Duane Morris attorneys Rick Ball and Coleen Hill will be speakers at MassMEDIC’s Regulatory Roundup, to be held on November 15, 2023 from 8:00 a.m. to 4:15 p.m. Rick and Coleen will present “When Things Go Wrong: Navigating Enforcement When the FDA, SEC, and DOJ Are All Involved.” For more information and to register for this hybrid event, please visit the MassMEDIC website.
Federal Regulatory Laws Due Overhaul after MoCRA
On December 23, 2022, Congress enacted the Modernization of Cosmetics Regulation Act (MoCRA)—the first major statutory change to the U.S. federal government’s ability to regulate cosmetics since 1938. Passed with bipartisan
and industry support, MoCRA expands the Food and Drug Administration’s authority over cosmetics, and creates substantial new obligations for manufacturers, packers and distributors of cosmetics intended for sale in
the United States. Here’s what beauty companies need to know.
To read the full text of this article by Duane Morris attorney Kelly Bonner, please visit the firm website,
FTC Targets Private Equity in Challenge to Anesthesiology Roll-Ups
On September 21, 2023, the Federal Trade Commission sued U.S. Anesthesia Partners Inc. and Welsh, Carson, Anderson & Stowe XI L.P., among other private equity funds, in the United States District Court for the Southern District of Texas under the antitrust laws. Specifically, FTC alleges that the defendants engaged in an anti-competitive scheme to consolidate anesthesia practices in Texas and to force other independent anesthesia groups into price-setting arrangements that violated Section 2 of the Sherman Act, Section 7 of the Clayton Act and Section 5 of the FTC Act.
To read the full text of this Duane Morris Alert, please visit the firm website.
FDA’s New Electronic Portal for Facility Registration and Product Listing of Cosmetic Product Facilities and Products Under MoCRA
Continuing its implementation of the Modernization of Cosmetics Regulation Act’s (MoCRA), and following on the heels of FDA’s Draft Guidance on Facility Registration and Product Listing (previously discussed here), on September 15, 2023, FDA announced its newly developed draft electronic submission portal, Cosmetics Direct, to assist persons submitting cosmetic product facility registrations and product listings under newly added Section 607 of the federal Food, Drug and Cosmetic Act (FD&C Act).
Draft screenshots of the electronic system, including example submissions, are available for review and comments, along with an interim Federal Register Notice, announcing the new system.draft guidance,
To read the full post by Duane Morris attorney Kelly A, Bonner, please visit the Duane Morris Fashion, Retail and Consumer Branded Products Blog.
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.
Article in Business of Fashion Quotes Kelly Bonner
Duane Morris attorney Kelly A. Bonner was quoted in an article in The Business of Fashion titled “What Beauty Needs to Know About the Biggest New Regulations in 80 Years,” about the Modernization of Cosmetics Regulations Act (MoCRA) recently signed into law. To read the full text of this article, please visit the firm website.
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.