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Home » Topics » Regulatory » Legislation

Legislation
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Magnifying glass atop paperwork

IPRs not the US patent killer once feared, but problems remain

Aug. 13, 2024
By Mari Serebrov
With inter partes reviews (IPR) once feared as patent killers, the mere fact that an IPR petition challenging a drug or device patent had been filed with the U.S. Patent and Trademark Office was enough to send a company’s stock tumbling. That initial fear has “kind of ebbed and flowed” over the past 12 years as the patent reviews established by the America Invents Act have come of age, Aziz Burgy, a partner and patent litigator at Axinn, Veltrop & Harkrider LLP, told BioWorld.
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Pressure building for bipartisan 340B reforms

Aug. 7, 2024
By Mari Serebrov
With time running out on the 118th U.S. Congress, a group of lawmakers is urging the leadership of the House Energy and Commerce Committee to consider a bipartisan path forward on strengthening the 340B drug discount program.
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Prescription drug bottle, pills shaped in $ sign

House Oversight hearing cuts through PBM blame game with warning

July 23, 2024
By Mari Serebrov
Noting that the median list price of new drugs that entered the U.S. market last year hit $300,000, senior officials of the three biggest pharmacy benefit managers (PBMs) in the country once again denied responsibility for those prices as they testified before the House Oversight Committee July 23 in the third hearing the committee has held on PBM practices.
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Magnifying glass on wooden table

Loper Bright bringing more scrutiny, uncertainty to US agencies

July 19, 2024
By Mari Serebrov
As the U.S. Congress continues to pass laws that require federal agencies to issue rules to implement new statutory provisions, a group of lawmakers is reminding the agencies that it will be looking over their shoulders to ensure they don’t stray beyond the scope of the law or overstep their authority.
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Congress looking for ‘simple solutions’ to Rx pricing quandary

July 18, 2024
By Mari Serebrov
The bill the U.S. Senate passed to prune biologic patent thickets could be among the first in a legislative thicket aimed at prescription drug prices to make it through the Senate before the year ends.
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US Senate passes effort to prune biologic patent thickets

July 15, 2024
By Mari Serebrov
A bipartisan bill aimed at limiting patent thickets on biologics moved a step closer to law July 11 when the Senate passed it with unanimous consent in an unexpected vote that came more than one-and-a-half years after the Judiciary Committee reported it favorably to the Senate floor. The Affordable Prescriptions for Patients Act, S. 150, which would limit the type and number of patents that can be litigated under the Biologics Price Competition and Innovation Act (BPCIA), now awaits House action.
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Is enforcement enough to address PBM issues?

July 11, 2024
By Mari Serebrov
Just a day after the U.S. FTC released an interim report on harmful pharmacy benefit manager (PBM) practices and appeared before a House subcommittee that encouraged the commissioners to take enforcement action, the agency reportedly was preparing to file suit against the country’s three largest PBMs over their practices in negotiating insulin and other drug prices.
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Few surprises in FTC’s interim report on PBM practices

July 9, 2024
By Mari Serebrov
The redacted interim report released July 9 of an ongoing FTC investigation into pharmacy benefit managers (PBMs) shed little, if any, new insight into PBM practices and how they impact availability and pricing of prescription drugs in the U.S.
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Novo CEO joins growing list of Rx execs bowing to HELP Committee

June 25, 2024
By Mari Serebrov
Novo Nordisk A/S’ CEO Lars Jørgensen is set to be the next executive in the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee’s pharma parade of shame. HELP Chair Bernie Sanders (I-Vt.) announced June 24 that Jørgensen will testify before the committee Sept. 24 about his company’s U.S. pricing of its blockbuster semaglutide drugs, Ozempic and Wegovy.
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Biosecure Act misses first congressional ride

June 18, 2024
By Mari Serebrov
The Biosecure Act missed its first chance at a congressional ride June 11 when the U.S. House Rules Committee didn’t include it, as many had expected, on the list of potential riders the House will consider for its version of the National Defense Authorization Act, a must-pass defense spending bill for fiscal 2025. But that doesn’t mean the bill will be stranded by the wayside.
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