Drug and device makers welcomed the results of a general election expected to significantly impact their industry, even though the president-elect's stances are sometimes at odds with their own.
Throughout his campaign, Republican Donald Trump stressed the need to curb rising drug prices and vowed to repeal the controversial 2.3% medical-device tax that was enacted in 2010 under the Affordable Care Act. He has spoken less about changes to the Food and Drug Administration's approval processes, but a law similar to the 21st Century Cures Act intended to speed up approvals is more likely to pass under a Republican-controlled Congress and White House.
Trump favors casting light on the factors behind high healthcare costs, wants to import drugs from other countries and allow Medicare to directly negotiate on drug prices—all measures that could theoretically bring prices down, but efforts that are opposed by the drug lobby.
In fact, Proposition 61, a California ballot initiative that ties the prices state agencies pay for prescription drugs to the discounts negotiated by the U.S. Veterans Affairs Department, drew more than $100 million in spending from opponents, most of it from the pharmaceutical industry. The measure failed.
On Wednesday morning, the CEO of Pharmaceutical Research and Manufacturers of America said the lobbying group looks forward to working with the next Congress and Trump administration.
“We are in a new era of medicine with treatments and cures that are completely transforming the fight against debilitating diseases,” PhRMA CEO Steve Ubl said. “To ensure this innovation continues, we need to modernize the FDA to keep pace with scientific advances, remove regulatory barriers that make it harder to move to a value-driven healthcare system and focus on making better use of the medicines we have today."
Blair Childs, senior vice president of public affairs for group purchasing organization Premier, believes that a curb on drug pricing will ultimately come from a speedier FDA approval process or a shortening of patent exclusivity, and not direct regulatory action or executive pressure. But Congress will need to address exorbitant healthcare spending and Republicans need to understand the role of GPOs in that process, Childs said.
“Republicans are firm advocates for competition and choice, and GPOs are really built on the notion of competition and choice,” Childs said. The biggest critics of the GPO industry tend to be Democrats, including Sen. Richard Blumenthal (D-Conn.), who says GPOs influence healthcare costs. He was re-elected to a six-year term Tuesday.
Under a Trump presidency, drugmakers and devicemakers alike are hoping for a more nimble FDA and an overall political climate that is, in their words, “pro-innovation.” Trump's promise to repeal the medical-device tax is more-than-welcome news for the Advanced Medical Technology Association, the devicemaker lobby known as AdvaMed, though its CEO maintained in a statement that the issues at hand have always been “bipartisan issues.”
“The medical technology community stands ready to work with President Trump, his administration and the new Congress on pro-innovation policy solutions to address the healthcare challenges facing the country and to ensure all Americans have timely access to the latest medical technologies, devices and diagnostics,” said Scott Whitaker, AdvaMed's president and CEO.
FDA policies and regulations could be influenced by whether FDA Commissioner Robert Califf decides to stay on with a Trump administration. Experts say he should be able to transition smoothly into a Republican administration that supports speeding up the agency's processes.
"It wouldn't surprise me if Califf stuck around. I think it's a job he wants to have,” said Jim Shehan, head of Lowenstein Sandler's FDA regulatory practice.
But ultimately there are many unknowns for the medical manufacturing industry, said Shehan, a former FDA official and former general counsel for drugmaker Novo Nordisk. Trump didn't campaign as pro-industry, but rather said that he'd fight for the working American. The healthcare leaders he appoints will be key to gauging the future of his presidency, experts agree.
“There's no one who has a lot of insight into what Trump's thoughts and policies will be on drug industry-specific issues,” Shehan said. “If someone tells you that they do, they're just lying.”
