should have been more than the Select Committee and the Oversight and Accountability Committee.

Let's do this in a better way. Let's create a fully vetted list that goes through an interagency process, not a flawed bill that has major enforcement problems that I believe will actually hurt us in opposing PRC's activities.

Let's pull this bill or defeat this bill, and let's get this right. We have an opportunity to get it right. Let's get it right, and we will get it to the floor in a matter of days.

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Mr. McGOVERN. First of all, WuXi AppTec and WuXi Biologics are two separate entities. Again, I was hoping to get some more clarity, and this is what puzzles me as to why WuXi Biologics is on this list. I was told at one point that they were on the list because the Department of Commerce had them on the unverified list.

I actually had a conversation with the Department of Commerce to try to understand all these different lists, and they told me that it is not uncommon for companies to be on the unverified list, especially in the aftermath of COVID because it was hard to do the investigations. However, then they sent me a statement in which WuXi Biologics was removed from the unverified list.

Then I said: Well, they must be on another list.

They said that they had this thing called the entity list.

I asked them, I said that they must be on the entity list if they are named in this bill. The entity list is made up of foreign individuals, companies, and organizations deemed a national security concern subjecting them to export restrictions and licensing requirements for certain technologies and goods, so they must be on that list.

The Commerce Department said: No, they are not on that list.

I said: Okay, they are not on the unverified list, and they are not on the entity list.

Is there any other list out there?

Well, there is another one out there. It is the DOD section 1260H list.

Are they on that list?

I am told: No, they are not on that list either.

The section 1260H list is made up of Chinese military companies operating directly or indirectly in the United States in accordance with the statutory requirement of section 1260H of the National Defense Authorization Act for fiscal year 2021.

They are not on any of those lists. They are not on any of those lists.

Then here is the deal: If they don't belong in the underlying legislation, then there is no way to get off the list. There is no way for them to get off the list. I was told, with all due respect by the ranking member, and I have checked with our Senate colleagues and with Commerce, that those that are named cannot get off the list.

All I am simply saying is that--maybe I am missing something here--we ought to have an interagency review and thorough investigation before we start implementing these kinds of sanctions.

Again, this is what they do in China. This is not what we are supposed to do in the United States. Due process actually matters here. The truth should matter here.

Again, some of these companies absolutely may belong on this list, but I am just simply saying that I have questions that have not been answered either in a classified or unclassified setting, and they have certainly not been satisfied by members of the committee.

This is a very strange debate. Again, are we all comfortable moving forward in a way that doesn't require any thoughtful or interagency investigation or process? You know, a process with integrity, by the way, will result in any of the bad actors getting on the list. That is what an interagency process is supposed to be about.

Our friends still haven't really told me the criteria they use to get people on their blacklist, except the gentleman from Ohio just said if I want to say that you are bad, then you are on the list. That is not the way we do things in the United States. I hope we never will do that in the United States. That is the way they do things in China.

Again, as I stated before, WuXi Biologics is distinct from WuXi AppTec, but during China week, anything with a Chinese name is somehow suspect and somehow bad.

Mr. Speaker, I include in the Record an article from InsideHealthPolicy, ``Cutting Foreign Ties Could Lead To Drug Supply Chain Disruptions, Industry Warns.'' [From InsideHealthPolicy, May 21, 2024] Cutting Foreign Ties Could Lead to Drug Supply Chain Disruptions, Industry Warns (By Maaisha Osman)

As House committees advance bills that would bar American companies from working with some foreign-owned biotechnology companies in the future, industry experts warn ending pharmaceutical relationships with China could lead to drug shortages and supply chain disruptions.

Darius Lakdawalla, director of research at University of Southern California Schaeffer Center for Health Policy and Economics, said at the U.S. Pharma and Biotech Summit Thursday (May 16) that cutting ties with foreign companies could worsen supply chain issues in the United States.

``I think the Chinese issue, there's no question that that's going to increase the risk of shortages and supply chain disruption, how could it not do those things?'' Lakdawalla said. ``And that's a particularly problematic issue in a moment when there's a lot of political pressure against the pharmaceutical industry (and) the last thing we need to see now is consumers (being) unable to fill their prescriptions at the pharmacy because of shortages.''

Biogen's CEO, Chris Viehbacher, highlighted during the Thursday summit that drug company CEOs traditionally did not need to consider geopolitical issues, but this is now beginning to change.

``You know, amongst the CEOs we are suddenly saying, `Hey, we haven't needed to think about geopolitics in years,' '' Viehbacher said. ``When I was CEO of Sanofi, those were the peak years of globalization, we could move products and people and capital all around the world and not even think about borders, and that's clearly changing.''

Other executives also expressed discomfort with thinking about their business in national security terms.

``When we think about the BIOSECURE Act, I think Chris Viehbacher said it best which is, if it's in the form of a national security threat, that is one place that industry does not want to get in into,'' Harmeet Dhillon, head of public policy at Glaxo Smith Kline, said, referring to the legislation moving forward in the House. ``We want to let that be handled by the appropriate experts from a policy and political perspective.''

Viehbacher also noted that national security concerns are driven by mistrust between the East and West and the bipartisan support for the bill underscores the seriousness of these concerns.

``East-West divide has created a mistrust and that is driving a number of the national security concerns,'' he said. ``This is a bill that has extremely strong bipartisan support and if you can get Democrats and Republicans to agree on anything, that something must be serious.''

If passed by the House and Senate and signed into law, the BIOSECURE Act would prohibit federal agencies from contracting or procuring equipment or services from ``biotechnology companies of concern.'' This includes any company that is ``subject to the jurisdiction, direction, control, or operates on behalf of the government of a foreign adversary'' and poses a biotechnology security risk. Adversaries include China, North Korea, Russia, and Iran.

The most recent version of the bill in the House extends the deadline for U.S. companies to terminate their collaborations with specific Chinese entities until 2032. Additionally, it includes WuXi Biologics, a subsidiary of the targeted pharmaceutical company WuXi Apptec, on the list of companies of concerns.

The New York Times reported that WuXi is involved in manufacturing about 25% of drugs sold in the United States. The leukemia treatment Imbruvica, for example, is sold by Janssen Biotech and AbbVie, but WuXi makes its active pharmaceutical ingredient (API).

``The reality is that a company like WuXi has been an extremely cost-effective and capable supplier to our industry,'' Viehbacher said at the Thursday summit. ``It's not even going to be that easy to replace that capability either in the United States or in other countries.''

``It is a big market, but I think we're going to have to imagine a border there that we haven't had to think about in the past,'' Viehbacher added.

At a STAT event in November, industry experts said that domestic manufacturing can very easily become ``a feel-good strategy,'' but onshoring a drug's API wouldn't solve the drug shortage crisis.

``We need to be very strategic on what we onshore,'' Marta Wosinska, senior fellow at the Brookings Institution's Center on Health Policy, said. For example, Wosinska cautioned that the United States shouldn't onshore an API manufacturer for a drug where all the upstream manufacturing still comes from China.

``That wouldn't solve the problem,'' she said.

Wosinska also noted that domestic drug manufacturing does not necessarily mean higher quality. She pointed out that historically drug shortages were primarily caused by manufacturing quality problem in U.S.-based facilities.

Meanwhile, FDA drug center chief Patrizia Cavazzoni said at an Alliance for Stronger FDA webinar May 6 the agency is focused on enhancing the resilience of the manufacturing supply chain and does not want manufacturers to stop production because of issues identified during inspections.

``When investigators understand the context of a facility and what is being manufactured there, we strongly encourage manufacturers not to stop manufacturing or halt operations as a result of inspections,'' Cavazzoni said. ``Even during inspections, we sometimes see manufacturers say they will hold off and shut down a line because of what they are hearing during the inspections.''

As a part of FDA's initiative to modernize inspections, the agency is testing a program aimed at improving communication among investigators, the drug shortage team and the compliance team. This enhanced communication would occur continuously, spanning before, during, and after inspections. The goal is to provide investigators with contextual understanding of the facility's manufacturing activities.

``We really want manufacturers to call our drug shortage surveillance team immediately because we want to start problem-solving with manufacturers as soon as possible during the inspection to put in place mitigation approaches that will prevent outright stoppages of manufacturing essential drugs, as we have witnessed over the past year,'' Cavazzoni said.

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Mr. McGOVERN. Mr. Speaker, I point that out because we have to be very careful on how we proceed, to make sure we are going after truly bad actors so we don't disrupt the supply chain in which we see a disruption in pharmaceuticals, which means higher prices and less availability. That is something that ought to be talked about. It would be nice if the Energy and Commerce Committee were part of this discussion because I think that is relevant.

Again, I have no problem with holding anybody accountable. I would just like a process that has integrity.

With due respect to the gentleman who just spoke, your word doesn't cut it. I want a little bit more verification that, in fact, what we are doing is right. If the verification is there, I am with you.

We can get there. We can do this in a better way, one that upholds our values and one that holds these companies accountable, and we can go in a way that would have broad bipartisan support.

Just to respond to the gentleman from Michigan, I didn't say I had done my due diligence and that there is no connection. I said they are two separate entities. I said we should have a process in place that has integrity that everyone has confidence in to do the due diligence to make sure, in fact, that the companies that are being named do, in fact, deserve to be named.

Experts, by the way, in my State tell me that we do not have enough domestic capacity to pick up the slack if the named companies were barred from doing business with the U.S. today.

Clearly, we need to increase our domestic drug production capacity and quality. The Federal Government should incentivize domestic biotech companies to manufacture products like active pharmaceutical ingredients and key starting materials to help ensure the security of our supply chains. We could better support workforce development by providing funding for regional training centers and efforts to diversify the workforce.

These are just some suggestions based on the feedback that I have received. The bottom line is we need to make some changes to improve capacity at home.

As we are going after the bad actors, let's also figure out how to increase capacity at home. All I am saying is--let me repeat--if any or all of these companies deserve to be sanctioned, I am there. I just want a process that has integrity and that is worthy of this institution.

It seems to me it is not that difficult to get there, but I guess in the effort to try to comply with China week and to get a press release out, we are naming companies without really any thorough and thoughtful process. I worry that it is a slippery slope that will be replicated in other instances.

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Mr. McGOVERN. Mr. Speaker, may I ask the gentleman how many more speakers he has.

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Mr. McGOVERN.

Mr. Speaker, I should point out for the record that WuXi Biologics did a third-party audit, which indicates that they don't contain any biogenetic information.

Again, all I am asking for here is a process that is above question. I do think there is something to be said to make sure that we get it right.

This idea that we may not get it right and it is too bad for a company, it is too bad for the people who work there, it is too bad for the supply chain, and we will see prescription drugs go up for no reason just because we are lazy and we don't want to do a full audit, I am sorry. Democrats and Republicans should agree that process matters.

Again, we are not China. We are the United States of America. We do things in a transparent and open way. I don't think it is unreasonable to be here saying we ought to have a thorough process that these companies are subjected to and that all others are. If any of these companies or any others are deemed to be in collaboration with the Chinese Communist Party or PRC or whoever else you don't like, and there is sharing of sensitive information or behaving in a way that is unscrupulous and in violation of our laws, then we should hold them accountable. There is no question about that.

It is about this bill and about the lack of process and the lack of transparency.

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Mr. McGOVERN. Mr. Speaker, may I inquire as to how much time is remaining.

Mr. Speaker, it is so disappointing that we are here having this debate. With all due respect to the gentleman from Illinois (Mr. Krishnamoorthi), the idea that we are blacklisting a company that is not on any list in the Commerce Department or in the Defense Department and we are just doing it because Members don't like who they have been affiliated with over the years is really quite irresponsible.

Companies ought to be sanctioned that have done something wrong. WuXi Biologics did a third-party audit, and, again, they contained no biogenetic information. That is what the audit revealed. It doesn't really make any difference.

By the way, they can't get off the list. They can't get off the list because of how this bill is written. There is no remedy for them if my colleagues are wrong. Is that what we do in Congress? My colleagues don't like the name of a company. It is a Chinese name, and so automatically they have to be guilty of all the worst things that can be thought of.

Some of these companies might, but some of them might not be. That is why process matters. All of us, Democrats and Republicans, should want a thorough process, so that when we come here, we are speaking with one voice.

Again, some of these companies that the gentleman has put in his bill may, in fact, be justified, but let's do the process. Let's get this right. Why is that such a controversial thing?

The only thing I can think of is because Members are trying to rush to comply with China week and not trying to get legislation right. Committees of jurisdiction, the Intelligence Committee, the Foreign Affairs Committee, the Ways and Means Committee, the Energy and Commerce Committee, all of them, should be at the table working with my colleagues on this legislation, but they weren't. They weren't.

This is not the way we should address this very serious matter. I have been talking about the issue of China's unscrupulous business activities for years and years. I want to get this right. I want to get this right. I want to get it right in a way where we can't be accused of just blacklisting companies because we don't like their last name.

There is a better way to do this. Quite frankly, we tried to work with Members on a better way, but my colleagues had no interest in working with us on a better way. I regret that because I wouldn't be here today, and I think you would have a unanimous vote.

I think people are concerned about the process, and process matters. We are not China. We are the United States of America. We are better. We are transparent. We employ and embrace open processes for the world to see.

If any of these companies are engaged in activities that are objectionable, let's hold them accountable, but it should be as the result of a thorough process.

Again, I will close by saying I am one of the few persons here who is sanctioned by China, who cannot travel there. My family can't travel there according to their press release. They don't like me at all. The reason why they don't is because we have passed legislation that has been effective and that has worked.

We have an opportunity to do that here. There are no amendments. This bill has been brought to the floor that really has all these incredible consequences. There are no amendments allowed. There has been no input from other committees. Here, take it or leave it.

We ought to leave it and go back to the drawing board and get this right. We could figure this out in a matter of days. We can get this right. Let's do it. Let's do it, and let's do it in a way that holds China to account.

The final thing I will say is what we have been hearing from the regulatory agencies, that by naming these companies in a bill, you are giving them the heads up. They can change their name and reincorporate in the Cayman Islands and come back, and we are playing whack-a-mole with them. There is a better way to do this. Let us work together and get there.

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Mr. McGOVERN. Mr. Speaker, on that I demand the yeas and nays.

The yeas and nays were ordered.

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