While the Association for Accessible Medicines’ Access! 2025 meeting represented the generics and biosimilars group’s first annual conference with its new president and CEO John Murphy at the helm, delegates at the event were more focused on a different change in administration – namely, the second US presidency of Donald Trump.
Immediately after a weekend that saw Trump cause global upheaval with threats of immediate tariffs on Canada, Mexico and China, as well as potential tariffs on the EU – only for the enforcement of US tariffs on the country’s closest neighbors to be postponed, at least for now, as action on China proceeded – attendees to the AAM event in Amelia Island, Florida this week heard Murphy’s views on the risks presented by the tariffs, but also the lobbying opportunities provided by the new Trump administration.
A dedicated session of the annual AAM meeting also saw panelists discuss in detail what to expect from the US president’s second term, while talk of the latest political movements from the second Trump administration inevitably found its way into most other conversations too – both on the conference stage as well as on the sidelines.
“Poorly planned and executed tariffs could decimate portions of our industry in the United States and significantly harm patient care.”
Commenting on the risks presented by potential tariffs, Murphy reiterated the position expressed recently by the AAM that the trade measures could risk supply shortages for essential medicines, as well as piling the burden of unbearable additional costs on an already stressed off-patent industry.
“To be sure, proposed tariffs that might impact our supply chain would benefit no one and produce very little in terms of US advantage,” Murphy made clear during his opening address to the conference. “In fact, poorly planned and executed tariffs could decimate portions of our industry in the United States and significantly harm patient care and hamper US healthcare security.”
Similarly, Murphy said, the Trump administration’s “reorganizations, retirements and uncertain priorities surrounding the US Food and Drug Administration and its place as the gold-standard regulator threaten the role of the agency in ensuring the safety and security of our drug supply chain.”
“But our shared advocacy can unquestionably overcome these obstacles,” Murphy insisted optimistically. “We are already hard at work in Washington with our members, allies, and patients to clarify policy concerns and educate on the critical importance of the industry for patients and to the United States healthcare and national security,” he noted, confirming that industry would be hoping for an exemption for pharmaceuticals from any future tariffs.
AAM Policy Proposals Would Support Government’s Goals
However, alongside the threat of tariffs, for Murphy the new US administration also represented a potential opportunity for the off-patent sector to get its foot in the door and gain traction for “fundamental policy reforms surrounding the generic and biosimilars market” that the industry would like to see.
“Fortunately, we sit here at a time where a new government is crying out for support in reforming government regulatory programs, enhancing US competitiveness and innovation and manufacturing, and reducing the costs borne by government and patients in our healthcare system,” the AAM president set out. And “the generics and biosimilars industry stands at the heart of supporting all of these stated goals.”
“A robust generics and biosimilars market with appropriate reimbursement and ready patient access can unquestionably lower healthcare costs,” he underlined. “This combination can also spur investment in manufacturing and economic development and ultimately serve as a harbinger of the many positive changes that can follow.”
“AAM is highlighting a suite of regulatory and legislative proposals meant to restore the sustainability of the generic market in the United States, increase patient access and affordability to our medicines, and begin policy reforms that will enhance the value of investment and resiliency,” he pointed out.
And “to be sure, in our budget-focused government landscape, the majority of our proposals will also save the government money over the next many years,” which he described as “a win for patients, a win for industry, and a win for the government. We simply need to keep the momentum on a positive course.”
“The way Trump goes about things is, kind of, let’s roll a big stink bomb into the room.”
Speakers participating in the dedicated panel on what industry could expect from the new Trump administration were somewhat less circumspect and diplomatic – although Alex Brill, senior fellow at the American Enterprise Institute, did agree that the new administration “creates opportunities I think, quite frankly, for a lot of regulatory reform.”
Paul Heldman, research analyst for health policy at Nephron Research, observed that Trump “backing off on Canadian tariffs and Mexican tariffs for 30 days as markets tanked around the world,” was “an indication that Trump is very transactional,” meaning that industry also had to think about his approach to policy in this way.
And Dean Rosen, partner at Mehlman Consulting, cautioned over the unpredictability of Trump’s negotiating tactics. “I think the way he goes about things is, kind of, let’s roll a big stink bomb into the room and throw things up and say, you’re not going to really know where I’m coming from,” he suggested.
Rosen also suggested that another “really big change between Trump 1.0 and 2.0” was the “much more Trumpian” makeup of the current Republican party compared to Trump’s first term as president, when more moderate voices were in key leadership positions. But now, “in the cabinet nominees, for the most part, you’ve got nobody there who is looking to restrain him.”
“So you have a much more Trumpian party, which by definition, I think to your point Paul, is going to be a little bit more transactional, is going to be a little bit less what people used to think about as conservative principles.”
Ultimately, however, Rosen said “this election really wasn’t about healthcare and Trump is not really a healthcare guy”, with the president likely to effectively outsource the area to his political appointees.
Brill agreed. “I do get this impression that there are folks around the president who see healthcare primarily as a budget policy issue…without coming from the perspective of, what’s the policy here, what are the outcomes, why is it what it is, who are the stakeholders? They just see really big dollar signs.”
“And so that brings in issues like Elon Musk and DOGE [Department of Government Efficiency] and folks that are in the wings working on pushing spending policies.”
US Manufacturing Base Unlikely To Change
Panel moderator Katherine Raab, vice president for federal government affairs at the AAM, posed the question of whether panelists expected government policies to favor domestic manufacturing in the US, with some off-patent firms already having hinted at this as a possible long-term option.
“Rhetorically, I think we’re going to continue to hear, as we heard in the last administration and the administration before, and in fact for quite a long time, how great it is to make stuff in this country,” Brill said. “And that’s not a new idea.” But this would not necessarily translate to tangible policy, he suggested, with little on the horizon that would “radically change the US manufacturing base.”
“We’ve had tax policies that are targeted at domestic investment. We’ve had a lot of conversations in the last few years about where our drugs are coming from, and wouldn’t it be nice if more of them were made here, where we could inspect them more easily and more readily and also where we were in more control from a security perspective,” he said. And “I think we’re going to continue to hear those conversations.”
But “I think it’s very difficult to craft tangible effective policies that are going to result in changes in decision-making around the boardroom table in terms of where people are going to source,” he suggested. “You can get people to stop sourcing out of China, but that doesn’t mean that they’re going to source in the United States.”
With the panel acknowledging a lot of unknowns around Trump’s general intentions and specific policy priorities for the sector, the only certainty about Trump and his administration seemed to be that the off-patent industry was in for plenty more uncertainty to come, with a sense of exhaustion already evident from some panelists as a result of Trump’s volatile leadership style.
“We’re only two weeks and one day in,” Raab joked during the Tuesday session, “and yet it feels like seven years.”
