FDA Law Blog

MARCH 24, 2024

PhRMA argued that Congress established the 340B drug discount program, imposed ceilings on prices drugmakers may charge certain healthcare facilities, specified what those facilities are, and provided compliance and enforcement mechanisms for manufacturers and covered entities. As such, the court held that FDCA does not preempt Act 1103.

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FDA Law Blog

MAY 26, 2022

And that brings us to FDA’s draft legislation to make reality one of the Legislative Proposals the Agency included in its Fiscal Year 2023 Budget Justification. healthcare system.” They may exist on another Earth in the Multiverse, but bringing them into our “Exclusivity Earth-616” would result in an incursion. In other words.

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FDA Law Blog

MARCH 30, 2022

Earlier this week, FDA issued its Fiscal Year 2023 Budget Justification and related documents. Among the various documents, a document titled “ Executive Summary of FY 2023 Legislative Proposals ” caught our attention. healthcare system. But before we get back to “the Good” again, let’s take a look at “the Bad” and “the Ugly”.

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FDA Law Blog

JUNE 27, 2024

District Court for the District of Texas on Zarzamora Healthcare LLC for repeatedly dispensing opioids and other controlled substances “by filling prescriptions while ignoring red flags.” The Government alleged that Coconut Grove violated numerous federal and state controlled substance laws. 21 U.S.C. § 823(g)(1)(B), (D).

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FDA Law Blog

OCTOBER 17, 2023

In October 2022, FDA released the draft guidance entitled “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Healthcare,” as previously discussed in our blog.

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GeriPal

MARCH 6, 2025

-Alex End Well Talk [link] Resources on the PEACH Program Program Review Paper A recent publication in Longwoods Healthcare Quarterly reviewing the PEACH model. So we did a podcast on aging and homelessness with Margot Kushel in 2023. The raw reality is that the many of the people we care for do not trust the healthcare system.

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GeriPal

MARCH 24, 2023

JAMA IM 2023 A shout-out to my NPR episode on 1A titled the “State of Hospice Care” DISCLAIMER While we filmed in Montreal during the Annual Assembly, all opinions expressed in this podcast are independent of AAHPM and HPNA, or the Annual Assembly. JAMA IM 2021 Hospice Acquisitions by Profit-Driven Private Equity Firms. JAMA Health Forum.

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GeriPal

SEPTEMBER 29, 2022

Eric and I are working on it…maybe by 2023? . Eric: You got this depot in the high layer, so absorption is really governed by the microcirculation to that stratum corneum and skin… Alex: We’re going deep here – Eric said “stratum corneum. And yes, this would be a great one for CME. AlexSmithMD. Transcript.

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GeriPal

SEPTEMBER 5, 2024

And Bill Andereck is still haunted by the decision he made to have the police break down the door to rescue his patient who attempted suicide in the 1980s, as detailed in this essay in the Cambridge Quarterly of HealthCare Ethics. Louise 05:02 Yes, well, I don’t know about 2024, but in 2023, yes, it could happen.

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FDA Law Blog

FEBRUARY 11, 2024

We blogged on the December 5, 2023, letter from six Democratic governors to President Biden). The regulated cannabis marketplace brings in billions of dollars in revenue into state and federal governments, with predictions that cannabis sales will exceed $53 billion by 2027. Letter to U.S.

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GeriPal

APRIL 20, 2023

In the United States in 2023, the truth of the matter is you don’t need very many individual risk factors to become homeless. So they need mainstream healthcare, and they need housing support. In what moral universe is a federal government deeply subsidizing my housing and not subsidizing that of my patients?

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GeriPal

AUGUST 15, 2024

It’s both institutionalized racism where there are policies and practices by corporations, by government that create inequality. Really, across the board, there was a spike, and it seemed to have, seems to have come down from 2022 to 2023. We do talk about healthcare policy. As far as the numbers, pretty significantly.

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GeriPal

DECEMBER 21, 2023

Eric: And looking back at that time, what do you think the healthcare system could have done to help with that? We have all of these models that are out there that have proven benefits for patients, for caregivers, and some of them for healthcare systems as far as saving money for, let’s say, Medicare. Why do we need to do more?

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Common Sense Family Doctor

APRIL 25, 2025

Dr. Rochelle Walensky, who directed the Centers for Disease Control and Prevention (CDC) from 2021 to 2023, calls the current state of affairs an "evidence emergency" : There is no more urgent research need than addressing the health of the workforce that is charged primarily with caring for the people of its nation.

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The Clinical Problem Solvers

MAY 2, 2023

[link] CPSolvers: Antiracism in Medicine Series Episode 21 – Psychosocial and Cultural Considerations for Providing Healthcare to Immigrant and Refugee Populations Show Notes by Kiersten T. April 25, 2023 Show Transcript Download CPSolvers App here RLRCPSOLVERS

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FDA Law Blog

JUNE 1, 2025

Government Accountability Office (GAO) published a report finding that, for the years 2016-2018, the pharmaceutical industry spent on average for a sample of 553 drug products approximately $6 billion annually on DTC advertisements, with a significant portion of this spending allocated to television commercials. In 2021, the U.S.

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GeriPal

JULY 20, 2023

See the AAHPM Legislative Action Center [link] Write to the DEA, with guidance from AAHPM’s comments to the DEA March 2023. ” And I could tell you that’s a lot for a government agency to hear. ” Why don’t we say, “All of healthcare is dangerous.” Start with a story as Carly did in her Op Ed.

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FDA Law Blog

MAY 26, 2025

Below, we highlight some of the challenges we would see in the governments attempt to pursue these cases. Attorneys Offices to use the False Claims Act (FCA) to investigate the submission of false claims to federal healthcare programs for non-covered services related to radical gender experimentation. Driehaus , 573 U.S.

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GeriPal

APRIL 17, 2025

Summary Transcript CME Summary I read Farah Stockmans article in the NYT on why attacks on DEI will cost us all , and thought, Yes, and everyone includes harm to our healthcare workforce, our patients, and their families. Now to the federal government that is going way beyond what I think people truly understand. Well played.

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Physicians News Digest

APRIL 3, 2025

On April 1, the Trump administration slashed the organization that supported that research — the Agency for Healthcare Research and Quality, or AHRQ — and fired roughly half of its remaining employees as part of a perplexing reorganization of the federal Health and Human Services Department.

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