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Home » Topics » Regulatory » Legislation

Legislation
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Prescription pad

Legislation would authorize AI to write prescriptions

March 19, 2025
By Mark McCarty
The unrelenting pressure on medical practice in the U.S. has sparked some innovations, but a legislative innovation is now in the works that would fundamentally shift how at least some drugs are prescribed. The Healthy Technology Act of 2025 (H.R. 238) would allow AI and machine learning algorithms to write prescriptions for pharmaceuticals, although the lack of co-sponsors for H.R. 238 suggests that this bill is not ready for prime time just yet.
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Prescription pad

Legislation would authorize AI to write prescriptions

March 18, 2025
By Mark McCarty
The unrelenting pressure on medical practice in the U.S. has sparked some innovations, but a legislative innovation is now in the works that would fundamentally shift how at least some drugs are prescribed. The Healthy Technology Act of 2025 (H.R. 238) would allow AI and machine learning algorithms to write prescriptions for pharmaceuticals, although the lack of co-sponsors for H.R. 238 suggests that this bill is not ready for prime time just yet.
Read More
Pills spilling out of prescription bottle

Ending ‘pill penalty’ challenges sacred cow status of IRA

March 11, 2025
By Mari Serebrov
Getting the Ensuring Pathways to Innovative Cures (EPIC) Act through the U.S. Congress to do away with the “pill penalty” in the Medicare drug price negotiations could require an epic effort, given the current politically fueled atmosphere on the Hill. With the Inflation Reduction Act (IRA), which created the negotiations, considered a signature achievement of the Biden administration, the negotiations have become, for many lawmakers, almost a sacred cow that can’t be touched. If anything, some of them want to expand the negotiations to more drugs and to the commercial market.
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Pills arranged in dollar sign

Bill could have epic impact on drugs selected for negotiations

March 10, 2025
By Mari Serebrov
Several drugs already selected for Medicare price negotiations, including Novo Nordisk A/S’ mega-blockbuster diabetes/weight-loss franchise, could see up to a three-year reprieve if a bipartisan bill recently introduced in the U.S. House and Senate becomes law.
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Bipartisan PBM reforms back on the congressional table

Feb. 26, 2025
By Mari Serebrov
The U.S. Congress is turning its attention, once again, to bipartisan pharmacy benefit manager (PBM) reforms, after efforts to rein in PBM practices died with the 118th Congress. With an eye on finally getting them passed, the House Energy and Commerce Committee kicked off the process with a Feb. 26 hearing that was supposed to be focused on the reform legislation the committee approved last year and follow-on legislation to rein in harmful PBM practices.
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Efforts revived to stem flow of US funding for China R&D

Feb. 11, 2025
By Mari Serebrov
The Biosecure Act may have died with the 118th U.S. Congress, but efforts to stop U.S. government funding of R&D in China are alive and well. Rep. Claudia Tenney, R-N.Y., introduced the Stop Funding our Adversaries Act in the House Feb. 7 to prohibit direct and indirect federal funding of research in China or entities owned by China.
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Critics of Super Bowl Rx ad call for new playbook

Feb. 10, 2025
By Mari Serebrov
Amid a strengthening offensive against direct-to-consumer drug ads, two senators flagged a Super Bowl ad promoting compounded drugs as part of the company’s attack on the U.S. weight-loss industry that it said was built to keep Americans “sick and stuck.”
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Efforts revived to stem flow of US funding for China R&D

Feb. 10, 2025
By Mari Serebrov
The Biosecure Act may have died with the 118th U.S. Congress, but efforts to stop U.S. government funding of R&D in China are alive and well. Rep. Claudia Tenney, R-N.Y., introduced the Stop Funding our Adversaries Act in the House Feb. 7 to prohibit direct and indirect federal funding of research in China or entities owned by China.
Read More
Tablets on conveyor belt

Rx manufacturers caught between 340B, IRA requirements

Jan. 30, 2025
By Mari Serebrov
One of the uncertainties in the changing of the guard in both the U.S. administration and Congress is the future of 340B reforms. Now the Inflation Reduction Act makes reforms more critical than ever, as it requires manufacturers of drugs selected for price negotiations to certify that they’re giving 340B entities the lowest price, be it the 340B discount or the maximum fair price set by the CMS as part of the negotiation process.
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US flag and HHS logo

Mum’s the word at US health agencies awaiting new leadership

Jan. 23, 2025
By Mari Serebrov
With key officials yet to be confirmed at the U.S. Department of Health and Human Services, the acting secretary imposed an immediate pause throughout the department on publicly issuing any document or communication without first getting it approved by a presidential appointee.
Read More
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