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As Trump, Biden face off, could drug pricing reforms await? Experts are split, but pharma is watching closely

During most political campaigns, the subject of drug pricing is front and center. And in recent years, despite promises by politicians in both parties, efforts to lower U.S. prices have mostly come up short. Amid the COVID-19 pandemic, though, the issue of pricing has never taken center stage on the 2020 campaign trail. But thanks to the health and financial challenges affecting millions of Americans, it’s as important as ever.

So how can patients and their families expect drug prices to change depending on the results?

No matter who wins the White House and Senate, fighting high drug prices is going to be “near the list of the top of the priorities for the government next year,” said David Mitchell, founder of Patients for Affordable Drugs.

“Even in the face of a pandemic, even in the face of all of the issues that are in play outside of healthcare, drug prices continues to be an issue that animates voters,” he said.

For the government, there’s a “practical impact” that drug pricing legislation can save money when budgets are expected to be tight. Those combined factors make it more likely there will be action after the election than compared with prior years, Mitchell said.

Stacie Dusetzina, an associate professor at Vanderbilt’s Department of Health Policy, sees things a little differently. Although the Trump administration “put forward a lot of drug pricing proposals” in the president’s first term, those initiatives didn’t materialize. Dusetzina said she’s not sure how much action to expect if President Donald Trump wins a second term.

Congressional efforts could come together if Trump wins, Dusetzina figures. Lawmakers from both parties have already put forth a range of drug pricing bills, so they could work to find common ground on popular initiatives such as Medicare reform or an out-of-pocket cap for patients.

In a Biden presidency, health insurance and the coronavirus pandemic seem like obvious priorities, Dusetzina said. She believes there would be a focus on drug prices as well.

Rachel Sachs, a law professor at Washington University in St. Louis, meanwhile, said it’s “most likely” the U.S. will see pricing actions if Biden wins the presidency and Democrats take control of the Senate. The Trump administration has made pricing a “talking point,” but they have “relatively little to show for their efforts,” she said.

Many of the administration’s “more impactful policies … remain stuck in draft form,” Sachs said, and there’s no reason to believe the government has “concrete plans to put them into effect.”

Immediately after the election, COVID-19 will still be the dominating subject in American politics, Walid Gellad, director of the the University of Pittsburgh’s Center for Pharmaceutical Policy and Prescribing, said via email.

“I don’t think we’re going to see major drug pricing initiatives until COVID is behind us,” he wrote. “It depends on what happens in Congress as well, since the makeup of Congress and the executive branch will determine how likely it is we will see legislative action versus more administrative actions” on a smaller scale.

How do the candidates propose fighting high drug prices?

Trump this summer unveiled a range of executive orders to take on drug prices, including his “favored-nations clause” that aims to tie prices in Medicare Part B and Part D to cheaper prices abroad.

Aside from that plan, Trump has proposed capping out-of-pocket costs in Part D and issued a rule allowing importation if drugs are proven safe. Trump’s other executive orders centered on creating discounts for certain meds and eliminating rebates. Before that, back in 2018, the administration unveiled a pricing blueprint with a focus on low-cost generics and biosimilars, taking on patent “gaming” and more.

For his part, Democratic challenger Joe Biden proposes allowing the federal government to negotiate with drugmakers, a stance previously held by Trump, who has since backed away from his support of Medicare price negotiations. Biden further proposes forming a panel to independently review drug benefits and determine fair prices, plus capping drug price increases to the rate of inflation.

There are many other ideas and subjects up for consideration ranging from how to approach DTC advertising, “pay-for-delay” deals and more. The Commonwealth Fund has posted an in-depth breakdown of the candidates’ varying approaches.

As president, Trump’s record on drug pricing is mixed. Before taking office, he said pharma companies were “getting away with murder” and that he’d implement competitive bidding programs to drive prices down. That hasn’t happened, but his administration kept a focus on the issue through his first term, including with the 2018 blueprint.

Some of the administration’s big goals—such as including prices in TV ads and eliminating rebates—haven’t panned out for one reason or another, but attention to drug prices has made pharma companies more careful about their price hikes. Prescription drug prices grew by 2.8% in 2017, fell by 0.6% in 2018 and grew by 3% in 2019, according to the Bureau of Labor Statistics.

Trump signed a law banning “gag clauses” that prohibited pharmacists from telling patients about cheaper methods to pay for their prescriptions, according to the Commonwealth Fund, and another law discouraging “pay-for-delay” deals that lead to higher prices. The administration has also kept a focus on approving generics and biosimilars to increase competition.

Amid a potential Biden administration drug pricing push, Sachs said she could see the “three pillars” of the House of Representatives’ H.R. 3 bill remaining intact—controlling out-of-pocket costs, discouraging price hikes and negotiating prices. There are still questions about implementing the proposals, though.

“As always, our system is extremely fragmented and different drugs have high prices for different reasons,” Sachs said. “We might help some patients … and other patients would still have issues affording their medication.” Various types of reform are needed, she said.

How are drugmakers approaching the election?

On analyst calls last week, pharma CEOs were all careful to not offer any definitive expectations when it came to the upcoming election.

Eli Lilly CEO David Ricks said the industry sees two major issues with U.S. pricing and access—out-of-pocket costs and “distortions” in the system that create “artificial winners and losers.”

The post-election landscape is “not defined,” he added, “so we’ll need to wait for that to land before we get into too many speculations about that future environment.”

Pfizer, meanwhile, is “committed to working with both parties in Washington to put patients first,” CEO Albert Bourla said, touting policies such as reforming Medicare Part D to include an out-of-pocket cap and pass rebates back to patients.

“Regardless of what happens in November, we will be ready to take a seat at the table and play a constructive role in shaping the debate for the benefit of the patients,” Bourla said.

Sanofi, for its part, is “more than prepared to demonstrate our value, whatever the administration, and will bring our very best to that,” CEO Paul Hudson said last week.