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Home » Topics » Regulatory » Legislation

Legislation
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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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Drug vials

Industry could feel fallout of Pfizer vaccine scrutiny

July 3, 2025
By Mari Serebrov
No Comments
In subpoenaing a former Pfizer Inc. official to appear before the U.S. House Judiciary Committee July 22, Judiciary Chair Jim Jordan, R-Ohio, signaled legislative steps Congress may take in response to allegations that Pfizer slow-walked its COVID-19 vaccine development in 2020 so the trial results wouldn’t have to be disclosed until after the presidential election.
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Drug vials

Industry could feel fallout of Pfizer vaccine scrutiny

July 2, 2025
By Mari Serebrov
No Comments
In subpoenaing a former Pfizer Inc. official to appear before the U.S. House Judiciary Committee July 22, Judiciary Chair Jim Jordan, R-Ohio, signaled legislative steps Congress may take in response to allegations that Pfizer slow-walked its COVID-19 vaccine development in 2020 so the trial results wouldn’t have to be disclosed until after the presidential election.
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FDA icons

FDA scrutinizing trials sending US patient cells to China

June 24, 2025
By Mari Serebrov
No Comments
Using informed consent to do what Congress couldn’t, the U.S. FDA is flexing its regulatory authority to halt clinical trials that involve sending cells from American patients to China or other adversarial nations for genetic engineering and subsequent infusion back into the patient.
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FDA icons

FDA scrutinizing trials sending US patient cells to China

June 20, 2025
By Mari Serebrov
No Comments
Using informed consent to do what Congress couldn’t, the U.S. FDA is flexing its regulatory authority to halt clinical trials that involve sending cells from American patients to China or other adversarial nations for genetic engineering and subsequent infusion back into the patient.
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Empty conference room

Vaccines meeting to go on in wake of ACIP demolition

June 10, 2025
By Mari Serebrov
No Comments
Despite the June 9 gutting of the U.S. CDC’s Advisory Committee for Immunization Practices, the Department of Health and Human Services said the committee’s June 25-27 meeting will continue as scheduled. But a new panel has yet to be named, and typically ACIP members have a lot of behind-the-scenes work to do before a meeting.
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Pills arranged in dollar sign

US threat of most-favored-nation Rx pricing intensifies

May 15, 2025
By Mari Serebrov
No Comments
Recognizing the potential legal challenges to U.S. President Donald Trump’s executive order calling for most-favored-nation (MFN) prescription drug pricing and the limits of that order, several congressional Democrats introduced a bill in both the House and Senate May 14 that could make MFN pricing the law of the land and extend it to both government health programs and private insurance.
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US lawmakers call for action in addressing PBM practices

May 13, 2025
By Mari Serebrov
No Comments
In a continuing déjà vu, the Senate Judiciary Committee held yet another hearing May 13 on pharmacy benefit managers (PBMs), focusing on a lack of transparency.
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U.S. Capitol building, Washington D.C.

Congress poised to revisit two legislative proposals for patents

May 7, 2025
By Mark McCarty
Legislators in Washington again are considering a pair of bills that would affect how patents are obtained and sustained including the Patent Eligibility Restoration Act of 2025. This would constitute a big win for companies in the life sciences thanks to provisions that clarify just what is and is not eligible for patent protection.
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Exterior of NIH Vaccine Research Center

Senate hearing: US biomedical research at a crossroads

April 30, 2025
By Mari Serebrov
If the April 30 hearing on biomedical research before the U.S. Senate Appropriations Committee is any indication, the Trump administration could face a big challenge if it tries to cut more than 40% of the NIH’s budget in fiscal 2026 as proposed and slap a 15% cap on indirect costs.
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