FDA’s Second Warning Letter of the Year Deals with Potentially Misleading Efficacy Claims About Inhaler

On August 15, 2023, the U.S. Food and Drug Administration (FDA) published a warning letter to AstraZeneca Pharmaceuticals LP, alleging that a professional sales brochure for its Breztri Aerosphere (budesonide, glycopyrrolate and formoterol fumarate) inhalation aerosol contained false or misleading claims regarding the drug’s efficacy.

In view of the warning letter—only the second of the year issued by the Office of Prescription Drug Promotion (OPDP)—companies should review their promotional materials to confirm that any efficacy claims are clearly supported by cited data and do not give rise to misleading impressions and regulatory scrutiny—even where such materials are intended for patients.

Read the full Alert on the Duane Morris LLP website.

FDA Drafts Guidance on Pre-market Submissions for Patient-Matched Guides to Orthopedic Implants

This summer, the U.S. Food and Drug Administration (FDA) issued draft guidance regarding patient-matched guides to orthopedic implants, which are intended to assist in the execution of a pre-surgical plan concurred upon by the patient’s healthcare professional to position an orthopedic implant in a way consistent with the implant’s indicated use. In the draft guidance, FDA recommends information to include in pre-market submissions for patient-matched guides to orthopedic implants. FDA also suggests information for manufacturers to consider when creating the design process for patient-matched guides.

To read the full alert, visit the Duane Morris website.

Nitrosamine Impurities FDA Guidance

By Alan Klein, Patrick Gallagher and Michael Fox

On August 4, 2023, the FDA issued a new Guidance to the pharmaceutical industry relating to large molecule drugs left unaddressed in its earlier nitrosamine Guidance publications. (Access the complete Guidance or the abbreviated version.)

Reacting to considerable input from the pharmaceutical industry, both brand and generic, following the agency’s Federal Register request for and receipt of extensive comments on these issues, including scientific data furnished to the agency by NDA and ANDA sponsors over the past year and a half, FDA has now provided drug manufacturers with critical guidelines for conforming their products to what the agency has determined to be safe nitrosamine exposure limits for patients. This comes on the heels of setting similar exposure limits for these products late last month by the European Union’s chief drug regulator, the European Medicines Agency. In its current Guideline, FDA has ranked impacted prescription drugs into 5 categories depending upon their carcinogenic potency, with “1” being the most potent, and “5” the least. Instructing the industry on their responsibility to minimize or eliminate nitrosamine impurities in their products to the extent feasible, the agency has extended the timeline for this task to August 2025, recognizing the complexity of this process and the need to avoid recalls and market disruptions of widely prescribed and important medications.

Minor Procedural Updates to FDA Guidance on Q-Submissions

On June 2, 2023, the FDA issued its most recent guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. The Q-Sub Program is used by the FDA to track the requests for feedback and interactions between the FDA and medical device companies prior to submitting for FDA approval. The 2023 guidance provides updated resources and tools for medical device companies, or submitters, looking to request feedback from the FDA during the development process of potential or planned medical devices.

Read the full Alert on the Duane Morris LLP website.

Beauty and Personal Care Products Post-MoCRA Regulatory Compliance Checklist

MoCRA, Pub. L. No. 117-328, represents the first major statutory change to the authority of the Food and Drug Administration (FDA) to regulate cosmetics since the Food, Drug, and Cosmetics Act (FDCA), 21 U.S.C. § 361 et seq.,
in 1938 and the Fair Packaging and Labeling Act (FPLA), 21 C.F.R. § 701.3, in 1966.

This checklist outlines key regulatory compliance considerations that are specific to personal care products marketed in the United States following the enactment of the federal Modernization of Cosmetics Regulation Act (MoCRA) on December 23, 2022.

To read the full text of this Lexis Nexis Practical Guidance Checklist by Duane Morris attorneys Driscoll Ugarte, Rick Ball, Alyson Lotman, Kelly Bonner and Coleen Hill, please visit the firm website.

What Sunscreen Regulation Means for the Spa Industry

Kelly Bonner’s article for Well Spa 360 discusses recent sunscreen recalls, regulation and its impact on spa businesses.

“It’s hard to underestimate the importance of regularly wearing sunscreen to protect the skin from harmful ultraviolet rays. But recent reports suggest traces of benzene in sunscreens and a link to human health ailments have led to several voluntary recalls and consumer class litigation involving well-known brands. Concerns about whether certain sunscreens are actually “green,” “sustainable” or “reef-friendly” have left consumers in the dark about what those terms mean, while leaving brands vulnerable to consumer class action litigation.

“Here’s what spas need to know about the most recent controversies surrounding sunscreen.”

Read the full article at WellSpa360.com.

Outlook for Life Sciences M&A: Industry Drivers Still Strong

In a recent GEN Edge article, Duane Morris partner Rebecca Guzman discussed the state of M&A activity in the life sciences.

“Following the most robust year for life sciences M&A on record, the sector saw a sharp decline in 2022 to levels below what we last experienced pre-pandemic. Many analysts pointed to supply chain issues, clinical development delays and other lingering effects of the COVID-19 pandemic as the cause. The 2021 catalysts of innovation following the pandemic breakout had finally worn off. On the surface, it appeared that key industry players had taken a step back, or even hit pause, but continued background activity tells a different story. While deal flow declined, the underlying drivers of M&A activity throughout 2022 (and continuing through today) remain strong.”

Read the full article at genengnews.com.

Silica Exposure-Related Lawsuits in California Exploding

Silica is an abundant mineral found in materials including sand, stone, and concrete. While serving as a principal component of glass, cement, and ceramics, silica also presents an increasingly pertinent issue for those with interests in toxic torts, as well as businesses involved in the manufacturing or distribution of silica products: occupational exposure to airborne silica, a leading cause of silicosis and lung cancer.

Silicosis is a severe, incurable lung disease that is often fatal. Upon inhalation of fine particles created through workers’ manipulation of the material, small amounts of silica become trapped in the lungs, causing the scarring of lung tissue. Resulting effects are severe, often requiring lifelong care and a possible lung transplant.

Cases commonly appear among those working in construction or mining, and symptoms can present after only a few years of occupational exposure. More often than not, workers use little to no protective equipment, leaving them vulnerable to inhalation of the harmful substance. With the number of silicosis cases on the rise, the issue has been denoted an “emerging epidemic” constituting a “public health problem of great urgency.”

To read the full text of this blog post by Duane Morris partner Robert Kum, please visit the Duane Morris Products Liability Blog.

Supreme Court Affirms Federal Circuit Ruling Regarding Satisfaction of Enablement Requirement

On May 18, 2023, the Supreme Court of the United States issued its opinion in Amgen, Inc. v. Sanofi, clarifying the standard of satisfying the enablement requirement, in particular, for broad functional genus claims. The Court, in a unanimous decision affirming the Federal Circuit’s holding, focused on whether the specification enabled the full scope of the invention to be practiced.

To read the full text of this Duane Morris Alert, please visit the firm 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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