FDA’s Final Guidance on Decentralized Clinical Trials Published

On September 18, 2024, the U.S. Food and Drug Administration (FDA) issued final Guidance on recommendations for conducting decentralized clinical trials (DCTs) for drugs, devices or biological products. Instead of using traditional clinical trial sites, DCTs hold some or all trial activities remotely at locations convenient for trial participants by, for example, using telehealth appointments, outsourcing visits to local healthcare providers, or conducting laboratory tests at outside facilities.

Read the Alert on the Duane Morris LLP website.

FDA’s Latest Draft Guidance on Medical Device PCCPs Incorporates FD&C Act Changes

The U.S. Food and Drug Administration (FDA) recently issued draft Guidance informing medical device manufacturers how to structure a predetermined change control plan (PCCP) to describe appropriate, intended future device modifications. The Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research in consultation with the Center for Drug Evaluation and Research and the Office of Combination Products in the Office of the Commissioner worked together to prepare this Guidance.

Read the full Alert on the Duane Morris LLP website.

House Oversight Committee Gives Pharmacy Benefit Managers Deadline to Correct Congressional Record of Allegedly Fraudulent Statements

On August 28, 2024, the U.S. House Committee on Oversight and Accountability issued letters to executives of three of the nation’s largest pharmacy benefit managers (PBMs), accusing them of providing false testimony before Congress. Each letter outlines the allegedly false statements and the evidence that the statements contradict. They also outline the statutory penalties for perjury before Congress—namely, monetary fines and imprisonment for up to five years. The letters give the PBMs until September 11, 2024, to correct the Congressional Record.

Read the Alert on the Duane Morris LLP website.

Artificial Intelligence in Medtech

Given the vast amounts of data available, including raw measurements, diagnostic information, treatment plans, and regulatory guidelines, the biomedical technologies sector stands to gain immensely from artificial intelligence (AI), particularly machine learning (ML).

ML, at its core, learns from training datasets to identify patterns, which can then be applied to new input data to make direct inferences. For instance, if specific body scans frequently result in a particular diagnosis, ML can be used to quickly provide that diagnosis when similar scans are encountered, thus aiding in disease diagnosis.

Read the full article by Duane Morris partner Agatha H. Liu, PhD on the MD+DI website

Patent Primogeniture: Obviousness-Type Double Patenting Immunity for First-Filed, First-Issued and Later-Expiring Patent in a Family

Recently, the relationship and intersection between obviousness-type double patenting (ODP) and any awarded Patent Term Adjustment (PTA) and/or Patent Term Extension (PTE) has received significant attention. The United States Court of Appeals for the Federal Circuit held in In re Cellect, 81 F.4th 1216 (Fed. Cir. 2023), that PTA and PTE, being codified in separate statutes, are treated differently for the purposes of determining the requisite expiration dates in an ODP analysis.

The Federal Circuit’s recent holding in Allergan USA, Inc. v. MSN Laboratories Private Ltd., No. 2024-1061, 2024 WL 3763599 (Fed. Cir. Aug. 13, 2024), raises the issue of when a claim can be used as a reference claim in an ODP analysis. In particular, the court addressed the question of whether “a first-filed, first-issued, later-expiring claim [can] be invalidated by a later-filed, later-issued, earlier-expiring reference claim having a common priority date”. Id. at *4.

Read the Alert on the Duane Morris LLP website.

Induced Infringement Suit Against Generic Pharma Revived Despite Skinny Label Compliance

In Amarin Pharma v. Hikma Pharmaceuticals USA (No. 2023-1169), the Federal Circuit recently reversed the District Court of Delaware’s ruling and held that Amarin’s complaint plausibly pleads that Hikma actively induced healthcare providers’ direct infringement, while also indicating that it “may agree with the district court (and Hikma)” that Hikma’s skinny label alone did not, as a matter of law, recommend, encourage or promote any infringing use.

Read the full Alert on the Duane Morris LLP website.

Federal Trade Commission Poised to File Suit Against Pharmacy Benefit Managers Based on Unlawful Medication Pricing

On July 10, 2024, multiple media sources reported that the Federal Trade Commission intends to file suit against the nation’s three largest pharmacy benefit managers over​ allegations of improper pricing in connection with their negotiations with drug manufacturers that dramatically increased prices for consumers and lined the PBMs’ pockets with lucrative “rebates.”

Tp read the full text of this Duane Morris Alert, please visit the firm website.

Doing No Harm but Exporting Without Appropriate License Can Violate Regulations

By Brandon A. Chan, Ph.D., and Brian Goldstein

On June 24, 2024, the Department of Commerce’s Bureau of Industry and Service (BIS) imposed an administrative penalty on Indiana University (IU) as part of a settlement agreement following IU’s discovery and self-disclosure to BIS that its Bloomington Drosophila Stock Center engaged in the export of materials that violated the Export Administration Regulations. IU’s violations stemmed from its export of biological and genetic material without the proper license under the BIS.

The exports at issue involved genetically modified drosophila expressing transgenes that encode a component of the toxin ricin known as ricin toxin A chain. Drosophila, or the fruit fly, is a common model organism in genetic research because of its simple genetic makeup that consists of only four chromosomes and a short life cycle allowing for rapid reproduction for studies. Ricin is a ribosome inactivating protein that halts protein synthesis to produce its toxic effects. The toxin is comprised of two separate protein chains, the ricin toxin A chain and the ricin toxin B chain. By themselves, ricin toxin A chain and ricin toxin B chain are harmless; both components must be present in the form of a heterodimeric complex to exhibit toxicity. However, exports of ricin and its subunits ricin toxin A chain and ricin toxin B chain are regulated under the Australia Group to mitigate against proliferation of chemical and biological weapons, and thus fall under the Commerce Control List.

The Proposed Charging Letter cited 42 export shipments of the genetically modified drosophila classified under Export Classification Control Number (ECCN) 1C353.b.2 (until April 2, 2018) and 1C353.a.3 to countries listed on the Commerce Country Chart under CB Column 1 relating to Chemical and Biological Weapons. Because each destination country was listed under the CB Column 1, pursuant to 15 C.F.R. § 742.2(a)(1)(ii), a license is required for the export of genetic elements (i.e. ECCN 1C353) that encode for toxins and their subunits identified under ECCNs 1C351.d.14 and .15. Ricin is specifically named in ECCN 1C351.d.14. See Commerce Control List, Category 1 – Special Materials and Related Equipment, Chemicals, “Microorganisms” and “Toxins.”

Under the terms of the settlement agreement: i) IU is subject to a suspended denial of its export privileges for ECCNs 1C351, 1C353 and 1C354 for one year; ii) IU must train the appropriate personnel in export compliance; iii) IU must deliver a presentation as to the circumstances of the instant violations and self-disclosure on export controls of biological materials to stock center directors and at the Association of University Export Control Officers conference or another related forum.

The suspended denial of export privileges for ECCNs 1C351, 1C353 and 1C354 may be modified or revoked if IU commits another violation or fails to comply with the terms of the settlement agreement. Revocation of the suspension of the denial would prevent IU from applying for, obtaining or using a license for the export of items under ECCNs 1C351, 1C353 and 1C354; prevent IU from partaking in deals or the handling of items designated as ECCNs 1C351, 1C353 and 1C354; and benefitting from transactions involving items designated as ECCNs 1C351, 1C353 and 1C354.

This recent incident demonstrates the importance of understanding the nature of any exported genetic material despite the genetic material and the encoded material ultimately being harmless. Export of genetic material falling under, currently, ECCN 1C353.a.3, even if the genetic material encodes for a harmless substance, such as ricin toxin A chain, to destination countries listed under the CB Column 1 without the appropriate license is still a violation. Universities, research institutions, stock centers, or other exporters who engage the export of biological and genetic should take heed to understand the background and make up of its exports regardless of whether the genetic material or encoded material is harmless and apply for and obtain the necessary licenses for exporting the material. The last thing a world renowned research university wants is to be accused of engaging in the proliferation of chemical and biological weapons via the export of benign genetic material without the appropriate license.

The full order, terms of the settlement agreement, and Proposed Charging Letter are publicly available from the Department of Commerce.

The Changing Beauty Regulatory Landscape

Duane Morris attorney Kelly Bonner was quoted in an article in WWD on June 25, 2024.

“A big deadline in the beauty and personal care regulatory landscape is fast approaching, with much more to come — although some experts believe this still isn’t enough.

Under the Modernization of Cosmetics Regulation Act, or MoCRA, passed by Congress at the end of 2022, cosmetics companies across the U.S. are required to register their facilities to the Food and Drug Administration by Monday, pushed back from the original deadline of December. They must also list each marketed cosmetic product, including product ingredients, and provide any updates annually. […]

As for what else is still to come, the industry is awaiting the FDA to issue guidance on good manufacturing practices, set to be published in 2025.

On this, Kelly A. Bonner, an associate at law firm Duane Morris, said: “They’re not reinventing the wheel. There are standards out there. It’s just going to be what the FDA say is the standard in the United States.” […]

Bonner, for one, believes the industry has been taking the changes seriously and that the goal for the FDA is to get through the first few years of MoCRA and then take stock.

“Ultimately FDA is going to take a hard look at it and think, ‘OK, what are our enforcement priorities now that we have the data, now that we’ve got everything in place? How do we tweak this? How do we refine this to better assist the industry, to better aid consumers?’”

To read the full text of this article, please visit the WWD website

 

 

FDA’s New Rule Regulates Lab-Developed Tests Under FD&C Act

On April 29, 2024, the U.S. Food and Drug Administration (FDA) announced a final rule that amends existing regulations to make explicit that in vitro diagnostic products and tests (IVDs), including laboratory developed tests (LDTs), are devices regulated under the Federal Food, Drug and Cosmetic Act (FD&C Act).

LDTs have increased in volume, complexity and importance in critical healthcare decision-making since 1976 when the Medical Device Amendments (MDA) were passed and FDA began exercising enforcement discretion. Accordingly, FDA has advised that increased oversight is needed for LDTs. However, some specific categories of LDTs will be covered under new targeted enforcement discretion policies.

Read the full Alert on the Duane Morris LLP website.

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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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