FDA Law Blog

OCTOBER 8, 2023

Palmer — On Friday, October 6, 2023, DEA announced a second extension of telemedicine flexibilities concerning the prescribing of controlled substances, which were originally set to expire after the end of the COVID-19 pandemic emergency. By Karla L. comments on the two proposed rules.

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FDA Law Blog

MAY 19, 2025

86, 72703 (December 22, 2021), DEA emphasized in the Gulf Med decision that prescribing [r]ed flags are circumstances surrounding a prescription that cause a pharmacist to take pause, including signs of diversion or the potential for patient harm. Patients filling prescriptions at the same time at multiple pharmacies. 81, 86, 251.

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FDA Law Blog

JANUARY 5, 2023

Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well. By John W.M.

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FDA Law Blog

JULY 17, 2022

An example of such a drug is a single-use vial of an injectable cancer drug that is dosed based upon weight, and therefore might not be entirely used for a lighter weight patient. On July 8, as part of its annual physician fee schedule update for 2023, CMS issued a proposed regulation to implement the new refund. million).

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FDA Law Blog

MARCH 1, 2023

Brevig, Senior Regulatory Device and Biologics Expert — In January 2023, FDA published a paper summarizing its lessons learned from two pilot Quality Management Maturity (QMM) Pilot Programs, such as best practices for conducting QMM assessments and developing the QMM scoring system. By Holly N.

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FDA Law Blog

MARCH 24, 2024

The 340B contract pharmacy dispute involves several manufacturers who are refusing to provide 340B discounts to covered entities if they requested 340B drugs to be delivered to, and dispensed from, a network of contract pharmacies. McClain , No. 22-3675, 2024 U.S. LEXIS 5840 (8th Cir. 2024) at 13 (“Decision”). Decision at 8-9.

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FDA Law Blog

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” Tobolowsky & Richard A. It finalized a draft guidance published in 2022.

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FDA Law Blog

JUNE 27, 2024

After issuing an Order to Show Cause and Immediate Suspension of Registration in September 2022, and an administrative hearing in March 2023, DEA adopted the hearing Administrative Law Judge’s (“ALJ’s”) Recommended Decision to revoke Coconut Grove’s registration based on the public interest factors of 21 U.S.C. 72,694, 72,703 (Dec.

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Medical Xpress

JUNE 16, 2025

This region governs essential behaviors like the circadian clock, sleep, energy balance , and feeding. The content is provided for information purposes only. But technical limitations have made it hard to understand how neurons in this area form functional circuits."

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ABIM

MAY 30, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Lieske, MD , raised concerns about how new government policies may affect international medical graduates and health equity work at ABIM. Community Practice in ABIM Governance* Erica N.

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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. She happened to focus on some specific for-profit hospice providers. Eric: Great.

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FDA Law Blog

OCTOBER 17, 2023

This 2022 draft guidance proposed that certain non-addictive medical products for pain or addiction treatment could be eligible for breakthrough designation, aligning with the Agency’s obligations under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act.

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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. The patient case. I think the theme is more saving someone’s life and the regret that follows.

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FDA Law Blog

NOVEMBER 21, 2024

DEA notes in the Federal Register notice that it received over 38,000 comments to its 2023 proposed rules (35,454 for the general telemedicine flexibilities proposed rule and 2,915 for the buprenorphine telemedicine flexibilities proposed rule), and held two days of public listening sessions addressing industry comments.

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FDA Law Blog

APRIL 8, 2024

MRAP would provide oversight of an accreditation body which would conduct assessments—paid for by the manufacturer—based on criteria developed by the MRAP. Unfortunately, the White Paper does not provide further analysis on the generic sterile injectables and instead refers back to FDA’s analysis from 2013-2017. surgical robots, MRIs)?

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FDA Law Blog

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. The preamble provides an example of reporting an incorrect baseline AMP, which reduces the unit rebate amount. Sheldon, v.

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GeriPal

MARCH 6, 2025

link] PEACH Good Wishes Program A program that provides meaningful gifts for unhoused individuals who are terminally ill. So we did a podcast on aging and homelessness with Margot Kushel in 2023. They can’t believe it, but we come back again and again and again gently to provide that support. We just hired a nurse.

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FDA Law Blog

AUGUST 14, 2022

The negotiations will result in a Maximum Fair Price (“MFP”) that the manufacturer must make available to providers furnishing the drug under Medicare Part B or pharmacies dispensing the drug under Part D. The same will be required under state Medicaid and CHIP programs by October 1, 2023.

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GeriPal

AUGUST 15, 2024

Ongoing reports from patients about anti-Asian hate experiences Should clinicians screen for Anti-Asian hate? This question, while providing an opportunity to talk about direct and indirect experiences, can be asked of all patients, and opens the door to conversations about anti-semitism, islamophobia, or anti-Black racism.

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FDA Law Blog

FEBRUARY 11, 2024

The three letters together provide the range of actions DEA may take: no rescheduling from schedule I (former drug officials), rescheduling to schedule III (Democratic state attorneys general), or descheduling altogether (Democratic senators). (We We blogged on the December 5, 2023, letter from six Democratic governors to President Biden).

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GeriPal

APRIL 20, 2023

Today we talk with Margot Kushel about how we got here, including: That sense of powerlessness as a clinician when you “fix up” a patient in the hospital, only to discharge them to the street knowing things will fall apart. It was in the mid-nineties, and about half of the patients that we cared for in the inpatient service were homeless.

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GeriPal

DECEMBER 21, 2023

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.” Everything.

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Common Sense Family Doctor

APRIL 25, 2025

While I'm grateful for subspecialists who alleviate pain, rescue patients who are unable to breathe on their own, manage complicated fractures, and replace worn-out hips and knees, the gap between the number of family doctors we need and the number we have keeps getting wider. This is where the federal government must step up.

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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. Many organizations, such as the American Medical Association Journal of Ethics, recommend against documenting immigration status in medical records.

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FDA Law Blog

AUGUST 3, 2021

Department of Health and Human Services in December 2020 to prevent Medicare Part D and Medicaid Managed Care plans from receiving rebates from manufacturers unless the rebates are passed through to pharmacies to reduce patient out-of-pocket expenses. We previously explained the rebate rule and its likely impact on patients and payors here.

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Physician's Weekly

JUNE 26, 2025

He directed the patients to seek local help. While it’s possible that Nath’s patients suffered covid vaccine injuries, Marks said, their symptoms were so varied it was hard to characterize a possible syndrome. His clinical study was ending. But, Dressen said, there wasn’t any. Kennedy Jr. forced him out in May.

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FDA Law Blog

SEPTEMBER 14, 2021

This bill, which addresses numerous areas of the economy, public health, and government regulation, includes Subtitle E, Drug Pricing. Under all of these programs, patient co-insurance would be calculated based on the MFP so that patients receive the benefit of that price. Subtitle E is a slightly modified version of H.R.

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Physician's Weekly

JUNE 13, 2025

Also, the bill would curtail taxes that nearly every state levies on providers to help draw down billions in additional federal money, which generally leads to more money for hospitals. But about half of rural hospitals are still independent, Topchik said, and struggle with a perennial collision of low patient volume and high fixed costs.

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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

Clinicians could care for patients across state lines, could prescribe opioids without in person visits, could bill at higher rates for telemedicine than previous to the pandemic. Many patients benefited, not only those isolating due to covid, but also patients in rural areas, patients who are homebound, and many others.

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FDA Law Blog

MAY 23, 2025

During the first Trump Administration, the 10-for-1 Rule seemed to be more in name only when it came to FDA, whereas this administration seems more intent on its deregulatory approach, so we expect it to have more of an impact on FDA governance this time around. specific patient populations, disease states, and procedures).

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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

The episodes turned both women into advocates for patients and spurred research that made American health care safer. Haskell, of Columbia, South Carolina, has done research and helped write AHRQ-published surveys and guidebooks on patient engagement for hospitals. It also has published tools and guidelines to enhance patient safety.

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Physicians News Digest

APRIL 17, 2025

Harm to HIV, Vaccine Studies The NIH, with its nearly $48 billion annual budget, is the largest public funder of biomedical research in the world, awarding nearly 59,000 grants in the 2023 fiscal year. In November 2023, he told an anti-vaccine group, “I’m gonna say to NIH scientists, ‘God bless you all. Thank you for public service.

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