FDA Law

OCTOBER 1, 2024

District Court for the District of Columbia (“DDC”) against FDA alleging that the Agency’s structure of NDA review is unconstitutional (by our count the 31st Vanda litigation against FDA or another government entity in the last five years, including appeals). In January 2024, the U.S. VANDA PHARMACEUTICALS, INC.

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California Academy of Family Physicians (CAFP)

MAY 14, 2025

Key Health Care Budget Proposals: Proposed Medi-Cal Cuts and Enrollment Changes Medi-Cal, California’s Medicaid program, is typically funded through a partnership between the state and the federal government. To fill that gap, California has chosen to use state-only funds to provide certain Medi-Cal benefits to undocumented Californians.

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FDA Law

NOVEMBER 27, 2023

According to the government, these companies knew as early as 2012 that their dehumidifiers were defective, in that they could overheat and catch fire. The government charged these individuals with conspiracy (18 U.S.C. § Per DOJ, this is the first-ever criminal prosecution of individuals for failure to report under the CPSA.

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FDA Law

DECEMBER 23, 2024

As we mentioned in our blog post, this first sunset date was originally in September, but was given a brief reprieve until December 20, 2024, as part of a continuing resolution to keep the government funded until that date. As December 20 approached, there was a need for another continuing resolution to keep the government funded.

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Permanente Medicine

MAY 22, 2025

In the 2024 National Committee for Quality Assurance’s annual report , Kaiser Permanente’s commercial and Medicare plans rated highest or tied for highest for overall treatment, prevention, equity, and patient experience among competitors in every geographic region served. To learn more about Permanente Medicine, visit permanente.org.

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FDA Law

OCTOBER 13, 2024

A very important aspect of the program is that it costs FDA, and the government, no additional dollars, though we do not wish to minimize the additional resources a priority review demands over the standard review that such an application might otherwise receive. Notably, it was reauthorized in 2016 (until 2020) and in 2020 (until 2024).

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FDA Law

MAY 15, 2024

On April 29, the FDA issued their long-awaited, controversial Final Rule governing the oversight of laboratory developed tests ( LDTs ). This new rule will dramatically alter the LDT regulatory landscape, while at the same time requiring significant operational changes and posing strategic challenges for many LDTs.

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FDA Law

MARCH 3, 2024

3558 ) on January 25, 2024. This proposed legislation should be of interest to any biotechnology companies that want to do business with the federal government in the future. Scope Part 2 —Is reimbursement under Medicaid a grant of funds by the federal government, such that they are governed by the Act?

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FDA Law

OCTOBER 8, 2023

That First Temporary Rule also provided a one-year grace period, through November 11, 2024, for any practitioner-patient telemedicine relationships established on or before November 11, 2023. DEA also announced that it is working to promulgate these new telemedicine standards or safeguards by the fall of 2024. 69,879, 69,880 (Oct.

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Physician's Weekly

JUNE 24, 2025

has long disparaged certain vaccines, calling them unsafe and saying that the government officials who regulate them are compromised and corrupt. As data from the 2024-25 season becomes available, researchers hope to determine whether the vaccine will remain a one-and-done, or whether immunity will require repeated vaccination.

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ABIM

APRIL 24, 2025

In 2024, 82% of ABIM Board Certified rheumatologists due for an assessment opted for the LKA over the traditional, 10-year MOC exam. Community Practice in ABIM Governance* Dr. Johnson led a discussion with the Rheumatology Board on community practice in rheumatology to create a more inclusive understanding of its role and scope.

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FDA Law

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. Photo from February 28, 2024, White House Rare Disease event (from left to right: Frank Sasinowski, Christina Hochul, Paul Melmeyer)

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FDA Law

JANUARY 4, 2024

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution.

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FDA Law

JUNE 2, 2025

Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. District Court for the Eastern District of Texass decision vacating the LDT Rule lapsed without the government doing so. By Steven J. Gonzalez & Allyson B.

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FDA Law

MARCH 4, 2024

This essential event for regulatory professionals in the biopharmaceutical and medical device industries will take place March 12-13, 2024, in Arlington, VA. (HP&M), is pleased to announce that Director Anne Walsh will be speaking at the DIA Advertising and Promotion Regulatory Affairs Conference. Before joining HP&M, Ms.

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FDA Law

JANUARY 8, 2024

Claud — As the calendar turned to 2024, we came across the usual end-of year looks back and projections ahead. Moreover, it requires not only an understanding of what the laws say, but how what the government would be expected to do in the future based on the regulatory compliance history. By John W.M.

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FDA Law

MARCH 5, 2024

Also, the IRA would subject Farxiga to the negotiated maximum fair price for the entirety of 2026 if no generic version entered the market before August 1, 2024, even if a generic drug later enters the market before or during 2026. at least one drug” has been approved and marketed. 16 June 2023) Eliquis Novartis D.N.J. (1

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FDA Law

DECEMBER 11, 2024

Date: Wednesday, December 11, 2024 Time: 12:00 PM to 1:15 PM ESTfda Presenters: Alan Kirschenbaum , Director, HPM Jennifer Lospinoso, Managing Director, Riparian LLC Lynn Buhl, Managing Director, Riparian LLC Please click here to register. (See our post on this rule here.)

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FDA Law

DECEMBER 9, 2024

Date: Wednesday, December 11, 2024 Time: 12:00 PM to 1:15 PM EST Presenters: Alan Kirschenbaum , Director, HPM Jennifer Lospinoso, Managing Director, Riparian LLC Lynn Buhl, Managing Director, Riparian LLC Please click here to register. (See our post on this rule here.)

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FDA Law

OCTOBER 7, 2024

2117 (2024). 27, 2024), the plaintiff H&P challenged an FDA administrative complaint assessing a civil money penalty of $20,678 for H&P sale of an electronic cigarette without FDA authorization. Constitution’s Seventh Amendment right to a jury trial. See SEC v Jarkesy , 144 S. In Huff and Puffers v. 8:24-cfv-02110 (C.D.

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FDA Law

MARCH 24, 2024

On March 12, 2024, a three-judge panel of the Eighth Circuit affirmed. 22-3675, 2024 U.S. 2024) at 13 (“Decision”). The federal government has long maintained that state law offers an additional, and important, layer of consumer protection that complements federal regulation. & Mfrs. McClain , No. LEXIS 5840 (8th Cir.

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FDA Law

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. 2024) , which affirmed Marchettis conviction for receiving illegal kickbacks but determined that most of his actions did not violate the AKS. Mallory , 988 F.3d

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FDA Law

JULY 17, 2022

For example, the October 1, 2025 report will contain claims for 2Q 2024 through 1Q 2025, plus lagged claims from 2Q 2023 through 1Q 2024. Each report will also contain late-received (lagged) claims for the period covered by the previous year’s report.

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FDA Law

MARCH 29, 2024

In 2022, the Government Accountability Office reported that FDA needed to improve its foreign inspection program. Complete numbers for 2023 and 2024 are not available, but it appears that FDA was only able to complete 537 BIMO inspections in 2022. But gaps still remain. The vast majority are for drugs.

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FDA Law

FEBRUARY 11, 2025

To help our readers learn more about these rebates before they confront the first invoices, weve prepared a memo summarizing CMS final rule on the two Medicare inflation rebate programs, which was issued on December 9, 2024. The memo is available here.

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FDA Law

JANUARY 18, 2023

Recall that CMS is required to negotiate and publish the 2016 maximum fair price for 10 high expenditure, single source Part D drugs by September 1, 2024. Offer and Counteroffer Data Exchange: CMS and manufacturers will exchange offers and counteroffers during negotiation (February to August of 2024 for 2026 prices).

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FDA Law

APRIL 21, 2024

Government—was that, despite having missed the statutory 60-day filing deadline, the patent was granted a PTE due to a change in the law created by Section 37 of the Leahy-Smith America Invents Act (“AIA”) ( Pub. The way that matter ended up—after touching all three branches of the U.S. Patent Nos.

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FDA Law

MAY 30, 2024

District Court and won, prompting a government appeal to the D.C. Six states have enacted contract pharmacy protections into law: Kansas , Maryland , Mississippi , and West Virginia in 2024, Louisiana in 2023, and Arkansas in 2021. We have blogged about this controversy in previous posts (see e.g., here and here ).

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FDA Law

FEBRUARY 4, 2024

Mullen — On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs). By Steven J. Gonzalez & Gail H.

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FDA Law

DECEMBER 7, 2023

Panelists from CPB, FDA, and the Federal Trade Commission (FTC) all amplified the enduring government policy that they expect companies in the food and drug space have robust and legitimate compliance programs. As that may develop, the 2024 edition of this conference will be worth coming back for.

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FDA Law

JANUARY 11, 2024

Notably, the purpose of the statute seemed to govern much of FDA’s interpretation. The first commercial marketing of each, according to the biosimilar patent settlement agreement, was July 1, 2023, which would render the FIE expiration date July 1, 2024. This all sounds complicated, I know.

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FDA Law

JANUARY 12, 2025

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. FDAs December 5, 2024 draft guidance on accelerated approvals appears intended to cover each of these topics even if not by dividing them precisely along those lines.

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FDA Law

JUNE 27, 2024

50,372 , 50,377 (June 13, 2024). The Government alleged that Coconut Grove violated numerous federal and state controlled substance laws. Coconut Grove Pharmacy; Decision and Order, 89 Fed. 21 U.S.C. § 823(g)(1)(B), (D). at 50,376. “A 21 C.F.R. §§ 1306.04(a), a), 1306.06.

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FDA Law

JUNE 16, 2023

Initial appointments to both the Board and advisory council will occur by January 1, 2024. Prescription Drug Affordability Board The law also establishes a nine-member Prescription Drug Affordability Board and an 18-member stakeholder advisory council to provide advice to the Board on drug cost issues.

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FDA Law

DECEMBER 21, 2023

Both are celebrating their 75th anniversaries in 2024. 2024 brings a host of Hyman, Phelps & McNamara, P.C. 2024 brings a host of Hyman, Phelps & McNamara, P.C. (“HPM”) In other exciting news — in 2024 FDLI will be getting a make-over! What do Gene Autry’s Rudolph the Red-Nosed Reindeer and FDLI have in common?

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ABIM

JUNE 11, 2025

In 2024, 75% of infectious disease physicians who chose an assessment opted for the LKA over the traditional, 10-year MOC exam. Community Practice in ABIM Governance* Erica N. IDSA has also been hosting member forums to maintain public access to evidence-based guidelines no longer available through government institutions.

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ABIM

JUNE 4, 2025

In 2024, 77% of eligible ABIM Board Certified endocrinologists who chose an assessment opted for the LKA over the traditional, 10-year MOC exam. Community Practice in ABIM Governance* Erica N. Some data, such as exam pass rates and resident and fellow workforce trends , are publicly available on ABIM’s website.)

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