FDA user fee bill marked up by Senate HELP Committee

The Senate Health, Education, Labor and Pensions (HELP) Committee marked up its legislation to reauthorize the FDA user fee agreements, Good Day Bio reported on Wednesday, adding that “drug importation reared its head.”

According to the Committee press release, “HELP held an executive session to consider S. 4348, the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, bipartisan legislation to reauthorize the FDA’s “prescription drug, generic drug, biosimilar, and medical device user fee programs.”

Along with the S.4348, Senate HELP marked up four other bills during its executive session.

As we wrote last week, reauthorizing FDA user fee agreements “for the for fiscal years 2023 through 2027 would set a $1.15 billion base fee amount for human prescription drugmakers for fiscal 2023 and revamp the FDA’s accelerated approval pathway”

As Committee Chair Patty Murray (D-WA) said in her opening remarks, the it’s “the most comprehensive FDA legislation to come out of the Committee in many years,” allowing the FDA to “provide meaningful oversight.”

Considered must-pass legislation, the FDA user fee reauthorization bill passed out of Committee by 13-9. Next, it will need to clear the Senate floor. The Senate vote is expected in July, with the goal of final passage before September 30, when the current five-year FDA user fee agreement expires.

Drug importation amendment rejected

Sen. Bernie Sanders (I-VT) offered an amendment to the FDA user fee bill that would allow the importation of prescription drugs. According to Bloomberg Law, he said the goal is “to do what the American people want, to significantly reduce the price, the outrageous prices of prescription drugs in America.”

His amendment on importation, Good Day BIO pointed out, “would have expanded upon delicately negotiated and narrowly limited language included in the base bill (Sec. 906) that was intended to prevent relitigating the issue at the markup.”

However, one amendment allowing for widescale drug importation was tabled by a vote of 15-7. Another similar to his Prescription Drug Price Relief Act of 2021 was withdrawn.

During the 40-minute debate on the topic, Ranking Member Richard Burr (R-NC) said, “You want to kill this bill? Do [Sanders’] importation,” citing concerns that when it comes to approving drugs, even other developed countries do not have the same “gold standard” as the U.S. FDA.

“We designed an approval process that is above everybody else in the world. Now, what’s the consequence of being with highest standard? Well, we get things first, we pay a lot more for them,” he said.

As the Senate HELP Committee press release notes, Sen. Burr additionally “highlighted the landmark provisions included in this package to ensure the FDA remains forward-looking and accountable to Americans for years to come.”

Sen. Sanders also offered four amendments related to drug pricing, which did not pass.

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