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. In non-leap years we celebrate on February 28 or March 1. Last Wednesday, the White House hosted its first ever rare disease event.

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FDA Law Blog

FEBRUARY 18, 2025

The discussion of the Agencys expectations of the form and substance of expert witness testimony is a must-read for entities or individuals facing a DEA order to show cause hearing. Notably, this discussion does not cite any prior Agency precedent governing expert testimony standards. In Neumanns Pharmacy, LLC , 90 Fed.

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FDA Law Blog

MAY 19, 2025

For a controlled substance prescription to be effective, that is valid, it must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of their professional practice. By Larry K. Houck Last month the U.S. Attorneys Office, Northern District of Illinois, April 21, 2025. 81, 86, 251. 81, 89, 251.

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FDA Law Blog

FEBRUARY 13, 2025

The final guidance hasnt changed much from the draft guidance with respect to the type of modifications FDA considers applicable for a PCCP and the required components of a PCCP (see our prior blog post on the draft guidance here ). In such cases, performance testing may be conducted again.

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FDA Law Blog

NOVEMBER 6, 2022

Gaulkin — We previously blogged about Pfizer’s copay assistance lawsuit, which sought to challenge HHS’s interpretation of the Federal health care program anti-kickback statute (AKS) and position that the company’s proposed copay assistance program would violate the AKS. By Sophia R. Background.

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FDA Law Blog

MARCH 9, 2023

Attorney’s Offices, and, importantly for readers of this blog, the Civil Division’s Consumer Protection Branch (CPB), will all consistently reward corporations that voluntarily disclose and remediate misconduct. It relies on the Department of Justice to do so, either in the form of CPB or in individual U.S. And, FDA still doesn’t.

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FDA Law Blog

OCTOBER 13, 2024

Designed to incentivize the development of drugs for pediatric rare diseases where such development may not otherwise have occurred, vouchers may be granted for drugs for serious or life-threatening rare diseases where the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years.

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FDA Law Blog

APRIL 10, 2025

federal law enacted in 1967 to promote transparency and accountability in the federal government by granting the public the right to request access to government records, subject to certain exemptions. FOIA is a U.S. In some cases, previously routine postings are delayed or going unpublished altogether.

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FDA Law Blog

MARCH 5, 2024

In granting the Government’s summary judgment motion, the court held that AstraZeneca did not have the requisite standing for the APA arguments because it failed to identify a cognizable injury-in-fact that could be redressed by vacatur of the Guidance. Opinion at 17. see also 42 U.S.C. 1320f-1(e)(1)(A).

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FDA Law Blog

AUGUST 4, 2022

The approval process, pre-approval concerns, product labeling, clinical trials, adverse events reports, patent concerns, and exclusivity – these are all critical aspects in the commercialization process for drugs and biologics that are governed by the FDA. UNDERSTAND the importance of cGMPs to the post-approval regulatory process.

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FDA Law Blog

JANUARY 31, 2022

In addition, the Complaint alleges inappropriate dispensing to numerous individuals, multiple DEA recordkeeping violations, improper alteration of prescriptions, and violations Texas law and federal corresponding responsibility obligations required of pharmacists that dispense opioid prescriptions.

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FDA Law Blog

JANUARY 6, 2022

220 and was described on HP&M’s blog here. C) the amount billed to or received from, in part or in whole, the health care benefit program from the individuals referred to a particular recovery home, clinical treatment facility, or laboratory. EKRA is codified at 18 U.S.C. § 18 U.S.C. § 24(b) (emphasis added). 18 U.S.C. §

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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. Medicare or Medicaid). OIG reviews non-safe harbored arrangements on a case-by-case basis. In contrast to its decision in United States v. Polin , 194 F.3d 3d 863 (7th Cir.

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FDA Law Blog

AUGUST 8, 2024

Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals. 21 U.S.C. §

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FDA Law Blog

JUNE 12, 2023

PFI expressed some of its frustration with the current state of regulation of pet food by individual states in its comments on the Center for Veterinary Medicine (CVM) Virtual Public Meeting FDA and the AAFCO Animal Feed Ingredient Definition Process. Enforcement for these regulations also occurs both by federal and state officials.”

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FDA Law Blog

JANUARY 31, 2023

patient advocates and those in Congress (both members and their staffs) who marched and worked to create this new law and make it work. Untold numbers of researchers in academia and in industry. Investors who back this kind of longshot research when many others would say “smart money” should go where the biggest markets are. Act on that.

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FDA Law Blog

JANUARY 6, 2022

220 and was described on HP&M’s blog here. C) the amount billed to or received from, in part or in whole, the health care benefit program from the individuals referred to a particular recovery home, clinical treatment facility, or laboratory. EKRA is codified at 18 U.S.C. § 18 U.S.C. § 24(b) (emphasis added). 18 U.S.C. §

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FDA Law Blog

NOVEMBER 6, 2023

Our knowledge of the laws and regulations governing drugs, medical devices, foods, dietary supplements, and cosmetics is unparalleled in breadth and depth. Due to our broad bench of expertise, the firm is well equipped to defend companies against government enforcement actions and advise clients on necessary compliance efforts.

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FDA Law Blog

FEBRUARY 27, 2023

In an erratum filed to the deposition of an official previously self-identified as the Chief FOIA Officer, the government stated that the individual was in fact, not the Chief FOIA Officer for DEA but Chief of the FOIA/PA Unit at DEA. Merrick Garland, et. al , Case No. 4:2022-cv-02396 S.D.

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FDA Law Blog

JUNE 27, 2024

The government’s expert testified that any red flag associated with a controlled substance prescription must be resolved and that resolution documented before dispensing. By Larry K. Coconut Grove Pharmacy; Decision and Order, 89 Fed. 50,372 , 50,377 (June 13, 2024). make a record of its resolution, assuming it is resolvable.”

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FDA Law Blog

NOVEMBER 2, 2023

These standards would be developed outside the Federal government, leveraging the expertise of the private sector. It finalized a draft guidance published in 2022. Although fairly short and light on substance, it has the potential to reshape the industry in ways that are sorely needed.

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FDA Law Blog

OCTOBER 10, 2022

You can find our preliminary blog post on the release of this guidance here , and our blog posts on the draft CDS guidances here and here. The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains to Clinical Decision Support (CDS) software functions.

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FDA Law Blog

SEPTEMBER 6, 2022

Although a sponsor of an individual patient expanded access trial may only recover direct costs associated with making the drug available, a sponsor of an intermediate-size patient population expanded access IND, or a treatment IND may also recover administrative costs directly associated with the expanded access use.

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FDA Law Blog

JUNE 16, 2023

The statute confuses the issue by providing that “every individual transaction in violation of [the excessive price increase prohibition] is considered a separate violation,” making it unclear whether this is a per-day or per-transaction penalty, and, if the latter, what the transaction is. Is it an increase in AWP/SWP? Best price?

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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.

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The Clinical Problem Solvers

OCTOBER 11, 2021

individual bias or bigotry that leads to a failure to sell a home to a person of color) and personal choices ( e.g. Black people prefer to live among other Black people) is referred to as de facto segregation. These gaps are not a product of lifestyle choices, biology or individual behaviors.

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ABIM

JUNE 24, 2025

Visit the ABIM Blog for reports of prior meetings. Gertz, MD, MACP, Chair, ABIM Hematology Board The Hematology Board , which meets twice a year and is responsible for oversight of ABIM policy and assessment in the specialty, held its spring meeting on May 2, 2025. The following is a summary of the spring meeting.

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FDA Law Blog

FEBRUARY 7, 2024

Gilbert — Last week, DEA and DOJ announced a $59 million civil penalty settlement with eBay related to the failure to comply with Controlled Substances Act (CSA) requirements for identifying purchasers, maintaining records, and filing reports of individuals selling/purchasing pill presses and encapsulating machines.

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FDA Law Blog

NOVEMBER 14, 2021

But like James Bond, companies in the crosshairs of a government investigation have No Time to Die, as they answer to shareholders and fight for corporate survival. To receive such consideration, companies cannot limit disclosure to those individuals believed to be only substantially involved in the criminal conduct.

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FDA Law Blog

NOVEMBER 18, 2021

The tests are very accurate in detecting individuals with a relatively high viral load (symptomatic or not). On the minus side, a rapid antigen test may miss an infected individual with a low viral load (e.g., A follow up laboratory?run run molecular diagnostic (RT?PCR) PCR) test is considered the gold standard for actual diagnosis.

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FDA Law Blog

FEBRUARY 9, 2022

DEA regulations state that a pharmacist has a corresponding responsibility not to fill a prescription unless it is issued for a “legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” Holiday CVS, 77 Fed. at 62,341; see Jones Total Healthcare Pharmacy, L.L.C. 27, 2010).

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FDA Law Blog

MARCH 15, 2023

See Government Accountability Office, “ GAO-06-724 Mammography: Current Nationwide Capacity Is Adequate, but Access Problems May Exist in Certain Locations ” (July 2006). Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.” Your breast tissue is not dense.

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FDA Law Blog

APRIL 8, 2024

What about government factors that cause drug shortages? What the White Paper does not adequately address is whether there are any government-controlled factors that also cause drug shortages. In Section I.A, surgical masks, gloves) versus medical devices that represent large capital expenditures (e.g., surgical robots, MRIs)?

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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. FDA will consider if technologies and device features “address unmet needs in these populations” when evaluating criterion one.

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GeriPal

JANUARY 11, 2024

Summary Transcript Summary Four percent of deaths in Canada are due to Medical Assistance in Dying (MAID). Four percent. The number of people who have used MAID in Canada since it was legalized in 2016 has increased year on year from about 1,000 people in the first year to over 13,000 people in 2022. It is the slippery slope made real. Oh my gosh.

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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. Best Price Stacking We previously blogged about the 4 th Circuit Court of Appeals decision in United States Ex Rel. 1396r-8(b)(3)(B). 1396r-8(b)(3)(B). Sheldon, v.

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FDA Law Blog

SEPTEMBER 6, 2021

Teva case, that the statutory provisions governing patent infringement, specifically induced infringement, do not address carve-outs. The catch is, as we have learned from the GSK v. Until recently, there hasn’t been a need for such a safe harbor, as Courts have not found inducement to infringe in this context, but the GSK v.

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