FDA Law Blog

OCTOBER 8, 2023

As a reminder, back in February 2023, HPM blogged about DEA’s two proposed rules for prescribing (1) controlled substances generally and (2) for buprenorphine use in opioid treatment. DEA next hosted Telemedicine Listening Sessions on September 12 and 13, 2023, for which it receive over 180 requests to present. 69,879, 69,880 (Oct.

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FDA Law Blog

NOVEMBER 30, 2022

These CIP equipment qualification reports were provided to the FDA in support of its PAS and PAI to approve the new facility. As readers of this blog well know, there is no private right of action to enforce the FDCA. 3729) quit tam suit, alleging that Grifols USA, Grifols Biologicals, Grifols, S.A.,

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FDA Law Blog

FEBRUARY 27, 2025

Meanwhile, Annex 2, which provides guidance on pragmatic and decentralized clinical trials as well as trials incorporating real-world data, is expected to be finalized by ICH later in 2025. The guideline expands its focus on data governance and clearly defines the roles and responsibilities of sponsors, investigators, and service providers.

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FDA Law Blog

APRIL 6, 2025

For nearly two decades, Dr. Lowy provided leadership across a range of important therapeutic areas, including general endocrinology, pain/opioids, cardiology, neurology, and psychiatry. We are excited by Naomis strong passion for solving complex regulatory issues and ensuring patient stakeholders have a voice in the drug development process.

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FDA Law Blog

SEPTEMBER 28, 2021

Richardson — On September 24, 2021, the owner of a pharmacy in Puerto Rico pleaded guilty to participating in a felony conspiracy to convert government property and to commit health care fraud in connection with the illegal vaccination of minors between the ages of 7 to 11 with the Pfizer-BioNTech COVID-19 vaccine. By Kalie E.

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FDA Law Blog

FEBRUARY 20, 2023

This case was the latest example of government regulators punishing a company that refused to live up to its promises of consumer data protection. That’s a good list of the kinds of things that most consumers really do not want their digital medical services provider to do with their sensitive personal information.

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FDA Law Blog

JUNE 28, 2022

21-5261, 597 U.S. _ (2022), the Supreme Court ruled that the government must prove — beyond a reasonable doubt — that a prescriber knew or intended that a prescription was not lawful in order to subject that prescriber to criminal penalties under the federal Controlled Substances Act (CSA). Gilbert & Karla L. United States, No.

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FDA Law Blog

JANUARY 18, 2022

In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ). This guidance document is still in effect today. products intended for medical purposes).

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FDA Law Blog

JUNE 30, 2022

As the drug distribution industry is well aware, and as blogged about here , on February 4, 2022, FDA published its long-awaited proposed rule titled “ National Standards for the Licensure of Wholesale Drug Distributors and Third-party Logistic Providers ” (87 Fed. 2) State regulation of third-party logistics providers.

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FDA Law Blog

JANUARY 18, 2023

By Faraz Siddiqui — Last week, the Centers for Medicare & Medicaid Services (CMS) released a memorandum on how it intends to implement the Medicare Drug Price Negotiation Program, passed under the Inflation Reduction Act (IRA) (see our blog post and slide deck on IRA). The memorandum also introduced the Program’s spanking new logo.

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FDA Law Blog

JANUARY 30, 2025

As the DOJ FOIA Guide explains in its introduction : The United States Supreme Court has explained that [t]he basic purpose of [the] FOIA is to ensure an informed citizenry, vital to the functioning of a democratic society, needed to check against corruption and to hold the governors accountable to the governed. 552(a)(4)(B). 552(a)(4)(B).

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FDA Law Blog

FEBRUARY 6, 2024

We’ve blogged previously on the troubles FDA has faced ramping up its foreign inspections program after the pandemic. Mr. Claud was joined in his testimony by Mary Denigan-Macauley , a Director for Health Care at the Government Accountability Office (GAO) and Dinesh Thakur. FDA was invited to attend but did not.

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FDA Law Blog

JANUARY 15, 2024

Koblitz — You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. Clissold & Sara W. FDA originally set the PMTA deadline as August 8, 2022, but a district court in Maryland ordered FDA to shorten it.

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ABIM

MAY 18, 2025

This burden of the disease is being felt by patients and healthcare providers. Worse yet, patients may avoid speaking up, even with their own providers, while suffering silently in pain. The Rising Incidence of IBD in the U.S. and Globally IBD is no longer a rare diagnosis. It is now a growing global health issue. In the U.S.,

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FDA Law Blog

OCTOBER 4, 2023

According to the court, the Constitution guarantees no right to conduct business with the government, so the consequences of that participation can be “conditioned by regulation” without being considered unconstitutional. As such, that statute was unjust, confiscatory and violated their constitutional due process rights. Order at 24.

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FDA Law Blog

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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FDA Law Blog

MAY 31, 2023

The government, while opposing the stay, stated it was willing to enter settlement discussions. Neither the CSA nor regulations promulgated by DEA provide any deadline for issuing a Final Order and Decision. According to that Order, Morris & Dickson had requested a stay of the Final Decision to renew settlement negotiations.

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FDA Law Blog

AUGUST 15, 2021

FDA has now issued a final rule governing how intended use of a distributed product is to be determined. Shapiro — A determination of “intended use” is fundamental to FDA’s regulation of drugs and medical devices. It is a primary basis for determining if an article is regulated by FDA at all, and if so, what regulatory requirements apply.

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FDA Law Blog

JULY 13, 2022

If the biosimilar has not been licensed and marketed within the approved delay period (either 1 or 2 years depending on likelihood of licensure), the manufacturer of the biological product must pay a rebate to the government for the lost savings due to the delay. Koblitz & Kurt R. Each product is limited to two years of delay.

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FDA Law Blog

OCTOBER 26, 2022

In the interim, the issue has reared its head again in FDA’s recently issued guidance for industry, titled Refusal of Inspection by a Foreign Food Establishment or Foreign Government. . FDA’s view is stated in the agency’s Investigation Operations Manual, and it is one with which a number of practitioners disagree.

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FDA Law Blog

JANUARY 18, 2022

In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ). This guidance document is still in effect today. products intended for medical purposes).

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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

JULY 8, 2024

The Seventh amendment provides that in “suits at common law, where the value in controversy shall exceed twenty dollars, the right of trial by jury shall be preserved, and no fact tried by a jury, shall be otherwise reexamined in any court of the United States.” Jarkesy. This is where the majority and dissent differ.

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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. Sorenson follows the Fifth Circuits decision last year in United States v. Marchetti, 96 F.4th Marchetti, 96 F.4th Medicare or Medicaid).

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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

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. 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.

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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 ). FDA provides definitions for the three datasets.

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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. Many federal agencies do have policies that provide a safe harbor for voluntary disclosures, but FDA does not.

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FDA Law Blog

JANUARY 4, 2024

The American Conference Institute (“ACI”) will be hosting the go-to forum for critical updates on OTC regulation and enforcement, monograph reform, ACNU and advertising essentials… and FDA Law Blog readers can get a discount. FDA Law Blog is a conference media partner for this event. The discount code is: S10-826-826L24.S.

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FDA Law Blog

DECEMBER 7, 2023

In his conference keynote address , Arun Rao—the Deputy Assistant Attorney General for DOJ’s Consumer Protection Branch—provided an overview of DOJ’s year in FDA enforcement. We’ve blogged on VSDs previously here and here , as the application of the VSD for FDA-regulated industry has been vexing.

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FDA Law Blog

MAY 4, 2025

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. Houck Drug Enforcement Administration (DEA) civil monetary settlements involving listed chemicals that do not include pseudoephedrine are rare.

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FDA Law Blog

NOVEMBER 15, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — In our last blog post , we advised medical device companies to consider applying to FDA’s Small Business Program to help with the noticeably higher user fees for FY2023. In this blog post, we provide a primer on user fees and the Small Business Program.

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FDA Law Blog

NOVEMBER 10, 2022

Unlike virtually all DEA/DOJ civil settlements that we are aware of, the government recently announced a settlement not with a DEA registrant but with non-registered retail inventory service providers. Then something novel comes along. While no registrant is a party to the settlement, as the U.S. 29, 2022), at [link]. 1301.71.

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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

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FDA Law Blog

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. The program, however, has always had a scheduled sunset date.

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FDA Law Blog

AUGUST 23, 2021

The PhRMA Code is updated periodically to reflect changes in industry norms or, as is likely the case with the latest revision, in response to political pressure or increased scrutiny from the federal government. Department of Health and Human Services (OIG) (see our blog post on this Special Fraud Alert here ).

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FDA Law Blog

JUNE 15, 2022

Kirschenbaum — In 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule to significantly decrease the rate the government will reimburse 340B hospitals in 2018 for outpatient prescription drugs from average sales price (“ASP”) plus 6% to ASP minus 22.5%. By Faraz Siddiqui & Alan M. 52494 (Nov. Becerra, No.

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