News & Insights

In advance of a Senate hearing on health care costs, the NAM is ensuring that senators understand the importance of biopharmaceutical innovation to patients and the U.S. economy—and the damaging impact of policies that hinder drug development.

What’s happening: The Senate Armed Services Committee will hold a subcommittee hearing today on whether harmful policies like price controls, compulsory licensing and weaker intellectual property protections for new medicines could reduce servicemembers’ health care costs.

NAM pushes back: The NAM is highlighting the extraordinary investment—in both time and capital—that it takes to bring a lifesaving treatment to market. According to the NAM:

• The average cost of developing a new drug was $2.3 billion as of 2022;
• Across the industry, biopharmaceutical manufacturers spent $139 billion on R&D in just 2022 alone;
• It can take 10 to 15 years for a breakthrough scientific discovery to move through early-stage research, clinical trials, Food and Drug Administration approval and manufacturing; and
• Only 12% of investigational drugs that enter a Phase I clinical trial ultimately receive FDA approval—to say nothing of the hundreds of discoveries that never make it into clinical trials.

Lifesaving impact: In 2023, the FDA approved a record-breaking 71 new medicines that will improve the lives of patients.

• The biopharmaceutical industry behind these breakthroughs is also stimulating the U.S. economy: Biopharmaceutical manufacturers accounted for $355 billion in value-added output to the U.S. economy in 2021 and directly employed 291,000 workers in the U.S.

Innovation under threat: In recent years, biopharmaceutical manufacturers have been subject to harmful policies that will limit innovation and slow efforts to develop lifesaving medicines.

• The Medicare Drug Price Negotiation Program subjects life-changing biopharmaceutical innovations to government price controls, while the Biden administration’s “march-in” proposal undermines innovators’ IP rights. These policies make it riskier and more costly for manufacturers to invest in groundbreaking research.
• What’s more, the prices Americans pay for medicines are influenced heavily by middlemen, such as pharmacy benefit managers rather than biopharma companies. In 2020, more than half of every dollar spent on brand medicines went to PBMs and others in the health care system—not the medicine’s manufacturer.

The final word: “The costs of manufacturing a medicine include potentially decades of research and billions of dollars of investment,” said NAM Vice President of Domestic Policy Charles Crain. “Congress must avoid adopting policies that will stymie this lifesaving innovation.”

Washington, D.C. – Following the release of the Environmental Protection Agency’s new regulations on greenhouse gas emissions standards for certain power plants, National Association of Manufacturers President and CEO Jay Timmons released the following statement:

“Manufacturers appreciate the EPA removing existing gas plants from its new regulation, following manufacturers’ warnings about the initial proposal. However, the rest of the rule causes serious concern because Congress and the president have not enacted permitting reform—making it impossible to achieve the EPA’s highly aspirational mandates. We call on Congress to get serious by enacting significant and meaningful permitting reform this year. That is essential to ramping up the use of renewables, carbon capture, hydrogen and nuclear, for example, to meet future demand.

“The final rule threatens grid reliability because of the unrealistic timeline for power plants to adopt technologies within the next 10 years that have yet to even be proven at scale. Our nation should be doing everything possible to make sure our families, businesses and manufacturers have a modern, strong and reliable electrical grid, especially at a time when global turmoil threatens our energy security. This new rule does the opposite, creating a threat to our national and economic security that literally could leave Americans in the dark and factories offline. In short, the EPA is rolling the dice with Americans’ electricity and therefore with President Biden’s manufacturing legacy.

“Our industry has made transformational investments in these technologies and clean energy solutions, and we are leading the way in their deployment. The EPA should be partnering with us—not undermining this progress. We will continue to press the administration to achieve a more balanced regulatory framework to help reach our climate goals.”

-NAM-

The National Association of Manufacturers is the largest manufacturing association in the United States, representing small and large manufacturers in every industrial sector and in all 50 states. Manufacturing employs nearly 13 million men and women, contributes $2.89 trillion to the U.S. economy annually and accounts for 53% of private-sector research and development. The NAM is the powerful voice of the manufacturing community and the leading advocate for a policy agenda that helps manufacturers compete in the global economy and create jobs across the United States. For more information about the NAM or to follow us on Twitter and Facebook, please visit www.nam.org.

The Federal Trade Commission’s vote this week to prohibit noncompete agreements between employers and their employees threatens manufacturing in the U.S., the NAM said Tuesday.

What’s going on: In a 3–2 vote Tuesday, commissioners finalized a rule that, like a draft version circulated last year, “would deem practically any noncompete clauses for paid staff, independent contractors and unpaid workers to be an unfair method of competition rendered unenforceable, and [would require] employers to tell current and former employees they’ve stopped enforcing them” (Law360, subscription).

• The final rule is set to go into effect 120 days after it is published in the Federal Register, but lawsuits have been filed against it already, and additional legal action is expected.

What’s changed: One change made to the final rule following the receipt of more than 26,000 comments on it allows existing noncompete agreements with senior-level executives to remain in effect.

• Another difference between the rule’s prior iteration and the final is to the ban’s sole exception. The draft “permitted noncompetes for individuals selling their business or a substantial stake of at least 25%.” That threshold is not in the final version.

Why it’s problematic: The rule “is unprecedented and threatens manufacturers’ ability to attract and retain talent,” said NAM Managing Vice President of Policy Chris Netram.

• “In addition, [it] puts at risk the security of intellectual property and trade secrets—anathema to an industry that accounts for 53% of all private-sector R&D.”
• A noncompete ban would disrupt the majority of U.S. manufacturing operations, a 2023 NAM survey found.

What’s next: The NAM is considering all options in response to the final rule and is in active discussion with congressional leadership and the relevant committees of jurisdiction.

A new final overtime rule from the U.S. Department of Labor will reduce flexibility for employees and could force manufacturers to make difficult choices about their workforces, the NAM said Tuesday.

What’s going on: The new regulation “changes the salary threshold used to determine whether a worker is exempt from overtime pay” so that, beginning Jan. 1, 2025, most employees earning less than $58,656 will be owed time-and-a-half wages for hours worked over 40 in a single workweek (Bloomberg Law, subscription).

• The current salary threshold is $35,568.
• The new rule will go into effect July 1, following publication in the Federal Register.

Why it’s problematic: The change promises to present significant challenges to employers and employees alike.

• “Quarter after quarter, manufacturers cite workforce issues, such as attracting and retaining skilled employees, as their biggest business challenge,” said NAM Managing Vice President of Policy Chris Netram. The “rule places new constraints on employers, reduces flexibility for the workers who will be reclassified and may force companies to make painful choices that limit both job creation and growth opportunities available to employees.”

What’s next: The NAM is weighing all actions to protect manufacturers across the country.
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As government regulation of per- and polyfluoroalkyl substances ramps up worldwide, Thermo Fisher Scientific is seeing a boom in its PFAS testing business.

“We’ve seen an increase in demand from a number of countries in the Americas and in Europe,” said Toby Astill, director of environmental and food safety in chromatography and mass spectrometry at the life sciences giant. “Those regions are driving more discussions around current and future regulations than other regions.”

• In recent weeks, the Environmental Protection Agency has issued several final rules concerning PFAS. These include the first-ever national regulation limiting PFAS in drinking water to near-zero levels and, just last week, the designation of two PFAS chemicals as hazardous substances under the Superfund law.

Writing is on the wall: Thermo Fisher foresaw the need for comprehensive PFAS analysis early on. That’s why it’s been offering clients a full suite of testing capabilities for more than a decade.

• Commonly called “forever chemicals” because they do not break down easily in the environment, PFAS were used widely in everyday products starting in the 1940s, owing to their ability to put out fires and resist grease, corrosion and stains in addition to countless other consumer and industrial applications.
• Using chromatography—“technology that allows lab users to separate and analyze the different components in samples,” according to Astill—Thermo Fisher can “confirm the presence of a specific substance and determine how much is there.”
• The tech is not limited to PFAS, however; it can also detect, down to parts per trillion, the presence of pesticides, heavy metals and other substances, Astill said. And it works on samples of almost anything, including food packaging, water and even air.

Aiding compliance: In coming years, manufacturers may need to analyze their PFAS exposure comprehensively to remain compliant with Toxic Substances Control Act and other international regulations, including those from the EPA, Astill said.

• In 2021, the EPA released its PFAS Strategic Roadmap, addressing the entire lifecycle of PFAS.
• Early last year, the agency proposed the first federal limits on PFAS, instituting maximum allowable levels for six substances in drinking water.
• In January, it finalized an “inactive PFAS” rule, mandating that any company wishing to manufacture or import PFAS chemicals that haven’t been made in years must first get approval from the EPA.
• That’s where testing comes in. “Manufacturers will want to figure out their [level of] PFAS exposure—whether it’s from their supply chains or the products they’re making,” Astill went on. “Because we see an evolving regulatory landscape, manufacturers need to have a baseline of where they are today, in 2024. That way they’re more prepared for regulatory compliance, and if needed, can review data retrospectively to understand trends. In fact, in October 2023, the EPA issued a mandatory one-time reporting rule on most PFAS manufactured or imported into the U.S. since 2011.”
• This February, the EPA proposed two regulations under the Resource Conservation and Recovery Act that added nine PFAS to the list of RCRA hazardous constituents with superfund implications. 

Smart legislation: Thermo Fisher recognizes that we still have much to learn about PFAS chemicals, including whether many of them are harmful in the first place and whether there are practicable alternatives. In light of the many unknowns, the company recommends that legislators take a judicious approach to their regulation.

• “We don’t yet know everything about PFAS or all the PFAS” in existence, said Astill. “We need longer-term studies so we understand what we need to regulate and what we need to measure—be it in manufacturing materials or water—before we start regulating more.”
• Forthcoming regulations should also take into account the difficulty and expense of implementing PFAS remediation solutions, she added. “Legislators and regulators should consider the fact that this is not an easy feat for companies.”

Working on an alternative: While Thermo Fisher is not involved directly in inventing alternatives to PFAS, it is working actively with organizations that are doing just that, and it’s optimistic about the outcomes.

• “It’s [been] very difficult to find something with equal properties that is less of a potential health and environmental issue,” Astill said. “But what we have is a lot of intelligent global groups collaborating to share testing data and understand what potential replacement materials make sense—and that’s a tremendous opportunity.”

Washington, D.C. – Following the Federal Trade Commission’s vote in favor of a rule that would prohibit employers and their employees from entering noncompete agreements, National Association of Manufacturers Managing Vice President of Policy Chris Netram released the following statement:

“The FTC’s rule banning noncompete agreements is unprecedented and threatens manufacturers’ ability to attract and retain talent. In addition, today’s action puts at risk the security of intellectual property and trade secrets—anathema to an industry that accounts for 53% of all private-sector R&D.

“An NAM survey found that 66% of respondents—manufacturers of all sizes—said the ban would interfere with their operations, and nearly half said it would impact employee training programs. The ban could force manufacturers to revamp their human capital operations completely, enact burdensome controls or silo parts of their operations from each other, which would result in less training for employees, less collaboration, less innovation and less efficiency. The NAM will weigh all options in response to the commission’s vote, so that well-paying manufacturing jobs and innovation are not compromised.”

-NAM-

The National Association of Manufacturers is the largest manufacturing association in the United States, representing small and large manufacturers in every industrial sector and in all 50 states. Manufacturing employs nearly 13 million men and women, contributes $2.89 trillion to the U.S. economy annually and accounts for 53% of private-sector research and development. The NAM is the powerful voice of the manufacturing community and the leading advocate for a policy agenda that helps manufacturers compete in the global economy and create jobs across the United States. For more information about the NAM or to follow us on Twitter and Facebook, please visit www.nam.org.

Washington, D.C. – Following the release of the Department of Labor’s Wage and Hour Division rule concerning updates to the overtime regulations, National Association of Manufacturers Managing Vice President of Policy Chris Netram released the following statement:

“Quarter after quarter, manufacturers cite workforce issues, such as attracting and retaining skilled employees, as their biggest business challenge. Yet today’s rule places new constraints on employers, reduces flexibility for the workers who will be reclassified and may force companies to make painful choices that limit both job creation and growth opportunities available to employees. In addition, this latest regulatory hurdle will complicate manufacturers’ efforts to fill the millions of jobs our industry is projected to create within a decade.”

-NAM-

The National Association of Manufacturers is the largest manufacturing association in the United States, representing small and large manufacturers in every industrial sector and in all 50 states. Manufacturing employs nearly 13 million men and women, contributes $2.89 trillion to the U.S. economy annually and accounts for 53% of private-sector research and development. The NAM is the powerful voice of the manufacturing community and the leading advocate for a policy agenda that helps manufacturers compete in the global economy and create jobs across the United States. For more information about the NAM or to follow us on Twitter and Facebook, please visit www.nam.org.

The NAM testified before the U.S. Copyright Office last week, explaining how two proposed exemptions from copyright protections would weaken manufacturers’ intellectual property rights, do significant harm to their businesses and potentially endanger consumers.

What’s going on: The Copyright Office is considering whether to recommend two exemptions from the Digital Millennium Copyright Act that would allow users to circumvent measures protecting copyrighted content.

• One proposal was designed to allow the so-called “right-to-repair” by enabling access to operational data (including diagnostic and telematics data) from automobiles, agricultural vehicles, marine vessels and more. The other is focused on industrial equipment.

NAM speaks out: “The basis of the so-called ‘right-to-repair’ movement hinges on the false notion that owners do not have the ability to repair their own equipment,” NAM Vice President of Domestic Policy Charles Crain said at the recent hearing. “The truth, however, is that the majority of [original equipment manufacturers] already provide a wide range of resources and tools that allow users—and third-party repair businesses—to maintain, diagnose and repair products.”

• The NAM previously submitted comments urging the Copyright Office not to adopt the proposed exemptions.

Why it’s important: “These exemptions would undermine manufacturers’ IP rights in service of right-to-repair—and the record does not support their adoption,” Crain continued.

• The exemptions are too broad and inadequately defined, and their proponents have “failed to show that users will be adversely affected absent the ability to circumvent [copyright law].”
• What’s more, the exemptions “would expose proprietary information to public consumption and use, likely endangering consumers and allowing for unlawful modifications of government-mandated safety and emissions limits.”

The last word: “In short, right-to-repair is a solution in search of a problem,” Crain said.

Washington, D.C. – Following the House vote on the national security supplemental package, NAM President and CEO Jay Timmons released the following statement:

“Today’s bipartisan vote sends a powerful message that our nation is committed to standing strong in defense of democracy. Manufacturers thank Speaker Johnson for his leadership in shepherding these bills through the House at a critical juncture for our national security and for global stability.

“In March of 2022 at the onset of the Russian invasion, the NAM Board of Directors unanimously passed a resolution, ‘stand[ing] with the people of Ukraine in their fight to preserve freedom and independence.’ Last year, Ukrainian President Volodymyr Zelenskyy spoke to the NAM Board of Directors in an address to the American business community, and he underscored that ‘democracy is stronger than tyranny.’ Manufacturers share that conviction and will support those in Congress who recognize the importance of standing firm for our shared values.”

-NAM-

The National Association of Manufacturers is the largest manufacturing association in the United States, representing small and large manufacturers in every industrial sector and in all 50 states. Manufacturing employs nearly 13 million men and women, contributes $2.89 trillion to the U.S. economy annually and accounts for 53% of private-sector research and development. The NAM is the powerful voice of the manufacturing community and the leading advocate for a policy agenda that helps manufacturers compete in the global economy and create jobs across the United States. For more information about the NAM or to follow us on Twitter and Facebook, please visit www.nam.org.

Washington, D.C. – Following the release of the Environmental Protection Agency’s rule designating perfluorooctane sulfonic acid, also known as PFOS, and perfluorooctanoic acid, also known as PFOA, as hazardous substances under the Comprehensive Environmental Response, Compensation and Liability Act, National Association of Manufacturers Managing Vice President of Policy Chris Netram released the following statement:

“Manufacturers support efforts to mitigate harmful chemicals from impacting our environment and the health of our nation, but this unprecedented use of CERCLA authority by the EPA will only hamper President Biden’s vision of growing the manufacturing sector in the U.S. The unique and unmatched chemical bond of these compounds means that there are no existing replacements for the critical products they make up.

“The NAM is not opposed to commonsense regulations of PFAS chemicals, and manufacturers are committed to environmental stewardship, while recognizing in many cases we will need to continue to use these chemicals for the foreseeable future. However, designating these compounds as hazardous substances is a blunt, overreaching decision that will make it harder for our industry to create innovative products and jobs.”

-NAM-

The National Association of Manufacturers is the largest manufacturing association in the United States, representing small and large manufacturers in every industrial sector and in all 50 states. Manufacturing employs nearly 13 million men and women, contributes $2.89 trillion to the U.S. economy annually and accounts for 53% of private-sector research and development. The NAM is the powerful voice of the manufacturing community and the leading advocate for a policy agenda that helps manufacturers compete in the global economy and create jobs across the United States. For more information about the NAM or to follow us on Twitter and Facebook, please visit www.nam.org.