cawacko
Well-known member
This is an opinion piece from someone who consults with the pharamcutical industry so they may be very biased, or could possibly just be knowledgable on the subject and can see past the bill's name. Anyone here knowledgable in this space? If yes, thoughts on this? Is this just another bill by our gov't to make it look like we are trying to do something? Or is there real teeth here?
Last week, the Biosecure Act, a bipartisan bill that would prohibit American agencies from working with several Chinese biotech companies and would require U.S. companies to sever their contracts by 2032, overwhelmingly passed in the House Committee on Oversight and Accountability. The bill’s supporters believe that China is developing bioweapons using genomic data on Americans obtained from these companies. One of the bill’s co-sponsors, Rep. Raja Krishnamoorthi, D-Ill., said in a statement that the Biosecure Act ensures “our supply chains are free from interference and manipulation by countries that wish to do us harm.”
While the act sounds like it is in the interest of national health security, it likely will do more harm than good.
The U.S. drug supply is inexorably linked to China. Most biotech and pharma companies use Chinese contract drug manufacturing organizations to obtain raw materials, components and active pharmaceutical ingredients. A recent survey by the Biotechnology Innovation Organization found that of 124 biopharma companies surveyed, 79% had China-based or owned manufacturing partners.
While the Biosecure Act specifically calls out four Chinese contract drug manufacturing organizations, it also prohibits contracting with any firm that has ties to the Chinese government — which is potentially every Chinese company because China’s national security laws require all the country’s firms to share any requested data with the government.
Given how intertwined U.S. biotech is with its Chinese counterparts, the bill’s stipulations are not feasible without severely impacting the industry and potentially grinding it to a halt.
Some companies have already begun warning their shareholders of potential fallout from the act. San Carlos-based Iovance Biotherapeutics, maker of the melanoma therapy Amtagvi that relies on WuXi, one of the blacklisted companies, said as much in its 2023 annual report: “Current geopolitical tensions with China may impact our ability to expand manufacturing capacity at our contract manufacturer, WuXi.” Emeryville-based Kyverna Therapeutics also indicated its use of WuXi to manufacture its autoimmune drug candidates would be impacted. Popular weight loss drugs like Eli Lily’s Mounjaro are also manufactured in part by Wuxi and likely would have a supply shortage resulting in price hikes.
If the bill becomes law, the reverberations won’t just be felt by patients. Some companies that would fall under the act’s purview have offices and manufacturing locations in the United States. Wuxi Apptec, for example, is headquartered near Shanghai but has 1,700 employees in the U.S., including at a manufacturing site in Hayward. It’s easy to see how the bill’s passage could lead to job losses or even a complete shuttering of these sites.
In truth, if there was a credible national security concern with Chinese biotech companies stealing genomic and other biological data on Americans, the Biosecure Act would do little to address it. As any high school advanced placement biology student knows, there is nothing in human DNA that points to an individual’s nationality. Moreover, human DNA sequences have long been publicly available to anyone interested in them. Legislation would instead be needed at a much higher level of trade, prohibiting Chinese entities from forming operations or acquiring businesses in the U.S. altogether.
If U.S. lawmakers had legitimate concerns about the misuse of American biological data, the controls would need to primarily be in the information technology sector. Hospitals, clinical laboratories, DNA sequencing companies, government agencies and law enforcement all collect, store and transmit magnitudes more biological data in electronic form. Data breaches via internet hacks or direct espionage and the sale of such large data sets would be the likely risk and where it might make sense for more legislative and regulatory oversight.
Given only a very small class of drugs contain human genomic data in the manufacturing process, it is hard to imagine what could be done with this information that would yield a threat to the American public. Moreover, since Chinese biotech and pharma companies already run clinical trials in the U.S. with the intent of pursuing drug approval through the U.S. Food and Drug Administration, they already have a legal pathway to directly obtain human biological information which the act does not consider.
If the goal of lawmakers is to prevent the Chinese government from obtaining and misusing American technological secrets and data, then the Biosecure Act is too narrow. China already has far more efficient means to collect information on us — be it through social media apps like TikTok or other industries, like the acquisition of Smithfield Foods in 2013 by Shuanghui Group.
It would not be surprising if the real push behind the act is by lobbyists and special interest groups in the industry wanting to drive more drug manufacturing back to the United States. To be clear, that is a laudable goal. As we learned through the pandemic, decades of offshoring critical capabilities such as vaccine and personal protective equipment manufacturing resulted in a dire supply shortage for this country. However, the way to achieve this is not by disrupting drug development and manufacturing through fear-based and anti-capitalistic trade prohibitions, but rather by creating more economic incentives for American companies to establish manufacturing operations here.
Chirag Asaravala is co-founder of GxPBase Consulting Group, which has clients in the biotech and pharmaceutical industries.
Lawmakers say a new biosecurity bill will protect us from China. They’re wrong
Last week, the Biosecure Act, a bipartisan bill that would prohibit American agencies from working with several Chinese biotech companies and would require U.S. companies to sever their contracts by 2032, overwhelmingly passed in the House Committee on Oversight and Accountability. The bill’s supporters believe that China is developing bioweapons using genomic data on Americans obtained from these companies. One of the bill’s co-sponsors, Rep. Raja Krishnamoorthi, D-Ill., said in a statement that the Biosecure Act ensures “our supply chains are free from interference and manipulation by countries that wish to do us harm.”
While the act sounds like it is in the interest of national health security, it likely will do more harm than good.
The U.S. drug supply is inexorably linked to China. Most biotech and pharma companies use Chinese contract drug manufacturing organizations to obtain raw materials, components and active pharmaceutical ingredients. A recent survey by the Biotechnology Innovation Organization found that of 124 biopharma companies surveyed, 79% had China-based or owned manufacturing partners.
While the Biosecure Act specifically calls out four Chinese contract drug manufacturing organizations, it also prohibits contracting with any firm that has ties to the Chinese government — which is potentially every Chinese company because China’s national security laws require all the country’s firms to share any requested data with the government.
Given how intertwined U.S. biotech is with its Chinese counterparts, the bill’s stipulations are not feasible without severely impacting the industry and potentially grinding it to a halt.
Some companies have already begun warning their shareholders of potential fallout from the act. San Carlos-based Iovance Biotherapeutics, maker of the melanoma therapy Amtagvi that relies on WuXi, one of the blacklisted companies, said as much in its 2023 annual report: “Current geopolitical tensions with China may impact our ability to expand manufacturing capacity at our contract manufacturer, WuXi.” Emeryville-based Kyverna Therapeutics also indicated its use of WuXi to manufacture its autoimmune drug candidates would be impacted. Popular weight loss drugs like Eli Lily’s Mounjaro are also manufactured in part by Wuxi and likely would have a supply shortage resulting in price hikes.
If the bill becomes law, the reverberations won’t just be felt by patients. Some companies that would fall under the act’s purview have offices and manufacturing locations in the United States. Wuxi Apptec, for example, is headquartered near Shanghai but has 1,700 employees in the U.S., including at a manufacturing site in Hayward. It’s easy to see how the bill’s passage could lead to job losses or even a complete shuttering of these sites.
In truth, if there was a credible national security concern with Chinese biotech companies stealing genomic and other biological data on Americans, the Biosecure Act would do little to address it. As any high school advanced placement biology student knows, there is nothing in human DNA that points to an individual’s nationality. Moreover, human DNA sequences have long been publicly available to anyone interested in them. Legislation would instead be needed at a much higher level of trade, prohibiting Chinese entities from forming operations or acquiring businesses in the U.S. altogether.
If U.S. lawmakers had legitimate concerns about the misuse of American biological data, the controls would need to primarily be in the information technology sector. Hospitals, clinical laboratories, DNA sequencing companies, government agencies and law enforcement all collect, store and transmit magnitudes more biological data in electronic form. Data breaches via internet hacks or direct espionage and the sale of such large data sets would be the likely risk and where it might make sense for more legislative and regulatory oversight.
Given only a very small class of drugs contain human genomic data in the manufacturing process, it is hard to imagine what could be done with this information that would yield a threat to the American public. Moreover, since Chinese biotech and pharma companies already run clinical trials in the U.S. with the intent of pursuing drug approval through the U.S. Food and Drug Administration, they already have a legal pathway to directly obtain human biological information which the act does not consider.
If the goal of lawmakers is to prevent the Chinese government from obtaining and misusing American technological secrets and data, then the Biosecure Act is too narrow. China already has far more efficient means to collect information on us — be it through social media apps like TikTok or other industries, like the acquisition of Smithfield Foods in 2013 by Shuanghui Group.
It would not be surprising if the real push behind the act is by lobbyists and special interest groups in the industry wanting to drive more drug manufacturing back to the United States. To be clear, that is a laudable goal. As we learned through the pandemic, decades of offshoring critical capabilities such as vaccine and personal protective equipment manufacturing resulted in a dire supply shortage for this country. However, the way to achieve this is not by disrupting drug development and manufacturing through fear-based and anti-capitalistic trade prohibitions, but rather by creating more economic incentives for American companies to establish manufacturing operations here.
Chirag Asaravala is co-founder of GxPBase Consulting Group, which has clients in the biotech and pharmaceutical industries.