Rutgers School of Nursing

President-elect Donald Trump’s two picks for the Federal Trade Commission are likely to usher in more life sciences deals while maintaining the agency’s pressure on pharmaceutical intermediaries. A review of public statements by Commissioner Andrew Ferguson — Trump’s choice to lead the regulator — and Mark Meador, his pick for another GOP slot, shows a strong focus on big tech and far less about drugmakers. That would be a departure from Biden-era Chair Lina Khan, who has made the pharma industry one of the agency’s primary anti-consolidation targets . Ferguson and Meador have often urged a lighter touch to antitrust, hinting at a more traditional review of consolidation than Khan’s effort to broaden the criteria for challenging biopharma deals . But the two Republicans share Khan’s skeptical view of pharmacy benefit managers, more commonly known as PBMs, that are under the agency’s microscope. Under Khan, the FTC deployed new antitrust theories to challenge pharmaceutical deals with less overlap and transactions involving drugs at early stages of development. Her legal strategy was pulled from a little-noticed workshop that the FTC held in 2022 on antitrust and drug prices, and expressed by challenges of deals between Amgen and Horizon Therapeutics , and Sanofi and Maze Therapeutics . With Ferguson and Meador joining Republican commissioner Melissa Holyoak, experts believe the life sciences industry is now in for an antitrust policy that’s more traditional — though still rigorous at times. “We’re anticipating that merger enforcement will look like the first Trump administration, which was based on traditional legal theories but still aggressive,” said Jeny Maier, a managing partner with Axinn, Veltrop & Harkrider. For example, toward the end of the first Trump administration in 2020, the FTC approved AbbVie’s $65 billion takeover of Allergan, with one stipulation: AbbVie had to divest overlapping drug products. To the majority who approved the deal, that marked an important concession and showed the agency had done its job. But in a blistering dissent that presaged Khan’s more expansive approach, then-Commissioner Rohit Chopra, a Democrat, criticized the FTC for not suing to stop the deal and said the remedy “misses the big picture, allowing pharmaceutical companies to further exploit their dominance.” Chopra’s frustration over the lack of legal action and a perceived failure to look at wider market forces foreshadowed the agency’s 2023 lawsuit to block Amgen’s $28 billion buyout of Horizon. The two companies didn’t sell competing products, but the FTC said that Amgen could use its portfolio of blockbuster medicines to entice payers to favor two Horizon drugs, thwarting potential competition. Ultimately, though, the deal closed with limited concessions. Antitrust expert Michael Carrier, a professor at Rutgers Law School, said he doesn’t expect the FTC to challenge acquisitions like this one in the future. Nor does he anticipate the agency will target deals involving early-stage drugs, like Sanofi’s attempt to acquire a Phase 1 asset from Maze. “Back to traditional pharma antitrust theories like pay for delay, product hopping and citizen petitions,” Carrier said. Under Khan, the FTC wasn’t always as aggressive as some companies feared. Last year, the agency cleared Pfizer’s $43 billion bid for Seagen , after Pfizer agreed to donate the rights to a cancer drug’s royalties to the American Association for Cancer Research. And the agency recently approved Novo Holdings’ $16.5 billion acquisition of Catalent, despite huge political pressure over the price of obesity drugs. But Khan’s FTC likely made some companies think twice about pursuing acquisitions in the first place. The shift in approach under the new picks is anticipated to ease antitrust pressure on dealmaking, experts say. Ferguson, one of two current Republican commissioners on the five-member FTC, in a memo recently obtained by the publication Punchbowl , said he plans to end “Khan’s war on mergers,” including “novel and legally dubious” cases. “Most mergers benefit Americans and promote the movement of capital that fuels innovation. Focus FTC resources on mergers that harm competition and hinder innovation,” the document states. Ferguson will have the power to reopen tougher merger guidelines that the agency debuted last year to crack down on what it called “harmful corporate consolidation.” Two current commissioners, Rebecca Kelly Slaughter and Alvaro Bedoya, in an open letter shared on X , criticized Ferguson’s memo for not mentioning the cost of healthcare or prescription medicines. “The document does propose allowing more mergers, firing civil servants and fighting something called the ‘trans agenda.’ Is all of that more important than the cost of healthcare and groceries and gasoline?” they asked. Bedoya and Slaughter did not respond to a request for comment. Nor did Ferguson or Meador. Meador — a partner at the law firm Kressin Meador Powers, who has worked as an FTC antitrust attorney and former advisor to Sen. Mike Lee (R-UT) — is seen as holding tougher enforcement stances than Ferguson. Still, it’s expected he won’t advance novel theories of harm given his ideological underpinnings. “We will continue to see active merge enforcement, but there’s a lot of traditional, accepted theories that the agency can apply,” former FTC official and antitrust attorney James Fishkin said. (Ferguson can be elevated to FTC chair without US Senate confirmation because of his current role as commissioner, while Meador must undergo a formal confirmation process.) It doesn’t seem the FTC is in for wholesale change when it comes to PBMs, an issue that’s attracted bipartisan support in Congress as well. In September, the agency sued CVS Caremark, Cigna’s Express Scripts, and UnitedHealth Group’s Optum Rx, alleging the companies are artificially inflating the cost of insulin. That followed an interim FTC report that called for further investigation into the consolidated PBM industry that was characterized as pushing around competing pharmacies and extracting favorable financial outcomes. In a statement at the time , Ferguson voiced support for many of the sentiments in the report, but said more needs to be done to “determine whether these findings are representative of market dynamics for other drugs.” “The Commission is responsible for protecting consumers in those markets by enforcing competition among suppliers and middlemen,” he wrote in the statement. “Competition may not be a panacea for rising healthcare prices in America, but we owe it to Congress and the American consumers to do what we can within our statutory mandate to confront this challenge.” Meador authored a 2011 publication in the Annals of Health Law titled “Squeezing the Middleman: Ending Underhanded Dealing in the Pharmacy Benefit Management Industry through Regulation.” “The challenges instigated by the behavior in the PBM industry are not anomalies that may be remedied by occasional litigation,” Meador wrote. “Rather, constant investigation and litigation would be necessary to policy PBMs and prevent or cure unfair and deceptive practices.” Potentially buoying the FTC, PBMs have become a bipartisan target. Last week, Sens. Elizabeth Warren (D-MA) and Josh Hawley (R-MO) introduced a bill in the Senate that would require healthcare companies that own health insurers or PBMs to sell pharmacy assets within three years. The Pharmaceutical Care Management Association, a trade group representing PBMs, didn’t respond to a request for comment. “PBMs are just incredibly unpopular politically, and I think that that is true across both Democrats and Republicans,” Maier said.

FRIDAY, Nov. 8, 2024 -- The supply of health care professionals available to provide HIV care is expected to continue to decline over the next five years, according to research published in the November/December issue of the Journal of the Association of Nurses in AIDS Care . Andrea Norberg, D.N.P., R.N., from the Rutgers School of Nursing in Newark, New Jersey, and colleagues conducted an anonymous survey of 1,004 prescribing clinicians currently providing HIV-related health care. The researchers found that clinicians who were younger and Black, advanced practice registered nurses, and family medicine physicians were more likely to report continuing with the same number of patients or increasing the number of patients in their HIV practice in the next five years. However, 17.8 percent of respondents reported plans to stop HIV clinical care wholly or to decrease the number of people living with HIV in their practice over the next five years. Retirement, administrative burden, and burnout were the most common reasons for leaving. "Our study provides new insights into the numbers and characteristics of clinicians who will be available to provide HIV care in the coming years," Norberg said in a statement. "This information will inform efforts to build the HIV workforce amid the ongoing shift from specialist care to primary care strategies."

Nearly all older U.S. citizens follow one of nine trajectories in their last three years, researchers say. A Rutgers Health analysis of millions of Medicare records has laid the groundwork for improving end-of-life care by demonstrating that nearly all older Americans follow one of nine trajectories in their last three years of life. "Identifying which paths people actually take is a necessary precursor to identifying which factors send different people down different paths and designing interventions that send more people down whatever path is right for them," said Olga Jarrín, the Hunterdon Professor of Nursing Research at Rutgers and corresponding author of the study published in BMC Geriatrics. The team pulled the final three years of clinical records from a randomly selected 10 percent of all 2 million Medicare beneficiaries who died in 2018. Analysis of how much personal care each patient received and where they received care revealed three major care clusters -- home, skilled home care and institutional care. Each cluster contains three distinct trajectories. Roughly 59 percent of patients fell into the "home" cluster, meaning they spent most of their last three years at home while friends and family helped them with any tasks they couldn't do for themselves. Such patients typically received little professional care, either in their own homes or in nursing homes, until the last year of life. Another 27 percent of patients fell into the "skilled home care" cluster, meaning nurses and other skilled professionals helped friends and family care for them inside their own homes for most of their final three years. The final 14 percent of patients fell in the "institutional care" cluster and spent most of their final three years either in hospitals or (more commonly) nursing homes, receiving nearly all necessary care from paid professionals. The researchers used a group-based trajectory modeling approach, evaluating associations between care trajectories and both sociodemographic and health-related metrics. Patients in both the skilled home care and institutional care clusters were more likely than patients in the home cluster to be female, Black, enrolled in Medicaid or suffering from dementia. Extensive use of skilled home care was more prevalent in Southern states, while extensive use of institutional care was more common in Midwestern states. "Our study not only identifies different patterns of care but also sheds light on the clinical and policy factors that dictate where and when patients receive care," said Haiqun Lin, lead author of the study and a professor of biostatistics who is also co-director of the Center for Health Equity and Systems Research within Rutgers School of Nursing. "Understanding these patterns is crucial for advance care planning, and ultimately, for achieving the triple aim of improving care experiences, reducing care costs, and improving care quality." The study is the first of several the researchers plan to base on their analysis of the Medicare data. Now that they have identified the trajectories that people actually follow in their last years of life, they will look for the key factors that direct people down each path and interventions that will help more people stick to the path they prefer. For most but not all people, that means one of the paths in the home cluster. "Most people want to stay at home with minimal professional help," said Jarrín, who also is the director of the Community Health and Aging Outcomes Laboratory within Rutgers Institute for Health, Health Care Policy, and Aging Research. "However, the goal for a significant minority of people is to avoid being a burden to family and friends, and such people tend to want professional care." Jarrín added: "Our goal isn't forcing people toward any particular type of care. It's helping them to plan for and get the care that's right for them." This research was supported by the National Institutes of Health's National Institute on Aging, grants R33AG068931 and R01AG066139.