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Home » Topics » Regulatory » FTC

FTC
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PBM practices a threat to future of biosimilars, FTC, DOJ told

July 14, 2025
By Mari Serebrov
No Comments
Once again, U.S. legislative reforms to rein in pharmacy benefit manager (PBM) business practices missed a ride to finally becoming law. This time, they were kicked out of the Trump administration’s budget reconciliation bill that was signed into law July 4. House Resolution 1, as first passed in the lower chamber, included a few PBM reforms, but they were deleted from the Senate version that ultimately became law because the parliamentarian ruled they didn’t meet the restrictions placed on reconciliation measures.
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Gavel and FTC logo

Xlear presses court to force FTC to drop substantiation requirement

June 25, 2025
By Mark McCarty
Xlear Inc., of Salt Lake City filed a petition in U.S. district court that could terminate the Federal Trade Commission’s practice of demanding substantiation of health care claims.
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Gavel and FTC logo

Xlear presses court to force FTC to drop substantiation requirement

June 24, 2025
By Mark McCarty
Xlear Inc., of Salt Lake City filed a petition in U.S. district court that could terminate the Federal Trade Commission’s practice of demanding substantiation of health care claims.
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Gavel and FTC logo

FTC active again in enforcement of contact lens rule

June 4, 2025
By Mark McCarty
The U.S. Federal Trade Commission said it sent letters to 37 contact lens prescribers reminding them a failure to automatically provide patients with a prescription can result in fines of more than $53,000 per violation.
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FDA Orange Book

Trump DOJ proposes less intrusive corporate prosecution

May 30, 2025
By Mark McCarty
The U.S. Department of Justice is reshuffling its enforcement focus for the coming three years per a May 12 memo attributed to Matthew Galeotti, director of the department’s criminal division. Galeotti said federal attorneys should avoid prosecutorial adventurism in an effort to strike what he described as “an appropriate balance” between enforcement and “unnecessary burdens on American enterprise.”
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Jorge A. Goldstein at Bio Korea 2025
Bio Korea 2025

US legal issues to track in pharma, biotech

May 13, 2025
By Marian (YoonJee) Chu
No Comments
Ongoing policy issues in the U.S., including the Inflation Reduction Act and recent proposals under President Donald Trump’s administration, have wide ranging implications for the global biopharmaceutical industry, speakers at Bio Korea 2025 said May 8, including a heightened need for all biotechs to draft regulatory strategies.
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Illustration of Won currency, graph, up arrows

Korea pharma stocks rally; Celltrion welcomes US drug pricing

May 13, 2025
By Marian (YoonJee) Chu
No Comments
Korean pharmaceutical stocks rose across the board May 13, a day after U.S. President Donald Trump signed off on the most favored nation executive order, a drug pricing policy expected to benefit biosimilar makers in the U.S., according to Celltrion Inc.
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Jorge A. Goldstein at Bio Korea 2025

US legal issues to track in pharma, biotech: Bio Korea 2025

May 8, 2025
By Marian (YoonJee) Chu
No Comments
Ongoing policy issues in the U.S., including the Inflation Reduction Act and recent proposals under President Donald Trump’s administration, have wide ranging implications for the global biopharmaceutical industry, speakers at Bio Korea 2025 said May 8, including a heightened need for all biotechs to draft regulatory strategies.
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US flag, gavel, book

DOJ rolls out task force for review of burdensome regulation

April 25, 2025
By Mark McCarty
The U.S. Department of Justice recently announced the formation of a task force that will advocate the roll-back of regulations that affect a wide swath of sectors of the American economy. Health care is one of the areas of interest for the task force, which will examine state as well as federal regulations.
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No more ‘fox guarding the henhouse’ under new state PBM law

April 22, 2025
By Mari Serebrov
Tired of waiting for the U.S. Congress to get around to making meaningful reforms to pharmacy benefit manager (PBM) practices, states are beginning to take the matter into their own hands. Arkansas recently became the first state to pass a law stopping PBMs, their affiliates or their parent companies from acting as a "fox guarding the henhouse" by being both a price setter and price taker, as the legislation puts it.
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