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Green Practice News: May 2025

My Green Doctor

In This Issue : Why Renewable Energy Belongs in Every Clinic Medical Waste: One Model for Improvement OnTrack with your Sustainability Goals? Powering Health, Protecting the Planet – Why Renewable Energy Belongs in Every Clinic Healthcare professionals have always been trusted voices on public health.

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Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

FDA Law

Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. That court granted summary judgment to the government on the APA claim and rejected Pfizer’s narrower reading of the AKS, which would require an element of “corrupt” intent to impose AKS liability.

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FDA Publishes De Novo Classification Final Rule with Few Changes from the Proposed Rule

FDA Law

Only a year later, in 1977, FDA promulgated regulations governing 510(k) reviews (21 C.F.R. Yet, all this time, this process lacked implementing regulations governing the process and the criteria for approval. The regulatory uncertainty has ill?befitted Part 807, Subpart E). FDCA § 513(f)(5). 515(d)(2)(C).

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The MAHA Assessment’s Implications: Drugs (Part One)

FDA Law

Ordinarily, a public health initiative of such magnitude would have been governed by a transparent multi-step process featuring public meetings and drawing on external scientific expertise. In other words, as you read this, the Assessments findings and recommendations are getting baked into federal government policy, for better or worse.

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‘MAHA Report’ Calls for Fighting Chronic Disease, but Trump and Kennedy Have Yanked Funding

Physician's Weekly

But the administration is seeking to cut government funding that could serve as a counterweight. Trump’s budget proposes spending $500 million “to tackle priority activities to Make America Healthy Again,” including $260 million for his new Administration for a Healthy America to address the “chronic illness epidemic.”