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Home » Topics » Regulatory » Legislation

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Senate IRA hearing mix of praise, scathing reviews

Sep. 17, 2024
By Mari Serebrov
Two tales of one law were told Sept. 17 as the U.S. Senate Finance Committee discussed the successes and failures of the health care provisions included in the Inflation Reduction Act (IRA) as members looked toward different sequels.
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Cityscape, US flag and virtual lock

US Biosecure Act a step closer to becoming law

Sep. 17, 2024
By Mari Serebrov
With an eye on shutting down national security threats and securing American innovation, the U.S. House overwhelmingly passed the Biosecure Act Sept. 9 with a vote of 306-81. The next stop on the bill’s path to enactment is a Senate vote and, if it gets that, then on to the president’s desk.
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Senators send stern message to US FDA on animal testing

Sep. 16, 2024
By Mari Serebrov
While it’s called the FDA Modernization Act (FDAMA) 3.0, the short bipartisan bill introduced in the U.S. Senate Sept. 15 is basically a message to the FDA: “The move away from animal testing in FDAMA 2.0 wasn’t a congressional suggestion. It’s a mandate, so get it done.”
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Cityscape, US flag and virtual lock

US Biosecure Act a step closer to becoming law

Sep. 10, 2024
By Mari Serebrov
With an eye on shutting down national security threats and securing American innovation, the U.S. House overwhelmingly passed the Biosecure Act Sept. 9 with a vote of 306-81. The next stop on the bill’s path to enactment is a Senate vote and, if it gets that, then on to the president’s desk.
Read More
Chinese flag on flagpole

US lawmakers flag clinical trials with ties to China military

Aug. 27, 2024
By Mari Serebrov
Drug and device sponsors conducting clinical trials in China to support U.S. FDA approval may want to reconsider their choice of trial sites, as trials conducted at hospitals and clinics affiliated with China’s military or in the Xinjiang Uyghur Autonomous Region could be in for increased scrutiny.
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Chinese flag on flagpole

US lawmakers flag clinical trials with ties to China military

Aug. 21, 2024
By Mari Serebrov
Drug and device sponsors conducting clinical trials in China to support U.S. FDA approval may want to reconsider their choice of trial sites, as trials conducted at hospitals and clinics affiliated with China’s military or in the Xinjiang Uyghur Autonomous Region could be in for increased scrutiny.
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Doctor and patient consultation

Patient perspective: Cost of Medicare negotiations not in dollars

Aug. 20, 2024
By Mari Serebrov
While the Biden administration continues applauding the savings it claims will be delivered by the first round of Medicare negotiations, many U.S. patients and their families are worried about the cost of the biopharma price-setting program – a cost they measure not in dollars and cents, but in worsening illness and lives that may be lost to a downturn in innovation and an upturn in barriers to access.
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Piggy bank filled with dollar coins

GSK, Prasco pressured to drop price of pediatric inhaler

Aug. 15, 2024
By Mari Serebrov
Boehringer Ingelheim GmbH’s and Astrazeneca plc’s implementation of a $35 monthly U.S. price cap on inhalers for asthma and chronic obstructive pulmonary disease is adding to the pressure on Prasco Laboratories and GSK plc to follow suit with the pricing of an authorized generic of GSK’s Flovent (fluticasone propionate) inhaler.
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GSK, Prasco pressured to drop price of pediatric inhaler

Aug. 14, 2024
Boehringer Ingelheim GmbH’s and Astrazeneca plc’s implementation of a $35 monthly U.S. price cap on inhalers for asthma and chronic obstructive pulmonary disease is adding to the pressure on Prasco Laboratories and GSK plc to follow suit with the pricing of an authorized generic of GSK’s Flovent (fluticasone propionate) inhaler.
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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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