FDA Law Blog

JANUARY 31, 2023

So when patients led by Abbey Meyer and Marjorie Guthrie (Woody Guthrie’s widow) had championed the 1983 law to create incentives for developing drugs for those with rare conditions, the FDA was excited at this once-in-a-generation new law as this was FDA’s 3ed major drug law in nearly half a century. Abbey Meyers, Marjorie Guthrie, Rep.

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Patients Patient-Centered Government IT 59

FDA Law Blog

APRIL 6, 2025

Naomi Lowy joins HPM as a Principal Drug Regulatory Expert after 18 years at the FDAs Center for Drug Evaluation and Research (CDER), most recently as the Deputy Director, Division of General Endocrinology. We were sad when he left to gain valued experience as a federal prosecutor but are absolutely thrilled and honored to welcome him back.

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IT Nurse Practitioner Patient-Centered Government 59

FDA Law Blog

JUNE 7, 2023

Last week, the Court ruled on a pair of combined cases that potentially impacts many of our blog readers in the pharmaceutical, device, and biologics space that benefit from reimbursements from Federal health care programs. They are entitled to receive one third of any claw back, which can result in multi-million-dollar awards.

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Government Patient-Centered Manufacturing IT 40

FDA Law Blog

JULY 17, 2022

Kirschenbaum — Last November, we blogged about a provision of the Infrastructure Investment and Jobs Act that requires new rebates for discarded amounts of drugs that are covered under Medicare Part B, and that are packaged in a single-dose container or single-use package.

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FDA Law Blog

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. 220 and was described on HP&M’s blog here. EKRA is codified at 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 220(e)(2).

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FDA Law Blog

JANUARY 12, 2025

As such, we will publish a separate blog post focused on confirmatory trials and how FDA is interpreting this key provision of its accelerated approval authority. First, patients may be exposed to safety risks from a drug that subsequently fails to demonstrate clinical benefit.

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Clinic Relationship Provider IT 64

FDA Law Blog

JANUARY 5, 2023

To date, regulatory enforcement litigation focused on actual or imminent patient harm has taken a backseat to cybersecurity as FDA continues to update and implement its oversight framework. Combination products might be part drug, part device, or part software or hardware.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 59

FDA Law Blog

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. 220 and was described on HP&M’s blog here. EKRA is codified at 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 220(e)(2).

Lab Testing 40

Lab Testing Individual Referral Patient-Centered 40

FDA Law Blog

JUNE 22, 2022

This matter is the latest in a recent string of large monetary settlements between the government and health care providers involving employee diversion. It was alleged that other employees administered the medication to patients even after observing signs of tampering, although no patients were reported harmed.

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ABIM

JUNE 11, 2025

Visit the ABIM Blog for reports of prior meetings. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Community Practice in ABIM Governance* Erica N. The following is a summary of the spring meeting.

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ABIM

JUNE 24, 2025

Visit the ABIM Blog for reports of prior meetings. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Community Practice in ABIM Governance* Erica N. The following is a summary of the spring meeting.

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Board-Certified Board-Certified Physicians Government Community 40

GeriPal

JANUARY 11, 2024

In further contrast to the United States, MAID in Canada is almost entirely administered by a clinician, whereas in the United States patients must self administer. Alex: And we’re delighted to welcome Sonu Gaind, who is a Chief of psychiatry and professor at the Sunnybrook Health Sciences Center at the University of Toronto.

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Illness IT Medical Provider 144

FDA Law Blog

FEBRUARY 20, 2025

Given the numerous changes in policy by the Trump administration, there had been much speculation that the government would now take a different position on this Biden-era rule. Interestingly, counsel focused his arguments exclusively on parrying legal attacks, rather than arguing why the rule was necessary to protect patients.

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FDA Law Blog

NOVEMBER 18, 2024

He states, correctly, that PDUFA user fees make up about 75% of the budget for the Center for Drug Evaluation and Research (CDER). Though he did not mention it, there is also a Medical Device User Fee Act (MDUFA), which accounted for approximately 44% of the budget for the Center for Devices and Radiological Health (CDRH) in FY2023.

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FDA Law Blog

SEPTEMBER 13, 2021

Currently, individual Medicare Part D plan sponsors negotiate rebates but the government is explicitly prohibited from interfering in those negotiations. The attraction of the repeal is that Part D negotiations can potentially save the federal government “hundreds of billions of dollars,” as explained in the Plan.

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Manufacturing Supply Chain Patient-Centered Utilities 98