FDA Law Blog

DECEMBER 23, 2024

As we blogged recently, the program has had scheduled sunset dates from its very beginning, which have been repeatedly extended. As December 20 approached, there was a need for another continuing resolution to keep the government funded. Therefore, there remains hope that Congress could still act to extend the program.

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FDA Law Blog

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. We do not see the release of this Warning Letter as directly related to the LDT litigation, however.

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FDA Law Blog

AUGUST 26, 2021

To hold a corporation liable for these actions, the government must establish that the corporate agent’s actions (i) were within the scope of his duties and (ii) were intended, at least in part, to benefit the corporation. In light of the above, the government generally resists the notion that an organization is a victim of its own employees.

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FDA Law Blog

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). Or consider Vanda’s lawsuit filed in the U.S. In January 2024, the U.S.

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FDA Law Blog

NOVEMBER 30, 2022

As readers of this blog well know, there is no private right of action to enforce the FDCA. The Realtor argued that the government healthcare programs require that drugs not be “adulterated,” which means that Grifols’ manufacturing processes must comply with all applicable GMPs.

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FDA Law Blog

SEPTEMBER 15, 2023

On September 18-20, Informa Connect will hold its annual #MDRPSummit in Chicago (and via livestream) to discuss the complex, ever-evolving laws and regulations in the government pricing and price reporting space. FDA Law Blog readers can receive a 10% discount off the conference registration price.

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FDA Law Blog

DECEMBER 4, 2023

The government asserted additional allegations that are outside our scope. On October 10th, based on ability to pay, the U.S. District Court for the Western District of Texas imposed a $275,000 civil penalty on Zarzamora Healthcare LLC, in San Antonio, and its pharmacist-owner. 11, 2023 ( DOJ Press Release ). Zarzamora Press Release.

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ABIM

APRIL 24, 2025

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

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FDA Law Blog

JULY 22, 2024

FDA Law Blog readers receive a 10% discount off the tuition fee (promo code D10-999-FDA25 ). The American Conference Institute (“ACI”) is holding its 2nd West Coast Editionof its Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products from September 25-26 at the Le Meridien Delfina, Santa Monica, California.

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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

MARCH 29, 2024

Many have noted that FDA has been slow to recover We’ve blogged before on FDA’s post-pandemic inspection work, writing about the resumption of both good manufacturing practice (GMP) and bioresearch monitoring (BIMO) inspections. In 2022, the Government Accountability Office reported that FDA needed to improve its foreign inspection program.

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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. The catalogue of resources, guidances, and other regulatory materials for the DHCE is growing, as we have noted in prior blog posts.

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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

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.

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FDA Law Blog

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. § What led to this conviction? It is a long story that started more than a decade ago. and Gree USA Inc.

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FDA Law Blog

OCTOBER 3, 2022

For example, the government closely scrutinizes speaker programs or trainings that involve lavish venues or meals and free alcohol, invite attendees with no legitimate business reason to attend, and present little substantive information to them. This lawsuit was brought to the U.S. See United States ex rel. Bawduniak v. Biogen Idec, Inc. ,

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FDA Law Blog

MARCH 22, 2023

We will continue to follow the developments, but for today’s blog, focus on what’s at stake—in short, massive amounts of damages and penalties. In a recent trial, a jury verdict finding $43M in single damages has, according to the government , resulted in $490M in statutorily mandated liability.

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FDA Law Blog

APRIL 2, 2025

Some highlights from the opinion are quoted below (citations and internal quotations omitted): As the Government correctly points out, the FDCA does not impose mandatory GRAS notification on manufacturers or require FDA to review industry GRAS conclusions in advance of marketing. Cue Loper Bright , which weve blogged about here and here.

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FDA Law Blog

SEPTEMBER 1, 2021

But the scope of regulatory diligence and its application to post-acquisition activities has broader implications, namely whether the government will hold the Buyer responsible, either criminally , civilly , or administratively , for the regulatory issues it inherited through the acquisition. emphasis added).

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FDA Law Blog

AUGUST 4, 2022

That court granted summary judgment to the government on the APA claim and rejected Pfizer’s narrower reading of the AKS, which would require an element of “corrupt” intent to impose AKS liability. Pfizer, Inc. Department of Health and Human Services et al. July 25, 2022. Pfizer appealed to the Second Circuit.

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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

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

APRIL 24, 2024

or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or tribal governments or communities.” . ; Our readers will recall that the rule went to OMB on March 1 for its review.

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FDA Law Blog

JULY 30, 2024

Women in Government and Judiciary Roundtable. We heard multiple speakers acknowledge that Loper Bright will invite more challenges to government regulation and the need for federal agencies to shore up their rules and regulations to protect past actions and reduce the ripple effects for regulated entities.

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FDA Law Blog

MAY 31, 2023

The government, while opposing the stay, stated it was willing to enter settlement discussions. In the second notice the DEA Administrator is issuing an Order granting the 90-day effective date from publication of the Final Decision. Thus, the DEA Administrator has given the parties 90 days to work something out.

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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

MARCH 3, 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? House of Representatives ( H.B.

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FDA Law Blog

FEBRUARY 27, 2025

The guideline expands its focus on data governance and clearly defines the roles and responsibilities of sponsors, investigators, and service providers. Below, we explore some of the key themes seen in the changes. As stakeholders begin implementing R3, many questions remain regarding its practical application.

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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. See here and here.

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ABIM

MAY 18, 2025

On this World IBD Day, I’m reflecting not just on the growing global impact of IBD, but on how cultural identity, disparities and stigma influence the patient experience in ways we can’t ignore. 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

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

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).

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FDA Law Blog

DECEMBER 22, 2022

That, of course, is reserved for the practice of medicine, and FDA does not govern the practice of medicine. By Jeffrey N. Gibbs & Sara W. Koblitz — Back in June, when Congress was negotiating the User Fee Acts, FDA asked Congress to add in some provisions reversing several lawsuits that it had just lost.

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FDA Law Blog

SEPTEMBER 22, 2022

While the authors did a yeoman’s job of combing through the criminal cases to identify what they view as a “handful” of cases and call for increased use of the Park doctrine, we at the FDA Law Blog respectfully disagree. The JAMA editorial notes that there are few Park cases for two primary reasons: [The government] may lead.

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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

OCTOBER 24, 2023

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP). However, there’s a clear shift in FDA’s approach that is noticeable from the title of the Draft Guidance, alone.

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FDA Law Blog

NOVEMBER 6, 2023

A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April 2021 that it would start using them as an alternative to on-site inspections. Significantly, FDA agrees that the RIEs may be conducted in lieu of an inspection.

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