FDA Law Blog

JUNE 12, 2024

HP&M) seeks to add an experienced attorney (7+ years) to our government discount program and price reporting practice. Hyman, Phelps & McNamara, P.C. (HP&M)

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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). In January 2024, the U.S. VANDA PHARMACEUTICALS, INC.

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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

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

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. A complete agenda is available here.

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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

JULY 22, 2024

FDA Law Blog readers receive a 10% discount off the tuition fee (promo code D10-999-FDA25 ). s John W.M. Claud will be speaking at the conference in a session titled “Crafting Your Safety Blueprint for Adverse Events and Recalls under MoCRA.” You can register for the conference here.

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FDA Law Blog

MAY 15, 2025

FDA Law Blog readers are offered a discount of 10% off the registration price. The discount code is 25HYMAN10. You can access conference information and register for the event here.

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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. Learn More Subscribe to the ABIM Blog to stay on top of the latest news.

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FDA Law Blog

SEPTEMBER 30, 2021

The District Court spent 30 pages of its 38 page opinion detailing exactly why the Court has standing to adjudicate the aggrieved Plaintiffs’ claims, which standing arguments were briefed in excruciating detail by the government.

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FDA Law Blog

DECEMBER 4, 2023

The government asserted additional allegations that are outside our scope. Prescribing Red Flags The government alleged that from at least 2017 to April 2021 Defendants knowingly filled controlled substance prescriptions “that raised obvious ’red flags’ of potential abuse or diversion.” Zarzamora Press Release. Complaint ¶ 55.

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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 7, 2025

Karst will speak at a session, titled Hitting the Books: Examining Orange and Purple Book Delisting from a Patent Prosecutorial Perspective, along with co-presenters Kim Braslow (Senior Director, IP and Government Affairs, AstraZeneca) and Nicole Woods (Associate Vice President, Assistant General Patent Counsel, Eli Lilly and Company).

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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). United States, No. appropriately licensed, etc.)

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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

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

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

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. §

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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

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 appealed to the Second Circuit. Further, “there is little utility in comparing the language of the BIS to that of the AKS.”.

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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. The Alert described several factors that could potentially violate the antikickback statute.

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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. . That refusal is executed administratively, with no need to involve lawyers or judges, and the results can be highly disruptive. See here and here.

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FDA Law Blog

MARCH 4, 2024

Her deep understanding of FDA administrative actions alongside her proactive approach in helping companies prevent or respond to government investigations, makes her a pivotal voice in discussions on regulatory compliance. FDA Law Blog readers can use the discount code 24SPKR150 for reduced registration fees.

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FDA Law Blog

MARCH 12, 2023

These government measures included granting temporary exemptions from certain FDA and DEA legal requirements. The COVID-19 pandemic emergency forced federal regulators to take extraordinary measures to ensure that patients were permitted continued access to important medicines.

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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

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

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 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

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

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 ).

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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

FEBRUARY 27, 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

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.

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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. That means that the Criminal Division, 94 U.S. Monaco said was national transparency and consistency.

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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). While the information in the SIUU Guidance is a welcome departure from FDA’s more restrictive approaches under GRP, it may not go far enough.

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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. And a look at FDA’s Data Dashboard for Inspections reveals that the Agency is returning to pre-pandemic numbers.

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FDA Law Blog

AUGUST 4, 2022

District Court Judges from District of Delaware, District of New Jersey, Eastern District of Pennsylvania, government representatives from key agencies, in-house counsel and law firms. Register today ( here ) and save 10% with the FDA Law Blog promo code: D10-999-FDALAWBLOG. Along with this year’s 2022 co-chairs, join U.S.

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