Trump election sends aftershocks through biotech sector
Donald Trump's surprise election to succeed US President Barack Obama is prompting many questions for the biotech industry, chief among them are the fates of several Obamaera laws and initiatives. As the Trump administration teams with a Republican Congress eager to loosen regulations, this will inevitably jolt government agencies that play critical roles in drug discovery, development and market access. Campaign era promises to dissolve or renegotiate global trade deals and drug pricing positions remain wildcards for industry. Meanwhile, tax reforms may turn up the heat on industry's already warm climate for acquisitions. A top priority will be the Patient Protection and Affordable Care Act (PPACA) healthcare reform law. (Nat. Biotechnol. 28, 385 386, 2010) Obamacare, as it is commonly known, appears extremely vulnerable as it has been chief among Republican bugbears since its enactment in 2010. But the full repealand replace promised often by vociferous Republicans (including Trump) over the past several years may not be legislatively possible. And it would leave 20 million Americans with no access to health insurance. For biotech, a PPACA repeal would remove the nascent biosimilar approvals pathway that was created as part of Obamacare, and would reduce the number of US citizens who can afford new drugs. A brief policy outline posted to Trump's website two days after the election promised to replace the PPACA. But "the only honest answer is that no one really knows" what exactly will happen to President Obama's signature healthcare reform law, says Michael McCaughan, founder of health policy analysis firm Prevision Policy in Washington, DC. Congressional Republicans who long sought the law's repeal, "never expected to be in this position," he says. With Trump as president and Republicans controlling Congress, US federal spending will most probably shrink. Any cuts could have negative ramifications for the National Institutes of Health (NIH) and Obama era NIH projects that require Congressional funding. Hopes that the new administration might embrace scientific rigor received an early blow when a climate change contrarian Myron Ebell of the Competitive Enterprise Institute in Washington, DC, was tapped by Trump to lead the transition at the US Environmental Protection Agency. As of mid November Trump hadn't disclosed any actual policy positions related to the NIH, but during a radio interview with Michael Savage in October, he stated: "I hear so much about the NIH, and it's terrible." Initiatives that are key to Obama's legacy will likely be under renewed scrutiny. Funding to support the $350 million neuroscience research program BRAIN (Brain Research through Advancing Innovative Neurotechnologies) (Nat. Biotechnol. 31, 460, 2013) and the patient empowered Precision Medicine Initiative (PMI) (Nat. Biotechnol. 33, 325, 2015) a large scale research effort aimed at gathering and linking genomic, phenotypic and lifestyle data to accelerate R&D, could be in jeopardy. The fate of the Cancer Moonshot program, launched in early 2016 to facilitate collaboration and data sharing in oncology, with a goal to double the rate of progress in cancer prevention, diagnosis and treatment, also remains unclear. Moonshot is spearheaded by Vice President Joe Biden, and includes industry players, clinicians and academic institutions (Nat. Biotechnol. 34, 118, 2016) It enjoys widespread support and, before the election, Moonshot leaders expressed optimism about the program's momentum. "We can get a lot of things started that are not going to stop regardless of what happens to the Moonshot as a governmental entity," Washington, DC based Moonshot executive director Greg Simon noted during a November 4 conference convened by the Washington, DC based research advocacy group Friends of Cancer Research and Prevision Policy. The fate of NIH's recently announced clinical trial access and data transparency policies is now uncertain. These apolitical aspirations related to Moonshot announced in October (JAMA 316, 1353 1354, 2016) including improved access to clinical trials and better communication between NIH cancer centers, are unlikely to be controversial. But although Simon reached out to the Trump campaign about the future of the Moonshot, he has yet to receive a response. Still, he said, "I've been in Washington since 1985..and I've never been associated with a program that has more bipartisan support and more excitement from the average citizen than the Moonshot." At least in some form, the Obama administration's projects will survive the transition to Trump's presidency, health policy experts agree. It's unclear whether they'd be funded at Obama administration levels, but "if there's anything that's enjoyed bipartisan support, it's funding for the NIH," says Ian Spatz, senior advisor at Washington, DC, healthcare consultancy Manatt Health and a former vice president of public policy at Merck Co. "I can't imagine there'll be any change in that going forward," he says, and what's more, "it would be really smart politically for the president elect to embrace Joe Biden's Moonshot." Issues around drug pricing may vex the Trump administration as much as its London reacts to the US presidential election. N ig el B ow le s/ A la m y Li ve N ew s N E W S
Nature Biotechnology