In an announcement on May 11, US President Donald Trump revealed plans to sign an executive order that will drastically reduce the cost of prescription drugs for Americans.
The order, set to be signed at 9:00 am (US EST) on May 12, will implement a &ldquo;most favoured nation&rdquo; (MFN) policy, which ties the US price of prescription drugs to the lowest price paid for the same medications by any other country in the world. Trump asserts that this move could cut drug prices by as much as 30 per cent to 80 per cent, offering relief to millions of American consumers who face some of the highest pharmaceutical costs globally.
In a social media post on Truth Social, Trump framed the move as a long-overdue correction to what he described as a rigged system that has burdened US citizens with excessively high drug prices. He explained that, while drug prices in the US are sometimes five to ten times higher than in other nations, American consumers have had little to no recourse.
Trump blamed pharmaceutical companies for using research and development (R&amp;D) costs as a rationale for the pricing disparity, suggesting that these costs were disproportionately &ldquo;borne by the &lsquo;suckers&rsquo; of America, alone&rdquo;.
&ldquo;For many years, the world has wondered why prescription drugs and pharmaceuticals in the United States were so much higher in price than they were in any other nation,&rdquo; Trump said in his social media post. &ldquo;Sometimes being five to ten times more expensive than the same drug, manufactured in the exact same laboratory or plant, by the same company.&rdquo;
The announcement came as a direct challenge to the pharmaceutical industry's lobbying efforts and an ongoing debate over US drug pricing. The industry, led by trade group PhRMA, has consistently argued against government-imposed price controls, claiming they undermine innovation and hurt patients by limiting access to new treatments. Despite this, Trump insisted that the pharmaceutical sector&rsquo;s arguments about the negative impact on innovation were embarrassing and unfounded.
According to Trump, this policy would not only ensure fairness for American consumers but would also bring about global pricing changes, leading to higher prices abroad in order to &ldquo;equalise&rdquo; the global pharmaceutical market.
&ldquo;This is the kind of fairness we&rsquo;ve been fighting for. The United States will finally be treated fairly,&rdquo; Trump said in his post. &ldquo;We will save trillions of dollars, and our citizens&rsquo; healthcare costs will be reduced by numbers never even thought of before.&rdquo;
<h2 dir="ltr">The background</h2>
The policy follows a pattern from Trump&rsquo;s first term, when he sought to tackle drug pricing by introducing a &ldquo;Most Favoured Nation&rdquo; policy that would have linked the prices of certain drugs to those paid by other developed nations. The initiative, which sought to lower the price of drugs administered in doctor&rsquo;s offices, was met with fierce opposition from the pharmaceutical industry and ultimately blocked by federal courts.
The Biden administration chose not to pursue the policy further, opting instead to include drug price negotiations for Medicare under the Inflation Reduction Act of 2022.
Trump&rsquo;s latest announcement appears to build upon his earlier efforts, proposing a more expansive application of MFN pricing that could impact a broader range of drugs.
Despite the anticipated benefits for American consumers, the move has drawn sharp criticism from several quarters, including some senior Republicans and industry leaders.
Trump, however, dismissed these concerns, suggesting that the pharmaceutical industry had long manipulated the system to its benefit and that the costs of R&amp;D were inflated as a means of justifying excessive drug prices. He emphasised that the policy would bring substantial savings to both the federal government and individual consumers, ultimately benefiting American taxpayers.
While the policy&rsquo;s details remain unclear, it is widely expected that the MFN pricing would apply primarily to Medicare, the government health insurance program for seniors. Under the 2020 proposal, which was struck down by courts, Medicare would have paid the lowest price available for certain drugs among a group of 22 peer nations, including France and Japan.
The US pharmaceutical industry, however, strongly opposed the idea of linking US drug prices to those in other countries, arguing that foreign governments impose strict price controls that suppress competition and innovation. Drugmakers contend that higher prices in the US help fund research and the development of new therapies. Critics of the MFN approach argue that it would lead to higher costs in other countries and could result in shortages of certain medications.
The Trump administration&rsquo;s 2020 proposal faced a similar backlash and was eventually blocked by federal courts. However, Trump&rsquo;s team is determined to push the policy forward, citing the benefits to both American taxpayers and patients. Additionally, there is growing pressure within the administration to reduce the overall cost of prescription drugs, which remain one of the largest expenses for US households.
<h2 dir="ltr">Challenges ahead?</h2>
It remains to be seen whether Trump&rsquo;s new executive order will face similar legal challenges as its predecessor or whether it will be implemented without significant opposition. Experts warn that the road ahead could be fraught with legal hurdles, and some analysts remain sceptical about the effectiveness of such a policy.
As the situation unfolds, the debate over drug pricing in the US is likely to intensify, with both sides of the argument preparing for a lengthy legal and political battle. Whether Trump&rsquo;s proposal succeeds in lowering costs for Americans remains uncertain, but one thing is clear: prescription drug prices will be a central issue for the foreseeable future.
For now, Americans are left wondering whether the president&rsquo;s bold claims about cutting drug prices by as much as 80 per cent will materialise into a reality or if they will become yet another point of contention in the ongoing struggle over US healthcare reform.
(With inputs from agencies)

Business & Economy: Trump asserts that this move could cut drug prices by as much as 30 per cent to 80 per cent, offering relief to millions of American consumers.

In an announcement on May 11, US President Donald Trump revealed plans to sign an executive order that will drastically reduce the cost of prescription drugs for Americans. The order, set to be signed at 9:00 am (US EST) on May 12, will implement a “most favoured nation” (MFN) policy, which ties the US price of prescription drugs to the lowest price paid for the same medications by any other country in the world. Trump asserts that this move could cut drug prices by as much as 30 per cent to 80 per cent, offering relief to millions of American consumers who face some of the highest pharmaceutical costs globally. In a social media post on Truth Social, Trump framed the move as a long-overdue correction to what he described as a rigged system that has burdened US citizens with excessively high drug prices. He explained that, while drug prices in the US are sometimes five to ten times higher than in other nations, American consumers have had little to no recourse. Trump blamed pharmaceutical companies for using research and development (R&D) costs as a rationale for the pricing disparity, suggesting that these costs were disproportionately “borne by the ‘suckers’ of America, alone”. “For many years, the world has wondered why prescription drugs and pharmaceuticals in the United States were so much higher in price than they were in any other nation,” Trump said in his social media post. “Sometimes being five to ten times more expensive than the same drug, manufactured in the exact same laboratory or plant, by the same company.” The announcement came as a direct challenge to the pharmaceutical industry's lobbying efforts and an ongoing debate over US drug pricing. The industry, led by trade group PhRMA, has consistently argued against government-imposed price controls, claiming they undermine innovation and hurt patients by limiting access to new treatments. Despite this, Trump insisted that the pharmaceutical sector’s arguments about the negative impact on innovation were embarrassing and unfounded. According to Trump, this policy would not only ensure fairness for American consumers but would also bring about global pricing changes, leading to higher prices abroad in order to “equalise” the global pharmaceutical market. “This is the kind of fairness we’ve been fighting for. The United States will finally be treated fairly,” Trump said in his post. “We will save trillions of dollars, and our citizens’ healthcare costs will be reduced by numbers never even thought of before.” The background The policy follows a pattern from Trump’s first term, when he sought to tackle drug pricing by introducing a “Most Favoured Nation” policy that would have linked the prices of certain drugs to those paid by other developed nations. The initiative, which sought to lower the price of drugs administered in doctor’s offices, was met with fierce opposition from the pharmaceutical industry and ultimately blocked by federal courts. The Biden administration chose not to pursue the policy further, opting instead to include drug price negotiations for Medicare under the Inflation Reduction Act of 2022. Trump’s latest announcement appears to build upon his earlier efforts, proposing a more expansive application of MFN pricing that could impact a broader range of drugs. Despite the anticipated benefits for American consumers, the move has drawn sharp criticism from several quarters, including some senior Republicans and industry leaders. Trump, however, dismissed these concerns, suggesting that the pharmaceutical industry had long manipulated the system to its benefit and that the costs of R&D were inflated as a means of justifying excessive drug prices. He emphasised that the policy would bring substantial savings to both the federal government and individual consumers, ultimately benefiting American taxpayers. While the policy’s details remain unclear, it is widely expected that the MFN pricing would apply primarily to Medicare, the government health insurance program for seniors. Under the 2020 proposal, which was struck down by courts, Medicare would have paid the lowest price available for certain drugs among a group of 22 peer nations, including France and Japan. The US pharmaceutical industry, however, strongly opposed the idea of linking US drug prices to those in other countries, arguing that foreign governments impose strict price controls that suppress competition and innovation. Drugmakers contend that higher prices in the US help fund research and the development of new therapies. Critics of the MFN approach argue that it would lead to higher costs in other countries and could result in shortages of certain medications. The Trump administration’s 2020 proposal faced a similar backlash and was eventually blocked by federal courts. However, Trump’s team is determined to push the policy forward, citing the benefits to both American taxpayers and patients. Additionally, there is growing pressure within the administration to reduce the overall cost of prescription drugs, which remain one of the largest expenses for US households. Challenges ahead? It remains to be seen whether Trump’s new executive order will face similar legal challenges as its predecessor or whether it will be implemented without significant opposition. Experts warn that the road ahead could be fraught with legal hurdles, and some analysts remain sceptical about the effectiveness of such a policy. As the situation unfolds, the debate over drug pricing in the US is likely to intensify, with both sides of the argument preparing for a lengthy legal and political battle. Whether Trump’s proposal succeeds in lowering costs for Americans remains uncertain, but one thing is clear: prescription drug prices will be a central issue for the foreseeable future. For now, Americans are left wondering whether the president’s bold claims about cutting drug prices by as much as 80 per cent will materialise into a reality or if they will become yet another point of contention in the ongoing struggle over US healthcare reform. (With inputs from agencies)

Donald Trump plans major move to cut drug prices by up to 80%

India’s pharmaceutical sector, the world’s largest supplier of generic medicines, is growing at a rapid pace. According to a McKinsey report, pharmaceutical exports rose at 9% annually in 2024, nearly twice the global average. India now meets 20% of global drug demand, supplying 40% of the US Generic market and 25% of the UK market. The country has also surpassed the US In FDA-approved manufacturing sites.

India’s pharma exports grow at 9%, double the global average

In a significant industry shift, pharmaceutical companies are actively exploring alternatives to Chinese contractors for drug production, driven by concerns over geopolitical tensions and supply chain vulnerabilities. According to a Reuters report,&nbsp;industry executives and experts reveal a growing trend favouring Indian manufacturers over their Chinese counterparts.

China has been the preferred destination for pharmaceutical research and manufacturing services for nearly two decades, thanks to cost-effectiveness and rapid production capabilities offered by contract drugmakers. This relationship endured challenges from the U.S-China trade war and disruptions caused by the COVID-19 pandemic.

Changing dynamics: Seeking to 'de-risk' supply chains

Rising tensions with China have prompted Western governments to advise companies to 'de-risk' their supply chains. As a result, some biotech firms are now considering manufacturers in India to produce active pharmaceutical ingredients (API) for clinical trials and other outsourced work.

Tommy Erdei, Global Co-head of Healthcare Investment Banking at Jefferies, told Reuters, "Today, you're probably not sending an RFP to a Chinese company. It's like, I don't want to know. It doesn't matter if they can do it for cheaper, I'm not going to start putting my product into China."&nbsp;

Biotech companies turn to India: A growing trend

Dr. Ashish Nimgaonkar, the founder of Glyscend Therapeutics, told Reuters that factors over the past several years have made China a less attractive option. When issuing Requests for Proposal (RFP) for medicines in later development stages, Indian contract development and manufacturing organizations (CDMOs) are now preferred over Chinese ones.

Four of India's largest CDMOs—Syngene, Aragen Life Sciences, Piramal Pharma Solutions, and Sai Life Sciences—report increased interest and requests from Western pharma companies, including major multinationals.

While the full benefit for Indian manufacturers won't be immediate, there is a notable surge in interest. India aims to strengthen its position in the pharma services sector, boosting sales and enhancing the reputation of its $42 billion pharmaceutical industry. Despite concerns over oversight, Indian CDMOs are actively working to match Western and Chinese standards in quality.

Regulatory scrutiny and growth projections

The U.S. Food and Drug Administration (FDA) warned about an eye drop made in India in February. However, Indian CDMOs stress routine inspections by the FDA. Mordor Intelligence estimates India's CDMO industry revenue to be $15.6 billion in 2023, with a projected annual growth rate of over 11% for the next five years.

Some clients request 'backward integration to India' where even basic raw materials are sourced from India instead of China. Piramal Pharma Solutions has received such requests, indicating a broader shift in the supply chain.

Sai Life Sciences reports almost doubling its manufacturing capacity since 2019 and is set to add another 25% in the next year to meet growing demand. The industry shift is particularly evident in drug discovery work for conventional pharmaceuticals.

Bottomline

The pharmaceutical industry's move to diversify its manufacturing sources marks a pivotal moment, with Indian manufacturers poised to significantly reshape global supply chains. As tensions persist and the industry navigates geopolitical uncertainties, the landscape of pharmaceutical manufacturing is undergoing a transformative shift.

In a significant industry shift, pharmaceutical companies are actively exploring alternatives to Chinese contractors for drug production, driven by concerns over geopolitical tensions and supply chain vulnerabilities.

In a significant industry shift, pharmaceutical companies are actively exploring alternatives to Chinese contractors for drug production, driven by concerns over geopolitical tensions and supply chain vulnerabilities. According to a Reuters report, industry executives and experts reveal a growing trend favouring Indian manufacturers over their Chinese counterparts. China has been the preferred destination for pharmaceutical research and manufacturing services for nearly two decades, thanks to cost-effectiveness and rapid production capabilities offered by contract drugmakers. This relationship endured challenges from the U.S-China trade war and disruptions caused by the COVID-19 pandemic. Changing dynamics: Seeking to 'de-risk' supply chains Rising tensions with China have prompted Western governments to advise companies to 'de-risk' their supply chains. As a result, some biotech firms are now considering manufacturers in India to produce active pharmaceutical ingredients (API) for clinical trials and other outsourced work. Tommy Erdei, Global Co-head of Healthcare Investment Banking at Jefferies, told Reuters, "Today, you're probably not sending an RFP to a Chinese company. It's like, I don't want to know. It doesn't matter if they can do it for cheaper, I'm not going to start putting my product into China." Biotech companies turn to India: A growing trend Dr. Ashish Nimgaonkar, the founder of Glyscend Therapeutics, told Reuters that factors over the past several years have made China a less attractive option. When issuing Requests for Proposal (RFP) for medicines in later development stages, Indian contract development and manufacturing organizations (CDMOs) are now preferred over Chinese ones. Four of India's largest CDMOs—Syngene, Aragen Life Sciences, Piramal Pharma Solutions, and Sai Life Sciences—report increased interest and requests from Western pharma companies, including major multinationals. While the full benefit for Indian manufacturers won't be immediate, there is a notable surge in interest. India aims to strengthen its position in the pharma services sector, boosting sales and enhancing the reputation of its $42 billion pharmaceutical industry. Despite concerns over oversight, Indian CDMOs are actively working to match Western and Chinese standards in quality. Regulatory scrutiny and growth projections The U.S. Food and Drug Administration (FDA) warned about an eye drop made in India in February. However, Indian CDMOs stress routine inspections by the FDA. Mordor Intelligence estimates India's CDMO industry revenue to be $15.6 billion in 2023, with a projected annual growth rate of over 11% for the next five years. Some clients request 'backward integration to India' where even basic raw materials are sourced from India instead of China. Piramal Pharma Solutions has received such requests, indicating a broader shift in the supply chain. Sai Life Sciences reports almost doubling its manufacturing capacity since 2019 and is set to add another 25% in the next year to meet growing demand. The industry shift is particularly evident in drug discovery work for conventional pharmaceuticals. Bottomline The pharmaceutical industry's move to diversify its manufacturing sources marks a pivotal moment, with Indian manufacturers poised to significantly reshape global supply chains. As tensions persist and the industry navigates geopolitical uncertainties, the landscape of pharmaceutical manufacturing is undergoing a transformative shift.

Indian pharma manufacturers gain momentum as alternatives to Chinese partners

Following a string of deadly manufacturing mishaps, the world's biggest supplier of cheap medicine has come under heightened scrutiny. US inspectors have recently discovered extensive problems at plants controlled by some of India's largest pharmaceutical companies. The US Food and Drug Administration, which is expanding visits to Indian manufacturers, has sent warning letters and alerts to dozens of drugmakers.&nbsp;

The US Food and Drug Administration, which increased visits to Indian facilities after the relaxation of Covid-19 constraints last year, has sent alerts and warning letters to dozens of drugmakers. Inspectors described filthy working conditions at production facilities, poorly trained employees, torn paper, unattended&nbsp;customer complaints, and proof that defective pharmaceuticals were being exported to the US.

The extensive failures, documented in FDA papers obtained by Bloomberg News under the Freedom of Information Act, imply that flaws were overlooked in some Indian facilities that export to the US because factory audits were suspended for nearly two years during the pandemic. &nbsp;

The US and several other nations receive the majority of their generic medication from the South Asian country. The $50 billion industry is in the news following a slew of scandals involving smaller, privately held Indian firms, including the adulteration of cough syrup that killed scores of children in the Gambia and Uzbekistan and the export of tainted chemotherapy medications to the US.

Also read |&nbsp;<a href="https://www.wionews.com/india-news/someone-duplicated-it-indian-pharma-firm-responds-after-who-issued-alert-against-another-cough-syrup-586303">'Someone duplicated it': Indian pharma firm responds after WHO issues alert against another cough syrup</a>

Reiterating their recommendations for more regulation and a global reevaluation of supply chains in response to these deaths are public health activists. In addition to pushing for more American drugs production, the Biden administration has issued warnings over the overwhelming importation of pharmaceuticals from nations like India. The fatalities and medicine recalls also occur at a crucial moment for Prime Minister Narendra Modi's administration, which is promoting the South Asian country to investors as a competitive alternative to China for high-quality manufacturing.&nbsp;

“It’s like playing whack-a-mole,” Alice Wang, a London-based fund manager at Quaero Capital LLP, which for now has avoided investing in Indian pharma firms told Bloomberg.&nbsp;

“India is still behind China in many significant ways and some investments in the high-value-precision manufacturing spaces may end up needing a reality check,” she added.

<h2>Several warnings given</h2>

The FDA has been warning about factory standards in India for a long time. In 2019, the organisation informed Congress that, among the nations it oversaw, India had the lowest proportion of inspection results that were deemed acceptable at drug manufacturing facilities (83 per cent). The US came in second with a percentage of 93 per cent, followed by China with a percentage of 90 per cent, and the European Union with a percentage of 98 per cent. A more thorough analysis was not included in the study.

WATCH WION LIVE HERE:

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Following a string of deadly manufacturing mishaps, the world's biggest supplier of cheap medicine has come under heightened scrutiny. US inspectors have recently discovered extensive problems at plants controlled by some of India's largest pharmaceutical companies.

Following a string of deadly manufacturing mishaps, the world's biggest supplier of cheap medicine has come under heightened scrutiny. US inspectors have recently discovered extensive problems at plants controlled by some of India's largest pharmaceutical companies. The US Food and Drug Administration, which is expanding visits to Indian manufacturers, has sent warning letters and alerts to dozens of drugmakers. The US Food and Drug Administration, which increased visits to Indian facilities after the relaxation of Covid-19 constraints last year, has sent alerts and warning letters to dozens of drugmakers. Inspectors described filthy working conditions at production facilities, poorly trained employees, torn paper, unattended customer complaints, and proof that defective pharmaceuticals were being exported to the US. The extensive failures, documented in FDA papers obtained by Bloomberg News under the Freedom of Information Act, imply that flaws were overlooked in some Indian facilities that export to the US because factory audits were suspended for nearly two years during the pandemic. The US and several other nations receive the majority of their generic medication from the South Asian country. The $50 billion industry is in the news following a slew of scandals involving smaller, privately held Indian firms, including the adulteration of cough syrup that killed scores of children in the Gambia and Uzbekistan and the export of tainted chemotherapy medications to the US. Also read | 'Someone duplicated it': Indian pharma firm responds after WHO issues alert against another cough syrup Reiterating their recommendations for more regulation and a global reevaluation of supply chains in response to these deaths are public health activists. In addition to pushing for more American drugs production, the Biden administration has issued warnings over the overwhelming importation of pharmaceuticals from nations like India. The fatalities and medicine recalls also occur at a crucial moment for Prime Minister Narendra Modi's administration, which is promoting the South Asian country to investors as a competitive alternative to China for high-quality manufacturing. “It’s like playing whack-a-mole,” Alice Wang, a London-based fund manager at Quaero Capital LLP, which for now has avoided investing in Indian pharma firms told Bloomberg. “India is still behind China in many significant ways and some investments in the high-value-precision manufacturing spaces may end up needing a reality check,” she added. Several warnings given The FDA has been warning about factory standards in India for a long time. In 2019, the organisation informed Congress that, among the nations it oversaw, India had the lowest proportion of inspection results that were deemed acceptable at drug manufacturing facilities (83 per cent). The US came in second with a percentage of 93 per cent, followed by China with a percentage of 90 per cent, and the European Union with a percentage of 98 per cent. A more thorough analysis was not included in the study. WATCH WION LIVE HERE:

Indian pharma industry in doldrums? US FDA reports contamination in factories

The US Federal Trade Commission (FTC) on Tuesday filed a lawsuit on Tuesday seeking to block Amgen Inc.'s proposed $27.8 billion acquisition of Horizon Therapeutics Plc. The US trade regulator has alleged&nbsp;that the merger would create a monopoly for medications treating thyroid eye disease and chronic refractory gout, hampering competition and potentially leading to higher drug prices.

According to the sealed complaint filed in Illinois Federal Court, the acquisition would allow Amgen to further solidify Horizon's dominant position in the market. The FTC's complaint has&nbsp;sought&nbsp;an injunction to halt the merger until the commission could&nbsp;proceed with an in-house trial to determine whether the proposed deal violates&nbsp;antitrust law.

While opposing Amgen's billion-dollar deal, FTC's Competition Bureau Director&nbsp;Holly Vedova&nbsp;has emphasised the need for preventing pharmaceutical companies&nbsp;from consolidating&nbsp;monopolies.&nbsp;“Rampant consolidation in the pharmaceutical industry has given powerful companies a pass to exorbitantly hike prescription drug prices, deny patients access to more affordable generics, and hamstring innovation in life-saving markets,” Bloomberg quoted Vedova as saying.&nbsp;

Amgen, however, has countered FTC's allegations, stating that the claim of a potential 'multiproduct discount' was speculative and did not align with the competitive dynamics of the real world, a Bloomberg report noted. Horizon Therapeutics has also issued a statement, denying claims made&nbsp;by the US trade regulator.&nbsp;

'Multiproduct discount' is a monopolistic practice&nbsp;often frowned upon by the market. While it gives multiple products in one bundle at cheaper rates, this practice often&nbsp;forces smaller competitors to exit the market in the long run.&nbsp;

FTC vs. Big Pharma&nbsp;

This lawsuit marks the first time since 2009 that the FTC has taken legal action to prevent a pharmaceutical merger. In the past, the agency typically allowed mergers to proceed on the condition that the companies divested any overlapping treatments. However, under the leadership of Lina Khan, the US trade regulator has adopted a more stringent approach, challenging high-profile deals such as Microsoft Corp.'s proposed acquisition of Activision Blizzard Inc. and Intercontinental Exchange Inc.'s purchase of Black Knight Inc, a mortgage software rival.

Amgen, a prominent player in the pharmaceutical industry with 27 approved drugs, including popular treatments for rheumatoid arthritis and psoriasis, now faces scrutiny over its acquisition strategy. On the other hand, Horizon Therapeutics distributes 11 drug products in the US, including Tepezza, which is used to treat thyroid eye disease, and Krystexxa, a medication&nbsp;for chronic refractory gout. These medications currently enjoy a lack of competition in the market, generating significant revenue for Horizon in 2022 — $1.97 billion for Tepezza and $716 million for Krystexxa, as reported in company filings.

Under the Biden administration, the regulator&nbsp;has closely examined mergers, conduct, and pricing practices within the hospital, physician practice, pharmaceutical, and medical device sectors. Its scrutiny has resulted in five hospitals abandoning their merger plans&nbsp;in the past two years. Additionally, the FTC has launched investigations into pharmaceutical benefit managers like Cigna Group's Express Scripts and CVS Health Corp.'s Caremark to explore their potential role in driving up drug prices.

(With agency inputs)&nbsp;

The US Federal Trade Commission (FTC) on Tuesday filed a lawsuit on Tuesday seeking to block Amgen Inc.'s proposed $27.8 billion acquisition of Horizon Therapeutics Plc.

The US Federal Trade Commission (FTC) on Tuesday filed a lawsuit on Tuesday seeking to block Amgen Inc.'s proposed $27.8 billion acquisition of Horizon Therapeutics Plc. The US trade regulator has alleged that the merger would create a monopoly for medications treating thyroid eye disease and chronic refractory gout, hampering competition and potentially leading to higher drug prices. According to the sealed complaint filed in Illinois Federal Court, the acquisition would allow Amgen to further solidify Horizon's dominant position in the market. The FTC's complaint has sought an injunction to halt the merger until the commission could proceed with an in-house trial to determine whether the proposed deal violates antitrust law. While opposing Amgen's billion-dollar deal, FTC's Competition Bureau Director Holly Vedova has emphasised the need for preventing pharmaceutical companies from consolidating monopolies. “Rampant consolidation in the pharmaceutical industry has given powerful companies a pass to exorbitantly hike prescription drug prices, deny patients access to more affordable generics, and hamstring innovation in life-saving markets,” Bloomberg quoted Vedova as saying. Amgen, however, has countered FTC's allegations, stating that the claim of a potential 'multiproduct discount' was speculative and did not align with the competitive dynamics of the real world, a Bloomberg report noted. Horizon Therapeutics has also issued a statement, denying claims made by the US trade regulator. 'Multiproduct discount' is a monopolistic practice often frowned upon by the market. While it gives multiple products in one bundle at cheaper rates, this practice often forces smaller competitors to exit the market in the long run. FTC vs. Big Pharma This lawsuit marks the first time since 2009 that the FTC has taken legal action to prevent a pharmaceutical merger. In the past, the agency typically allowed mergers to proceed on the condition that the companies divested any overlapping treatments. However, under the leadership of Lina Khan, the US trade regulator has adopted a more stringent approach, challenging high-profile deals such as Microsoft Corp.'s proposed acquisition of Activision Blizzard Inc. and Intercontinental Exchange Inc.'s purchase of Black Knight Inc, a mortgage software rival. Amgen, a prominent player in the pharmaceutical industry with 27 approved drugs, including popular treatments for rheumatoid arthritis and psoriasis, now faces scrutiny over its acquisition strategy. On the other hand, Horizon Therapeutics distributes 11 drug products in the US, including Tepezza, which is used to treat thyroid eye disease, and Krystexxa, a medication for chronic refractory gout. These medications currently enjoy a lack of competition in the market, generating significant revenue for Horizon in 2022 — $1.97 billion for Tepezza and $716 million for Krystexxa, as reported in company filings. Under the Biden administration, the regulator has closely examined mergers, conduct, and pricing practices within the hospital, physician practice, pharmaceutical, and medical device sectors. Its scrutiny has resulted in five hospitals abandoning their merger plans in the past two years. Additionally, the FTC has launched investigations into pharmaceutical benefit managers like Cigna Group's Express Scripts and CVS Health Corp.'s Caremark to explore their potential role in driving up drug prices. (With agency inputs)

US trade regulator wants to block Amgen's $28 billion deal on hold. Here's why

The global rise of superbugs poses a threat to humankind, reveals a new report by the UN Environment Programme (UNEP). Pollution caused by animal farming and pharmaceutical companies has exacerbated the rise of superbugs which could kill tens of millions by mid-century.

The global rise of superbugs poses a threat to humankind, reveals a new report by the UN Environment Programme (UNEP). Pollution caused by animal farming and pharmaceutical companies has exacerbated the rise of superbugs which could kill tens of millions by mid-century. The report, published on Tuesday, asserted that pollution and lack of sanitation, which often leads to the growth of superbugs in developing nations cannot be seen as a localised problem. The superbugs spread across quickly, not differentiating between rich, poor or developing, developed nations. Well-funded healthcare systems can be brought to their knees as they would not have the means to tackle the superbugs. What are superbugs? In layman's terms, superbugs are strains of bacteria, viruses, fungi or parasites that are resistant to most antibiotic medicines. The disinfectants, antiseptics and antibiotics that can help microbes become stronger are everywhere, from toothpaste and shampoo to cow's milk and wastewater. They become Antimicrobial Resistant (AMR), primarily through two means. One is the excessive use of medicines in animal farming which provides the bacterial strains with the opportunity to mutate and avoid the effects of any antibiotic. Secondly, pharma companies polluting the waterways. The drug companies do not treat the medical sewage adequately which creates resistant superbugs. Read more: Poo transplants to help patients struggling with superbugs Antimicrobial resistance (AMR) is a natural phenomenon. However, the overuse of medicines, especially antibiotics has exacerbated the process. The cost the superbugs entail The report added that as many as 10 million people could be dying every year by 2050 due to AMR — making it as big a killer as cancer is today. Not only will the rise of superbugs exact a human life toll, but it will also adversely affect global economics. The report suggests that the direct economic consequence of AMR would be approximately $3.4 trillion a year by the end of 2030. Additionally, 24 million people could be pushed into extreme poverty. “Pollution of air, soil and waterways undermines the human right to a clean and healthy environment. The same drivers that cause environmental degradation are worsening the antimicrobial resistance problem. The impacts of anti-microbial resistance could destroy our health and food systems," read the report. Read more: New antibiotics could save millions from drug-resistant superbugs It is a silent pandemic and the increasingly bulletproof superbug could very well emerge as the biggest threat to mankind in the not-so-distant future. (With inputs from agencies) WATCH WION LIVE HERE:

Superbugs could be as big a killer as cancer is today by 2050: UN report

China will toughen law enforcement to curb monopoly practices and unfair competition this time in its pharma industry, the action follows November's regulatory guidelines that were to stamp out monopoly's inactive pharma ingredients.

China's crackdown on Pharma industry

The new US position in support of lifting&nbsp;patents&nbsp;on&nbsp;Covid-19&nbsp;vaccines&nbsp;has&nbsp;taken attention away from an equally significant change by Washington, which plans to open up trade in the raw materials used to make them.

After&nbsp;having recently taken heat for blocking such exports, Commerce Secretary Katherine Tai said Wednesday that the US government would "work to increase the raw materials needed to produce those&nbsp;vaccines".

The assertion was hidden at the bottom of the statement unveiling Washington's remarkable reversal of its position&nbsp;on&nbsp;Covid-19&nbsp;vaccine&nbsp;patents, which coincides with a shortage of doses in emerging and developing nations as cases surge in some countries.

Also read |&nbsp;<a href="https://www.wionews.com/world/us-backs-india-led-fight-to-waive-covid-vaccines-patents-383092">US backs India-led fight to waive Covid vaccines patents</a>

Long legal and economic policy debates likely lie ahead about waiving&nbsp;vaccine&nbsp;patents, particularly at the World Trade Organisation (WTO).

Meanwhile, the difficulties faced by some laboratories in obtaining components to manufacture&nbsp;vaccines&nbsp;look set to stymie the drive to ramp up production.

Two labs have recently spoken out about their difficulties, laying the blame at Washington's door.

Germany's Curevac said it could&nbsp;not secure supplies of certain materials from the United States.

Several days earlier, India's Serum Institute, the world's largest&nbsp;vaccine&nbsp;manufacturer, called&nbsp;on&nbsp;US President Joe Biden to step in.

"Respected @POTUS, if we are to truly unite in beating this virus,&nbsp;on&nbsp;behalf of the&nbsp;vaccine&nbsp;industry outside the US, I humbly request you to lift the embargo of raw material exports out of the US so that&nbsp;vaccine&nbsp;production can ramp up," the company's president Adar Poonawalla wrote&nbsp;on&nbsp;Twitter.

<div class="ui-state-default" contenteditable="false">
<div class="twitter-block" draggable="false">
<blockquote class="twitter-tweet">
Respected <a href="https://twitter.com/POTUS?ref_src=twsrc%5Etfw">@POTUS</a>, if we are to truly unite in beating this virus, on behalf of the vaccine industry outside the U.S., I humbly request you to lift the embargo of raw material exports out of the U.S. so that vaccine production can ramp up. Your administration has the details. 🙏🙏
— Adar Poonawalla (@adarpoonawalla) <a href="https://twitter.com/adarpoonawalla/status/1382978713302683653?ref_src=twsrc%5Etfw">April 16, 2021</a></blockquote>
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There is no actual embargo&nbsp;on&nbsp;exporting&nbsp;vaccine&nbsp;components. Instead, Biden, like his predecessor Donald Trump, invoked the Defense Production Act,&nbsp;which normally concerns wartime,&nbsp;to confront the pandemic.

While it does not explicitly ban exports, it puts the US government first in line to buy certain products made in the country.

US officials have previously played down the possible effect of the law&nbsp;on&nbsp;global&nbsp;vaccine&nbsp;production.

"There's just more global manufacturing happening everywhere in the world than suppliers can currently support,"&nbsp;a US official told a White House briefing late last month&nbsp;on&nbsp;condition of anonymity.

<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/germany-opposes-us-backed-global-waiver-on-protection-for-covid-19-vaccines-383353/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>

Dry ice and sorbitol

Over the past two months, a number of public and private actors have noted the shrinking supply of components needed to manufacture&nbsp;vaccines.

At least 50 components, perhaps as many as 100, go into the jabs.

They include items like the glass vials to ship them, as well as certain types of plastics needed for containers used in the manufacturing process.

Then there are the ingredients themselves.&nbsp;

Curevac is particularly concerned about nucleotides, a building block for the messenger RNA&nbsp;vaccines&nbsp;like the one it is developing.

Also read |&nbsp;<a href="https://www.wionews.com/world/us-germany-rift-on-covid-vaccine-waiver-endangers-fight-against-deadly-virus-383349">US-Germany rift on Covid vaccine waiver endangers fight against deadly virus</a>

The shortage of raw materials is hardly surprising as the pharmaceutical industry expects to double production to 10 billion doses this year.

Richard Hatchett, who heads the Coalition for Epidemic Preparedness Innovations (CEPI), which along with the World Health Organization and Gavi co-runs the Covax&nbsp;vaccine&nbsp;distribution initiative, spoke already in March of seeing "increasing signs of strain within supply chains".

Companies were "beginning to report spot shortages of critical materials, raw materials, critical consumables, even equipment that is necessary for&nbsp;vaccine&nbsp;manufacturing," he said.

He was speaking at a meeting of the principal actors in the sector, including WHO and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).

Already the consensus was that the free circulation of&nbsp;vaccine&nbsp;components was critical, given that a large number of countries are involved in their production.

OECD data from 2018 show how thoroughly&nbsp;component&nbsp;production is intertwined across the globe.

China dominates production of the glass storage vials, while the United States leads in the manufacturing of syringes.

France is a major producer of certain stabilisers like sorbitol, while Germany is big in the production of&nbsp;vaccine&nbsp;preservatives, and Mexico and China both are important manufacturers of additives that enhance the effects of&nbsp;vaccines.

Meanwhile, the Netherlands is a leader in the production of dry ice used to transport&nbsp;vaccines&nbsp;that need to be kept at ultra-low temperatures.

The new US position in support of lifting patents on Covid-19 vaccines has taken attention away from an equally significant change by Washington, which plans to open up trade in the raw materials used to make them.

The new US position in support of lifting patents on Covid-19 vaccines has taken attention away from an equally significant change by Washington, which plans to open up trade in the raw materials used to make them. After having recently taken heat for blocking such exports, Commerce Secretary Katherine Tai said Wednesday that the US government would "work to increase the raw materials needed to produce those vaccines". The assertion was hidden at the bottom of the statement unveiling Washington's remarkable reversal of its position on Covid-19 vaccine patents, which coincides with a shortage of doses in emerging and developing nations as cases surge in some countries. Also read | US backs India-led fight to waive Covid vaccines patents Long legal and economic policy debates likely lie ahead about waiving vaccine patents, particularly at the World Trade Organisation (WTO). Meanwhile, the difficulties faced by some laboratories in obtaining components to manufacture vaccines look set to stymie the drive to ramp up production. Two labs have recently spoken out about their difficulties, laying the blame at Washington's door. Germany's Curevac said it could not secure supplies of certain materials from the United States. Several days earlier, India's Serum Institute, the world's largest vaccine manufacturer, called on US President Joe Biden to step in. "Respected @POTUS, if we are to truly unite in beating this virus, on behalf of the vaccine industry outside the US, I humbly request you to lift the embargo of raw material exports out of the US so that vaccine production can ramp up," the company's president Adar Poonawalla wrote on Twitter. Respected @POTUS, if we are to truly unite in beating this virus, on behalf of the vaccine industry outside the U.S., I humbly request you to lift the embargo of raw material exports out of the U.S. so that vaccine production can ramp up. Your administration has the details. 🙏🙏 — Adar Poonawalla (@adarpoonawalla) April 16, 2021 × There is no actual embargo on exporting vaccine components. Instead, Biden, like his predecessor Donald Trump, invoked the Defense Production Act, which normally concerns wartime, to confront the pandemic. While it does not explicitly ban exports, it puts the US government first in line to buy certain products made in the country. US officials have previously played down the possible effect of the law on global vaccine production. "There's just more global manufacturing happening everywhere in the world than suppliers can currently support," a US official told a White House briefing late last month on condition of anonymity. Dry ice and sorbitol Over the past two months, a number of public and private actors have noted the shrinking supply of components needed to manufacture vaccines. At least 50 components, perhaps as many as 100, go into the jabs. They include items like the glass vials to ship them, as well as certain types of plastics needed for containers used in the manufacturing process. Then there are the ingredients themselves. Curevac is particularly concerned about nucleotides, a building block for the messenger RNA vaccines like the one it is developing. Also read | US-Germany rift on Covid vaccine waiver endangers fight against deadly virus The shortage of raw materials is hardly surprising as the pharmaceutical industry expects to double production to 10 billion doses this year. Richard Hatchett, who heads the Coalition for Epidemic Preparedness Innovations (CEPI), which along with the World Health Organization and Gavi co-runs the Covax vaccine distribution initiative, spoke already in March of seeing "increasing signs of strain within supply chains". Companies were "beginning to report spot shortages of critical materials, raw materials, critical consumables, even equipment that is necessary for vaccine manufacturing," he said. He was speaking at a meeting of the principal actors in the sector, including WHO and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Already the consensus was that the free circulation of vaccine components was critical, given that a large number of countries are involved in their production. OECD data from 2018 show how thoroughly component production is intertwined across the globe. China dominates production of the glass storage vials, while the United States leads in the manufacturing of syringes. France is a major producer of certain stabilisers like sorbitol, while Germany is big in the production of vaccine preservatives, and Mexico and China both are important manufacturers of additives that enhance the effects of vaccines. Meanwhile, the Netherlands is a leader in the production of dry ice used to transport vaccines that need to be kept at ultra-low temperatures.

After shift on vaccine patents, US backs freer flow of components

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