Harmony is not often found among the two most outspoken senators on Capitol Hill, Barney Sanders (I-VT) and Rand Paul (R-Kai.).
But Tuesday’s Senate Health, Education, Labor and Pensions Committee markup had legislation to re-approve the Food and Drug Administration’s user fee program, which is due to expire on September 30.
This user fee program, first approved in 1992, allows the FDA to collect fees from companies that submit applications for drug approval. It is designed to speed up the approval review process. And it requires approval every five years.
Congress considers the bill a by-pass part of the law because it is used to fund FDA funds, as well as to help restructure existing policies. As a result, it also serves as a vehicle for other proposals to reach the President’s desk – especially those that could not get there on their own.
And that’s why, on Tuesday, Sanders took advantage of the passing moment to propose an amendment to the User Fee Bill that would allow imports of drugs from Canada and the United Kingdom, and two years later, from other countries.
Prescription drugs are often much less expensive in other countries, and studies show that millions of Americans buy drugs from abroad – although it is technically illegal to do so.
Apparently heated, Sanders said, “We’ve been talking about re-importing for a million years.” “It simply came to our notice then. It doesn’t wait for anyone in the bureaucracy to make it happen. It really helps to make it happen. “He then goes on for a few minutes, raising his voice, quoting high drug price statistics, narrating anecdotes about people traveling for drugs, and ending with frustration about the pharmaceutical company’s campaign contributions and the number of industry lobbyists.
“I’ve always wanted to go to a Barney rally, and now I feel like I’ve been there,” Paul joked after Sanders finished. He offered his support for the Vermont senator’s amendment – a rare bipartisan alliance among senators on the opposite end of the political spectrum.
“It’s a policy that unites many on both sides of the aisle, outraged at the high cost of medicine,” Paul added. He said he did not support drug price controls in the United States but did support the global competitive open market for drugs, which he believed would reduce prices.
Even before Sanders proposed his amendment, the Committee on User Fees before the committee had included a provision for the importation of limited drugs, Sec. 906. The FDA is required to make regulations for the importation of certain prescription drugs from Canada. But it’s not clear how the provision differs from the Trump-era regulations, said Rachel Shass, a law professor and drug pricing expert at Washington University in St. Louis.
“The FDA has already drafted import regulations that were finalized at the end of the Trump administration,” Schach said. Under that directive, “we did not see anyone trying to get approval.” He added that Sec. It is not clear if 906 is doing anything to improve existing controls.
Sanders’ proposed amendment would have gone further, Shas explained.
This will include insulin in products from other countries. It will also force pharmaceutical companies to comply with the rules In drug-pricing circles it was a matter of concern that even if imports were allowed, it would be prevented in other countries, as this practice could affect their internal supply.
There has been a heated debate between Republicans and Democratic senators. Among the most notable moments: Sen. Mitt Romney (R-Utah) asked if importing drugs from countries with price controls would become a form of price control in the United States. Sen. Tim Cain (D.V.) said his father broke from Canada. The law brought his glaucoma drugs.
The chairman of the committee, Sen. Patty Murray (D-Wash), lined up against Sanders’ amendment. Although he agreed with some of the principles, he said he wanted to stick to the existing import structure in the bill, rather than make changes that could jeopardize its passage. “Many of us want to do more,” he said, but the bill in its current form is “a huge step, and it has the Republican support that we need to pass legislation.”
“To my knowledge, in fact, this is the first time that a user fee re-approval bill has included a policy to expand the import of prescription drugs,” Murray said. “I believe this will set us up for further progress in the future.”
Sen. Richard Burr (RN.C.), a ranking member of the committee, was adamant in his opposition to Sanders’ amendment, saying it would be a defeat for the overall potential of the law. “Want to kill this bill? Import, ”Burr said.
Sanders, however, remained true to his reputation, never calming down or giving up the fight. Instead, he immediately argued for a vote. “It simply came to our notice then. There was a difference of opinion. It’s called democracy, “he said. “I urge those who support Sen. Paul and me to vote for what I am trying to do here.”
In the end, though, committee members did not like to introduce the amendment, which meant it was set aside and not included in the law.
Later in the afternoon, the Senate panel reconvened after the senators attended their weekly party policy lunches and the committee passed the User Fee Bill on 13-9. The next step is considered by the full Senate. A similar bill has already cleared the House.
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