Harmony is not often found between two of the most rambunctious senators on Capitol Hill, Bernie Sanders (I-Vt.) and Rand Paul (R-Ky.).
But it was on Tuesday as it drafted legislation from the Senate Committee on Health, Education, Labor and Pensions to re-approve the Food and Drug Administration’s user compensation program, which expires Sept. 30.
First approved in 1992, this user reimbursement program allows the FDA to collect fees from companies that file drug approval applications. It is designed to speed up the approval process. And it requires re-authorization every five years.
Congress sees this bill as a piece of legislation to pass, as it will be used to help fund the FDA and renew existing policies. As a result, it also functions as a vehicle for other proposals to reach the president’s office — especially those that couldn’t get there on their own.
And so Sanders took advantage of the must-pass moment on Tuesday to propose a user fee change that would allow imports of drugs from Canada and the United Kingdom and, after two years, from other countries.
Prescription drugs are often much cheaper in other countries, and studies show that millions of Americans have purchased drugs from abroad, even though it is technically illegal.
“We’ve been talking about reimports for countless years,” said a visibly heated Sanders. “This bill really does it. It doesn’t wait for someone in the bureaucracy to make it happen. It really makes it possible.” Then he went on for several minutes, his tone escalated, citing statistics about high drug prices, telling anecdotes of people traveling for drugs, and ending with outrage at drug companies’ campaign contributions and the number of lobbyists the industry has.
“I’ve always wanted to go to a Bernie rally, and now I feel like I’ve been there,” Paul joked after Sanders finished speaking. He went on to offer his support for the Vermont Senator’s Amendment — a rare bipartisan alliance between senators who are on opposite sides of the political spectrum.
“This is a policy that unites many on both sides of the aisle, the outrage at the high prices of drugs,” Paul added. He said he was not in favor of drug price controls in the US, but favor a global competitive free market for drugs, which he believes would lower prices.
Even before Sanders offered his amendment, the user fee bill before the commission contained a limited provision on drug imports, Sec. 906. The FDA should develop rules for importing certain prescription drugs from Canada. But how this provision differs from a Trump-era regulation is unclear, said Rachel Sachs, a law professor at Washington University in St. Louis and an expert on drug pricing.
“FDA has already drafted import regulations that were finalized at the end of the Trump administration,” Sachs said. “We haven’t seen anyone try to get an approval” under that directive. She added that whether Sec. 906 does anything to improve existing regulations is unclear.
Sanders’ proposed change would have gone further, Sachs explained.
It would have included insulin among the products available in other countries. It would also have forced pharmaceutical companies to comply with the regulation. It has been a concern in drug pricing circles that even if imports were allowed, there would be resistance in other countries because of how the practice could affect their domestic supply.
A brisk discussion between Republican and Democratic senators ensued. One of the most notable moments: Sen. Mitt Romney (R-Utah) asked if importing drugs from countries with price controls would translate into some form of price controls in the US Sen. Tim Kaine (D-Va.) said his father got the law by getting his glaucoma medication from Canada.
The committee chair, Senator Patty Murray (D-Wash.), held the line against Sanders’ amendment. While agreeing with some of her policies, she said, she wanted to stick with the import framework already included in the bill, rather than make changes that could jeopardize its adoption. “Many of us want to do more,” she said, but the bill in its current form “is a huge step forward and it has the Republican support we need to pass legislation.”
“To my knowledge, this is the first time ever that a user fee re-authorization bill has included the import of prescription drugs,” Murray says. “I think it will prepare us well to make further progress in the future.”
sen. Richard Burr (RN.C.), the committee’s chief member, was adamant in his opposition to Sanders’ amendment, saying it spelled the ruin to the overall prospects of the legislation. “Do you want to abolish this account? Do imports,” Burr said.
Sanders, however, stayed true to his reputation, not being silent or giving up the fight. Instead, he called for an immediate vote. “This is a real debate. There were disagreements. That’s called democracy,” he said. “I would urge those who support what Senator Paul and I are trying to do here to vote for it.”
But in the end, the committee members did not and chose to table the amendment, meaning it was set aside and not passed into law.
Later in the afternoon, the Senate panel met again after the senators attended their weekly party policy lunches and passed the user fee bill from the Committee 13-9. The next step is the consideration by the full Senate. A similar bill has already been approved by the House of Representatives.
KHN (Kaiser Health News) is a national editorial that produces in-depth journalism on health issues. Together with Policy Analysis and Polling, KHN is one of the three major operational programs of KFF (Kaiser Family Foundation). KFF is an endowed non-profit organization that provides information on health issues to the nation.
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