FDA Law Blog

MARCH 7, 2024

Led by Annie Kennedy, Everylife’s VP of Government Affairs and Policy, we worked the halls of Congress to educate lawmakers on the pressing needs of the rare disease community. I currently serve as Vice Chair of the Board of the Everylife Foundation. Last Wednesday, the White House hosted its first ever rare disease event.

Government 69

Government Community Specialization Education 69

FDA Law Blog

OCTOBER 24, 2023

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP). The presentation should be accompanied by the reprint and the reprint, itself, must meet the criteria articulated in the SIUU Guidance for reprints.

Clinic 64

Clinic Clinical Practice Provider Utilities 64

FDA Law Blog

FEBRUARY 18, 2025

While on paper the respective credentials of each of the experts would indicate a balance of authority, or maybe even weigh in favor of the pharmacys expert (DEAs expert had prior disciplinary history), the ALJ and DEA Administrator each found the testimony of the governments expert more credible. Whats the take away?

Government 69

Government Specialization Patients IT 69

FDA Law Blog

MAY 4, 2025

1-BOC-Piperidone is a DEA-regulated List 1 chemical while (2-Bromethyl) benzene is on DEAs longstanding, recently updated Special Surveillance List. The government determined that the chemicals had been imported into the U.S. The government alleged that IMC Pro entered into business agreements with companies operating in China.

Manufacturing 52

Manufacturing Government Specialization IT 52

FDA Law Blog

OCTOBER 25, 2021

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. Part 807, Subpart E). In 1986, FDA followed up with the PMA regulations (21 C.F.R. The regulatory uncertainty has ill?befitted

Manufacturing 52

Manufacturing Government Specialization IT 52

FDA Law Blog

DECEMBER 7, 2023

There were too many interesting panels and discussions to mention them all, but presentations about DOJ’s and FDA’s coordination deserve some special mention. We’ve blogged on VSDs previously here and here , as the application of the VSD for FDA-regulated industry has been vexing.

Consulting 52

Consulting Manufacturing Provider Government 52

FDA Law Blog

APRIL 6, 2025

Andrew draws on his government experience investigating and prosecuting violations of the FDC Act, the Controlled Substances Act, the False Claims Act, and other federal healthcare laws to now represent clients facing those issues. During law school, Julie obtained practical litigation and transactional experience.

IT 59

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. The FCA incentivizes whistleblowers to come forward by awarding them a cut of any recovery.

Government 40

Government Patient-Centered Manufacturing IT 40

FDA Law Blog

SEPTEMBER 30, 2022

Kirschenbaum — In November 2020, we blogged about a decision by the Federal District Court of Maryland dismissing a Federal False Claims Act (FCA) qui tam suit alleging that Forest Laboratories knowingly reported inflated best prices under the Medicaid Drug Rebate Program (MDRP), resulting in underpayment of rebates.

Insurance 40

Insurance Manufacturing Government Specialization 40

FDA Law Blog

MAY 3, 2021

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. We will discuss these actions in more detail in later blog. 44,710, 44,716 (July 24, 2020).

Management 52

Management Manufacturing Specialization IT 52

FDA Law Blog

MAY 7, 2025

Two recent cases from the Fifth and Seventh Circuits, however, support the legality of these arrangements in the absence of the government proving certain circumstances. Mallory , 988 F.3d 3d 730 (4th Cir. The case law on commission-based marketing agentsincluding the Sorensen decisionfollow in a similar vein. Marchetti , 96 F.4th

Referral 59

Referral Relationship Government Healthcare 59

FDA Law Blog

JULY 2, 2024

Claud — Among the tools that the government has to enforce the FDC Act is the injunctive power granted by Congress in 21 U.S.C. § While she agreed with the decision here, she did not join in the Court’s decision that the traditional pillars of equity apply in all cases where a special statute provides for injunctive relief.

Provider 52

Provider Government Specialization IT 52

FDA Law Blog

MAY 3, 2021

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. We will discuss these actions in more detail in later blog. 44,710, 44,716 (July 24, 2020).

Management 40

Management Manufacturing Specialization IT 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. DEA regulations require “adequate security” but do not specially require cameras in health care facilities. Department of Justice (“DOJ”), Sovah Health to Pay United States $4.36

Board-Certified 52

Board-Certified Provider Government Management 52

ABIM

JUNE 4, 2025

Visit the ABIM Blog for reports of prior meetings. See the discussion on the Special Consideration IMG (International Medical Graduates) Pilot Pathway below.) Community Practice in ABIM Governance* Erica N. The following is a summary of the spring meeting. or Canada to become eligible for ABIM Board Certification.

Diabetes 52

Diabetes Board-Certified Telehealth Government 52

ABIM

JUNE 11, 2025

Visit the ABIM Blog for reports of prior meetings. Community Practice in ABIM Governance* Erica N. She also sought input on overlapping aspects of community practice across the disciplines of internal medicine to inform ABIM’s recruitment efforts for broad physician representation in governance roles.

Board-Certified 52

Board-Certified Government Community Education 52

ABIM

MAY 30, 2025

Visit the ABIM Blog for reports of prior meetings. 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. The following is a summary of the spring meeting. Siddharta G.

Board-Certified 40

Board-Certified Government Internal Medicine Private Practice 40

FDA Law Blog

MAY 11, 2023

Koblitz — Well, we’re a little late to blogging about this, but the significance of the ongoing Teva v. GSK litigation to Hatch-Waxman aficionados makes this case still ripe for blogging. government in the now-infamous (at least in FDA circles) Teva v. government in the now-infamous (at least in FDA circles) Teva v.

Government 72

Government Manufacturing IT Utilities 72

FDA Law Blog

APRIL 8, 2024

In its report, Drug Shortages: Root Causes and Potential Solutions, FDA explains that the equipment needed to produce sterile injectables is highly specialized and expensive, meaning that in a shortage situation, production capacity cannot be substantially increased without taking the time and expense of procuring and qualifying new equipment.

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

GeriPal

MARCH 16, 2023

We have two authors, books, op-eds, prolific authors, and today’s podcast is a two-part special. Like in pandemic, I wrote a few articles early on and then when I started working for the city and state, I just stopped and partly was the horrible, horrible, horrible things we were seeing and that the government was doing to older people.

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IT Healthcare Professional Healthcare Transportation 105

FDA Law Blog

JUNE 21, 2022

This provision adds nothing substantive to the OTC hearing aid regulatory scheme—it merely tells FDA that it has 30 days from enactment of the user fee legislation to issue its final rules governing OTC hearing aids. Directing FDA to issue rules isn’t out of the ordinary.

IT 52

IT Provider Government Patients 52

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. Radical Transparency.

Manufacturing 59

Manufacturing Specialization IT Provider 59