| It was a wild week at the JPMorgan confab, where the usual spate of deal announcements was accompanied by admiration for China’s strength as a drug developer and a lot of talk about the new occupant of the White House. In his inaugural speech Monday, President Donald Trump said that the US spends more money on health care “than any country anywhere in the world.” He wants to put tariffs on imported goods and get rid of drug middlemen. He’s also promised to ease federal regulations on businesses. His nominee to head the Department of Health and Human Services, Robert F. Kennedy Jr., has linked vaccines to autism and wants Americans to eat better rather than take weight-loss drugs to battle obesity. “The new administration will bring radical change,” said Albert Bourla, CEO of Pfizer. “There are several people that think for our industry, the risks outweigh the opportunities. There are other people — among them, myself — who think that the opportunities outweigh the risks.” Here’s what other executives at the conference had to say: Stephen Ubl, CEO of the Pharmaceutical Research and Manufacturers of America: “We did spend a fair amount of time talking about the need for PBM reform,” referring to his discussions with Trump about pharmacy benefit managers at a Mar-a-Lago dinner along with the CEOs of Pfizer and Eli Lilly. Trump “has a previous interest in this area with a rebate rule and I think he has a keen understanding of how it’s forcing patients to pay more for their drugs than they should.” On Kennedy: “Next to clean water, vaccines have driven incredible public health gains. He’s going to get questions about these policies in the context of the nomination process, and he should.” “Let’s face it, the previous administration was challenging. They tried to waive our intellectual property protections in the context of Covid therapeutics.” “They tried to redefine Medicaid best price. They added additional CMS requirements in the context of Alzheimer’s medicines, to FDA approved medicines, for the first time, which slowed patient access to those medicines. I think there’s a sense of optimism that we will at least have more constructive engagement with this administration.” — Madison Muller Albert Bourla, CEO of Pfizer: On Kennedy: “The things that he has said about vaccines in the past are in complete contradiction with what we believe and what the medical community believes and what the scientific community believes and what regulators all over the world believe. Vaccines are the most effective, cost-effective health-care intervention since clean water.” “The president-elect is very much focused on cancer. He has seen a lot of his friends and people that he knew dying from cancer. And he keeps asking every time we meet: ‘What are we doing with cancer, and can we cure it?’ And I think that’s an opportunity to try to build programs that will accelerate cancer development.” “This new administration, they have a very deep belief that to make America great again, they need business to be great, the private sector to be great, entrepreneurship to be great. They truly think one of the biggest levers they have is to support business.” Trump “doesn’t like, of course, that here people are paying a lot for their medicines compared to Germany. But also he appreciates that here there are middlemen who are inflating the out-of-pocket disproportionately.” — Damian Garde Shreeram Aradhye, chief medical officer at Novartis: “People are in a bit of a wait-and-watch mode.” “There seems to be a clear difference between what is said than what actually gets done, what can actually be legislated, and then how long it lasts.” “Of course people are changing. But then how will that dramatically change what we do, unless there's some big disruption, things start getting delayed, which we know didn’t happen” in the last Trump administration. “The government continued functioning.” — Naomi Kresge John Maraganore of Jefferies, former CEO at Alnylam: “I think everybody would welcome more modernization of the FDA. I mean, the pace of science has accelerated amazingly. And there are some pockets within the FDA that may not have advanced as quickly as how the science has advanced.” “There are some that are just very old fashioned and conservative. And so if there’s a way of using this change in a positive way, as long as it maintains the right scientific standards. We need to have the FDA as the world’s gold standard regulatory agency driven by scientific excellence, so that the public trusts what the FDA approves.” — Gerry Smith Adam Keeney, head of corporate development at Biogen: “Chaos is sometimes part of what they're trying to do, right? But the problem with that is just there are some very fundamental things the FDA has to do. Not just regulate food, but also drugs, and get new drugs approved and inspect manufacturing facilities, etc, and so that needs to continue.” — Gerry Smith Doug Ingram, CEO of Sarepta Therapeutics: “I am somewhere between sanguine and optimistic that things are going to go well with the FDA in the future.” Marty Makary, Trump’s pick to lead the agency, “has an extraordinarily impressive resume. I suspect he is going to have a mandate to modernize the FDA." “He could be a fantastic ally” if he works to make expedited approval standards more consistent across the agency’s divisions. — Robert Langreth | 
