[UPDATED on June 21]
Harmony is not often found between two of the most boisterous senators on Capitol Hill, Bernie Sanders (I-Vt.) and Rand Paul (R-Ky.).
But it was there at Tuesday鈥檚 Senate markup of to reauthorize the Food and Drug Administration鈥檚 user fee program, which is set to expire Sept. 30.
This , which was first authorized in 1992, allows the FDA to collect fees from companies that submit applications for drug approval. It was designed to speed the approval review process. And it requires reauthorization every five years.
Congress considers this bill a must-pass piece of legislation because it鈥檚 used to help fund the FDA, as well as revamp existing policies. As a result, it also functions as a vehicle for other proposals to reach the president鈥檚 desk 鈥 especially those that couldn鈥檛 get there on their own.
And that鈥檚 why, on Tuesday, Sanders took advantage of the must-pass moment to propose to the user fee bill that would allow for the importation of drugs from Canada and the United Kingdom, and, after two years, from other countries.
Prescription medications are often much less expensive in , and show that millions of Americans have bought drugs from overseas 鈥 even though doing so is technically illegal.
鈥淲e have talked about reimportation for a zillion years,鈥 said a visibly heated Sanders. 鈥淭his bill actually does it. It doesn鈥檛 wait for somebody in the bureaucracy to make it happen. It actually makes it happen.鈥 He then went on for several minutes, his tone escalating, citing statistics about high drug prices, recounting anecdotes of people who traveled for drugs, and ending with outrage about pharmaceutical companies鈥 campaign contributions and the number of lobbyists the industry has.
鈥淚 always wanted to go to a Bernie rally, and now I feel like I鈥檝e been there,鈥 Paul joked after Sanders finished talking. He went on to offer his support for the Vermont senator鈥檚 amendment 鈥 a rare bipartisan alliance between senators who are on opposite ends of the political spectrum.
鈥淭his is a policy that sort of unites many on both sides of the aisle, the outrage over the high prices of medications,鈥 added Paul. He said he didn鈥檛 support drug price controls in the U.S. but did support a worldwide competitive free market for drugs, which he believes would lower prices.
Even before Sanders offered his amendment, the user fee bill before the committee included a limited drug importation provision, Sec. 906. It would require the FDA to develop regulations for importing certain prescription drugs from Canada. But how this provision differs from a Trump-era regulation is unclear, said , a professor of law at Washington University in St. Louis and an expert on drug pricing.
鈥淔DA has already made importation regulations that were finalized at the end of the Trump administration,鈥 said Sachs. But no applications under the directive have been approved yet. She added that whether Sec. 906 is doing anything to improve the existing regulation is unclear.
Sanders鈥 proposed amendment would have gone further, Sachs explained.
It would have included insulin among the products that could be obtained from other countries. It also would have compelled pharmaceutical companies to comply with the regulation. It has been a concern in drug-pricing circles that even if importation were allowed, there would be resistance to it in other countries, because of how the practice could affect their domestic supply.
A robust discussion between Republican and Democratic senators ensued. Among the most notable moments: Sen. Mitt Romney (R-Utah) asked whether importing drugs from countries with price controls would translate into a form of price control in the U.S. Sen. Tim Kaine (D-Va.) said his father breaks the law by getting his glaucoma medication from Canada.
The committee鈥檚 chair, Sen. Patty Murray (D-Wash.), held the line against Sanders鈥 amendment. Although she agreed with some of its policies, she said, she wanted to stick to the importation framework already in the bill, rather than making changes that could jeopardize its passage. 鈥淢any of us want to do more,鈥 she said, but the bill in its current form 鈥渋s a huge step forward, and it has the Republican support we need to pass legislation.鈥
鈥淭o my knowledge, actually, this is the first time ever that a user fee reauthorization bill has included policy expanding importation of prescription drugs,鈥 Murray said. 鈥淚 believe it will set us up well to make further progress in the future.鈥
Sen. Richard Burr (R-N.C.), the committee鈥檚 ranking member, was adamant in his opposition to Sanders鈥 amendment, saying that it spelled doom for the legislation鈥檚 overall prospects. 鈥淲ant to kill this bill? Do importation,鈥 said Burr.
Sanders, though, staying true to his reputation, didn鈥檛 quiet down or give up the fight. Instead, he argued for an immediate vote. 鈥淭his is a real debate. There were differences of opinions. It鈥檚 called democracy,鈥 he said. 鈥淚 would urge those who support what Sen. Paul and I are trying to do here to vote for it.鈥
In the end, though, committee members didn鈥檛, opting to table the amendment, meaning it was set aside and not included in the legislation.
Later in the afternoon, the Senate panel reconvened after senators attended their weekly party policy lunches and passed the user fee bill out of the committee 13-9. The next step is consideration by the full Senate. A similar bill has already cleared the House.
[Correction: This article was revised at 12:15 p.m. ET on June 21, 2022, to specify that no approvals have yet been granted under a Trump administration importation regulation. Some states have either filed or are contemplating filing applications under that directive.]
