Health Care

Medical supply chains are critical to ensuring the health and security of Americans—and Congress should act to bolster their resiliency, the NAM told members of Congress this month.

What’s going on: “The COVID-19 pandemic brought to light the risks and instability resulting from concentration and choke points in medical supply chains, though the pandemic also showed how medical supply chains can quickly adjust to external shocks,” NAM Managing Vice President of Policy Chris Netram told Reps. Brad Wenstrup (R-OH), Blake Moore (R-UT) and August Pfluger (R-TX) in response to a request for information on how to improve medical supply chains.

What should be done: The NAM recommended that Congress should work with manufacturers “on a comprehensive approach to find ways to onshore, near-shore and friend-shore more of the medical supply chain,” Netram continued.

There are several actions the federal government should take to fortify medical supply chains, including:

• “[C]reating an environment where small businesses can continue to thrive” and where large companies can maintain their pandemic-era practices of “leveraging sources of domestic production when feasible, working with existing smaller suppliers to improve their reliability” and sourcing goods through new suppliers;
• Streamlining the Food and Drug Administration’s new-supplier certification process;
• Taking “creative steps to incentivize onshoring, near-shoring and friend-shoring, as opposed to imposing punitive or unworkable requirements to do so”;
• Passing the Medical Supply Chain Resiliency Act (H.R. 4307/S. 2115), which would authorize the president to strategically create new trade agreements specific to medical goods with our allies and partners;
• Strategically refining Section 301 tariffs on imports from China;
• Restoring “immediate research and development expensing and full expensing of capital equipment purchases,” ensuring “that the corporate tax rate does not exceed 21%” and making the pass-through deduction permanent; and
• Completing “reauthorization of the Workforce Innovation and Opportunity Act and expansion of Pell grant eligibility to short-term training programs,” as well as supporting solutions that incentivize companies to collaborate to reduce the manufacturing-worker shortage.

The bottom line: “[A]n approach that creates incentives that reduce the cost and complexity of moving supply chains can help U.S. manufacturers to be more resilient in the face of a future global crisis and better able to serve patients who depend on these products,” Netram said.

Drug price controls will “chill” critical innovation in pharmaceutical manufacturing and do nothing to address the underlying causes of high medication costs, Johnson & Johnson leaders said recently.

What’s going on: J&J Chairman and CEO Joaquin Duato and Executive Vice President and Chief Financial Officer Joseph Wolk told Bloomberg TV earlier this month that the pharmaceutical price controls mandated by the 2022 Inflation Reduction Act do a disservice to patients everywhere.

• “[T]he Inflation Reduction Act … is something that is misguided, and it’s going to chill innovation,” Duato told Bloomberg’s David Gura earlier this month. “When you chill innovation on investment in [research and development], then you have [fewer] cures.”
• The IRA gave the federal government authority to set prices for certain prescription medications in Medicare. In August, the Biden administration released the first 10 Medicare prescription drugs subject to those price controls, which go into effect in 2026.
• “I’d like to see a much more fact-based dialogue around the topic of drug pricing,” Wolk added. “About six years ago, Johnson & Johnson … was paying about 25% in discounts and rebates off [the] list price [of medications]. Today, that [figure is] 60%, yet the patients aren’t receiving the benefit of those discounts.”

The background: Pharmacy benefit managers are supposed to pass the manufacturer discounts they receive on to health plans and patients—but instead, they frequently pocket the discounts, the NAM has told Congress on several occasions.

• That’s one of several problematic business practices Congress must end by enacting comprehensive PBM reform, the NAM has said.
• Such legislation would do far more to benefit consumers than capping drug prices.

Cause and effect: The result of price controls will be fewer breakthrough cures and treatments for patients suffering from various illnesses, J&J told Bloomberg TV.

• “The number of medicines that will be there will be [lower], just because [fewer] investors would be putting money into developing new medicines,” Duato continued. “It’s going to be less attractive for investors to put money there.”
• And as Wolk said in another Bloomberg segment: “Investing in R&D, prioritizing R&D years in advance for [a drug] that may happen 10 years down the road is critically important.”

What should be done: If Congress truly wants to help patients with the cost of medications, it must focus on “the middlemen who are really driving up prices: pharmacy benefit managers,” NAM President and CEO Jay Timmons said recently.

The NAM this week advocated the passage of two pieces of manufacturing-critical legislation, successfully driving the agenda of a Wednesday House Energy and Commerce Committee markup.

What’s going on: The committee—with the NAM’s strong support—approved two bills that address longstanding manufacturing priorities:

• A congressional resolution disapproving of the Environmental Protection Agency’s harmful PM2.5 rule
• A bill instituting important pharmacy benefit manager reforms

Reversing an unworkable PM2.5 standard: The EPA announced a new, more restrictive particulate matter standard in February, reducing allowable levels from 12 micrograms per cubic meter of air to 9 micrograms—despite a standard of 9 being “essentially background levels in some of the country,” as the NAM has pointed out.

• “Manufacturers have sharply reduced particulate matter emissions, or PM2.5; as a result, industry in the United States has some of the cleanest and most efficient operations in the world,” NAM Vice President of Domestic Policy Chris Phalen told the committee.
• “Now, the vast majority of emissions are from sources well outside of our control, with fires, dirt roads and other nonpoint sources accounting for 84% of PM2.5 emissions,” Phalen continued. “[T]he EPA’s rule will make it more difficult for states to issue permits for the construction of new facilities or expansions of existing factories.”
• The committee’s PM2.5 resolution, offered under the Congressional Review Act, seeks to overturn the EPA’s unworkable standard.

Reforming PBMs: PBMs are unregulated middlemen whose business practices drive up health care costs for manufacturers and manufacturing workers.

• “By applying upward pressure to list prices that dictate what patients pay at the pharmacy counter, pocketing manufacturer rebates and failing to provide an appropriate level of transparency about their business practices, PBMs increase health care costs at the expense of all patients in America,” NAM Vice President of Domestic Policy Charles Crain said.
• Provisions in the NAM-supported Telehealth Modernization Act would increase transparency into PBMs’ business practices and delink their compensation from medicines’ list prices.

The last word: “Manufacturers commend the Energy and Commerce Committee for approving these important bills, which will reduce costs and enhance growth at manufacturers across the country—allowing our industry to continue to create jobs here at home and drive U.S. competitiveness on the world stage,” said NAM Managing Vice President of Policy Chris Netram.

To lower drug prices, Congress should undertake comprehensive reform of pharmacy benefit managers, not embrace price controls, the NAM told the Senate Tuesday.

What’s going on: “Biopharmaceutical manufacturers are a critical part of the manufacturing economy,” NAM Vice President of Domestic Policy Charles Crain said ahead of a Senate Finance Committee hearing on health care costs.

• In 2021, biopharmaceutical firms “accounted for $355 billion in value-added output to the U.S. economy … and directly employed 291,000 workers in the United States, with each of these jobs supporting an additional 4.1 jobs.”
• Crucially, biopharma companies are also responsible for the dozens of groundbreaking, lifesaving medications brought to patients annually.
• But their continued innovation and economic impact are under attack by both Inflation Reduction Act–mandated drug price controls and the largely unchecked actions of PBMs, Crain continued.

Threats to innovation: Instead of benefiting patients, “the IRA pricing mandates announced last month by the Department of Health and Human Services will … limit the capital manufacturers have available to put toward the astronomically high costs of developing a new medicine,” Crain told the committee, adding that the uncertainty introduced by price controls is also likely to dissuade early-stage investment in new treatments.

• Rather than impose further price controls, Congress should address the influence of PBMs, largely unregulated middlemen that “contribute to the skyrocketing cost of health care by applying upward pressure to list prices that dictate what patients pay for medicines at the pharmacy counter, pocketing manufacturer rebates and failing to provide an appropriate level of transparency about their business models.”

PBM reform: To truly lower health care costs, Congress must rein in PBMs, Crain said. The NAM has called on Congress to adopt specific PBM reforms, including:

• Increased transparency into PBMs’ business models;
• Rebate passthrough to ensure that 100% of negotiated savings get passed on to health plan sponsors and employees; and
• Delinking of PBM compensation from medication list prices.

The last word: “Instead of further embracing price controls, it is imperative that Congress act to lower drug prices by reining in PBMs’ problematic business practices and minimizing their ability to further damage the U.S. health care system,” Crain said.

• “All Americans deserve access to high-quality, affordable health care, and PBM reform is an impactful step toward this goal.”

Pharmaceuticals manufacturers are increasingly turning to radioactive drugs in their battle against cancers (CNBC). 

What’s going on: Eli Lily, Bristol Myers Squibb and others “have spent some $10 billion on deals to acquire or work with radiopharmaceuticals makers,” which produce drugs containing radioactive isotopes, predicting that the technology will be effective in treating multiple cancer types.

• Meanwhile, Novartis already has two radiopharmaceuticals, Pluvicto and Lutathera, available for cancer treatment, and several dozen more in development.

How it works: Radiopharmaceutical “drugs work by attaching radioactive material to a targeting molecule that searches for and attaches to a specific marker on cancer cells. The trick is finding markers that exist on cancer cells but not healthy cells. That can allow the treatment to deliver radiation to cancer cells and spare the rest of the body from the level of damage that comes with many cancer drugs.”

• Bristol Myers Squibb sees “opportunity [in] … combining radiopharmaceuticals with existing cancer drugs like immunotherapy, said Robert Plenge, Bristol’s chief research officer.”

More interest: Though radiopharmaceuticals have been around since the 1940s, they’ve only begun drawing big interest in recent years.

• Early this year, Bristol Myers Squibb completed a $4.1 billion acquisition of radiopharmaceutical startup RayzeBio.
• In 2023, Eli Lilly acquired radiopharmaceutical company Point Biopharma and signed partnerships with businesses that are developing treatments.

In-house production: Among the key criteria in Lilly’s search for a firm to acquire: “whether companies were prepared to manufacture the drugs,” according to Eli Lilly Executive Vice President and President of Lilly Oncology Jacob Van Naarden.

• “Radiopharmaceuticals aren’t easy to make, and Lilly wanted to make sure any initial acquisition could produce the drugs themselves instead of outsourcing the work.”

Safety and speed are everything: Each dose of Novartis’ Pluvicto has a GPS tracker to make sure it goes to the correct patient at the correct time, said Victor Bulto, president of the U.S. unit for Novartis. That’s because the therapies are only good for a few days once made.

• Novartis is “investing more than $300 million to open and expand radiopharmaceutical manufacturing sites in the U.S. so it can produce the drug and get it to patients quickly.”
• The pharmaceutical company “drives doses to destinations that are within nine hours from the factory to minimize the risk of disruptions from storms, Bulto said.”

Special considerations: Radiopharmaceuticals come with unique challenges.

• One health care network had to upgrade its medical license before it could be allowed to handle radioactive materials, and “[a] certified specialist needs to administer the drugs, which are given intravenously.”
• To avoid exposing people to radiation, patients taking the treatments must remain at a distance from others for a week or more following the injections, which they get every six weeks.

Big opportunity: Though full understanding of radiopharmaceuticals’ potential may be years away, “[i]f we can be successful in expanding the target and tumor type repertoire, this could be a very big class of medicines,” Van Naarden said.

Rep. Earl L. “Buddy” Carter (R-GA), a staunch advocate for health care reform and a community pharmacist by profession, visited RYAM’s manufacturing facility in Jesup, Georgia, in August to discuss manufacturers’ health care and tax policy priorities.

During the visit, Rep. Carter emphasized the critical need for pharmacy benefit manager reform as well as tax policies that support manufacturers’ growth and competitiveness.

The visit: Clay Bethea, RYAM’s Jesup plant general manager and vice president of U.S. wood procurement, led Rep. Carter on a tour of the cellulose specialties manufacturer’s facility, where he observed how pulp is dried and finished into sheets and rolls. Bethea highlighted the significant challenges the company faces due to rising costs in health care, particularly those driven by PBMs, and the looming expiration of key tax provisions in 2025.

• “We are proud to be a part of this community, creating jobs and driving economic growth,” Bethea said. “However, the rising costs of health care, particularly due to PBMs, and the uncertainty around critical tax provisions like R&D expensing and accelerated depreciation, are growing concerns for both our business and our employees. Reforming PBMs and maintaining tax policies that allow us to invest for the future are crucial to our ability to remain competitive globally.”

PBM reform: Rep. Carter has long been vocal about the need to hold PBMs accountable for their role in inflating health care costs.

• “PBMs have become powerful middlemen, often driving up drug prices while squeezing independent pharmacies out of the market,” Rep. Carter said during the tour. “It’s time for Congress to bring transparency and fairness back to the system.”
• Carter has introduced and supported several pieces of legislation designed to reform PBM practices, including a bill aimed at delinking PBM compensation from drug prices, improving PBM payments to pharmacies and increasing transparency.

Tax challenges: In addition to health care, Rep. Carter addressed the pressing issue of preserving tax reform.

• “The expiration of accelerated depreciation, R&D expensing and favorable tax rates could significantly hamper the manufacturing industry’s ability to grow and remain competitive globally,” Rep. Carter warned.
• “These tax provisions have been crucial for manufacturers like RYAM, enabling them to make significant investments in their operations and workforce. Losing them would not only impact these companies’ ability to innovate but also jeopardize jobs and economic growth in communities across the country.”

NAM in action: The NAM has long advocated for both PBM reform and the preservation of essential tax policies that drive the manufacturing industry.

• “PBMs are a significant driver of the rising costs of health care, and reform is essential to ensure that manufacturers can provide affordable benefits to their workers,” said NAM Vice President of Domestic Policy Charles Crain.
• “Congress also needs to act with urgency to prevent devastating tax increases scheduled for next year that will impact manufacturers across the country.”

The state-level view: Lloyd Avram, president and CEO of the Georgia Association of Manufacturers, echoed Rep. Carter’s concerns.

• “Manufacturers across Georgia are facing unsustainable health care expenses, and the uncertainty surrounding federal tax provisions only adds to the challenges,” Avram said. “Action on PBM reform and tax policy is essential to helping our industry remain competitive and continue providing good jobs in our communities.”

The bottom line: “Reducing health care costs and increasing transparency in the PBM system are crucial steps in lowering the overall cost of doing business in the U.S.,” said Rep. Carter. “However, to truly compete in the global economy, it’s important that we preserve the policies that have empowered manufacturers to innovate, expand and sustain jobs. Otherwise, the U.S. risks becoming a less attractive place for manufacturing investment, ultimately threatening our economic leadership on the world stage.”

Washington, D.C. – Following the release of prices set for the first 10 prescription drugs that were subject to price controls under the Inflation Reduction Act, National Association of Manufacturers President and CEO Jay Timmons released the following statement:

“The pricing mandates released by the Department of Health and Human Services on groundbreaking medicines harm innovation and will slow the development of needed therapies and cures by hampering manufacturers’ ability to pioneer new drugs and treatments. America has led the way in medical and scientific breakthroughs to battle the most devastating and severe illnesses and conditions. There are so many more diseases for which we need to find a cure—like cancer, juvenile diabetes and Alzheimer’s to name just three—and this price control scheme threatens our ability to do so.

“Health care manufacturers in the U.S. invest more than $100 billion annually to create new medicines, putting nearly 17% of their sales right back into R&D. Developing and putting a new drug on the market is a particularly costly and risky endeavor, costing $2.3 billion and taking 15 years, on average. More than 90% of experimental drugs ultimately fail, resulting in billions of dollars of lost investment. But biopharmaceutical manufacturers are committed to finding treatments and cures to devastating diseases like cancer.

“Price controls will limit R&D, plain and simple, as every dollar of revenue curtailed by price controls is a dollar that can’t be devoted toward the astronomically high cost of developing a new medicine.

“This will have an immediate impact on the White House’s manufacturing strategy. Manufacturers are ready to take the lead following President Biden’s announcement Tuesday of $150 million in grants toward his Cancer Moonshot initiative, to prevent more than 4 million cancer-related deaths by 2047, but we’re concerned that goal could be hampered and delayed by the mandates within the IRA.

“There is ultimately a human cost to anything that slows or halts biopharmaceutical manufacturers’ work to develop new treatments or expand production and make those treatments more widely available. Americans’ quality of life will suffer—or they may even lose their lives—because a new treatment was not available in time.

“To truly help Americans, Congress should begin by curtailing the middlemen who are really driving up the prices without giving anything back, such as pharmacy benefit managers. PBMs have severely distorted the cost of pharmaceuticals and lifesaving therapies, driving up the price for patients and employers alike. PBM reform is the way to drive down costs.”

-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.

Middlemen created to manage the price of prescription drugs are instead driving up health care costs for manufacturers and manufacturing workers, the NAM told the House Committee on Oversight and Accountability on Tuesday, the same day the committee released a report on pharmacy benefit managers’ practices and held a hearing on the matter.

What’s going on: “PBMs’ business models have the direct effect of increasing health care costs at the expense of manufacturers and manufacturing workers,” NAM Vice President of Domestic Policy Charles Crain said in advance of the hearing, the latest in a series examining PBM practices.

Crain told lawmakers PBM reform legislation should include:

• “Increased transparency into PBMs’ business models and the many factors that contribute to a drug’s costs, formulary placement and the PBMs’ compensation;
• Rebate passthrough, which will ensure 100% of negotiated pharmaceutical savings are passed from the PBM to the health plan sponsor and workers; and
• Delinking of PBM compensation from the list price of medication.”

Report highlights: The committee’s report, the culmination of a 16-month investigation, is in line with the NAM’s longstanding advocacy. The report found that PBMs:

• Drive increased drug prices, which inflate PBM profits;
• Extract high rebates from biopharmaceutical manufacturers, often pocketing a significant portion of any savings rather than reducing costs for patients;
• Dictate whether and how medicines appear on formularies, which determine insurance companies’ coverage decisions and patients’ out-of-pocket costs;
• Steer patients toward drugs based on PBMs’ profit margins rather than patient costs; and
• Operate without sufficient transparency into their business practices.

What it all means: The committee “identified numerous instances where the federal government, states and private payers have found PBMs to have utilized opaque pricing and utilization schemes to overcharge plans and payers by hundreds of millions of dollars,” the report states.

• The report indicates that the present role of PBMs in prescription drug markets is failing and requires change, something the NAM has long advocated. “Congress and states must implement legislative reforms to increase the transparency of the PBM market and ensure patients are placed at the center of our health care system, rather than PBMs’ profits.”

The last word: “Manufacturers provide health care benefits so they can effectively attract and retain employees, to maintain a healthy and productive workforce and because they believe it is the right thing to do—but PBMs are a meaningful cause of the skyrocketing costs of health care,” Crain said.

• “Congress must enact reforms to the PBM system so that employers can negotiate, compete and achieve health care savings for their workers.”

Although they were created to keep prescription drug prices down, pharmacy benefit managers “frequently do the opposite” (The New York Times, subscription)—and that’s one of the main reasons the NAM has long advocated for their reform.

What’s going on: “The job of the P.B.M.s is to reduce drug costs. Instead, they …
steer patients toward pricier drugs, charge steep markups on what would otherwise be inexpensive medicines and extract billions of dollars in hidden fees, a New York Times investigation found.”

Why it’s important: PBMs frequently charge employers and government programs, such as Medicare, many times the wholesale cost of a medication and keep the difference, according to the Times.

• And it’s not just those taking prescriptions who pay; when drug costs are inflated, everyone ends up paying higher insurance premiums.
• What’s more, “[b]ecause of recent mergers, [the big three PBMs] are becoming more dominant, collectively processing roughly 80 percent of prescriptions in the United States.” That’s up more than 30% from just 12 years ago.

Working around a workaround: In 2018, in response to growing pressure from employers to get PBMs to share more of the discounts from drug manufacturers, PBMs set up entities known as group purchasing organizations.

• These GPOs pass savings to employers—but they “also began imposing new fees on drug manufacturers,” money they were not contractually bound to pass on to clients.
• The result: “Employers are none the wiser. They receive rebates. But they can’t see the billions of dollars in fees that the G.P.O.s take for themselves.”

Congress makes moves: Since the beginning of last year, seven House and Senate committees have passed PBM-reform legislation, including policies to increase transparency into PBMs’ business practices, delink PBM compensation from medications’ list prices and ensure that rebates are fully passed through to the plan sponsor or patient.

• The NAM has been crucial in educating lawmakers on the need for these reforms and continues to advocate for PBM reform to be signed into law this year.

The last word: “PBMs drive up health care costs for manufacturers and manufacturing workers,” said NAM Vice President of Domestic Policy Charles Crain. “Congress must act as soon as possible to enact comprehensive PBM reform that benefits employers by making PBM contracts more straightforward, transparent and predictable—and benefits workers by reducing the prices they pay out of pocket for their prescriptions.”

Washington, D.C. – Following the House Ways and Means Committee’s unanimous approval of legislation to reform pharmacy benefit managers—middlemen who unfairly increase the prices that patients pay at the pharmacy counter by controlling negotiations between insurers and biopharmaceutical manufacturers—in Medicare markets, National Association of Manufacturers President and CEO Jay Timmons released the following statement:

“The NAM commends the Ways and Means Committee for unanimously taking a powerful step toward reforming the PBM system and lowering the cost of health care for all Americans.

“When Americans face soaring prices for medicines or treatments, there’s a good chance that is because a PBM has driven up the price. These middlemen operate with minimal transparency, and their practices distort the market, increasing the list prices patients pay for medicines while making it more difficult for manufacturers to offer quality, affordable health care benefits.

“By increasing transparency into PBMs’ business models and delinking their compensation from a medicine’s list price, these critical PBM provisions will significantly reduce costs for seniors who rely on Medicare for health care coverage. Congress should advance these important reforms.

“In addition, manufacturers encourage Congress to enact similar reforms in the commercial insurance market to bring down health care costs for manufacturing workers participating in employer-sponsored plans.”

-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.