On September 6, 2023, the FDA released three draft guidance documents that seek to “modernize” the 510(k) premarket notification process. Ever since the FDA first proposed “transformative new steps” to the program in 2018, the agency has promised to further update the 510(k) clearance pathway in an effort to better balance technological innovation and patient safety. In issuing these draft guidance documents, the FDA has followed through on that promise.
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.
Duane Morris Takeaways: On Thursday September 14, 2023, the FTC issued a policy statement warning brand drug companies that improper listing of patents in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the “Orange Book” could violate Section 5 of the FTC Act. The Hatch-Waxman Act and FDA regulations outline the criteria that brand drug companies must follow for listing patents in the Orange Book. Brand drug manufacturers that list patents in the Orange Book may obtain a 30-month stay of generic competition. According to the FTC, certain brand drug manufacturers have failed to follow that criteria, in some cases by submitting patents for listing in the Orange Book that claim neither the reference listed drug nor a method of using it. Under the new policy statement, FTC will scrutinize improper listings as a potential method of unfair competition under Section 5 of the FTC Act.
The policy statement is required reading for any corporate counsel involved in the submission of patent information in the Orange Book.
Implications for Brand Drug Manufacturers: Under the regulatory processes set up by Congress, the person who submits the patent information in the Orange Book listing must attest under penalty of perjury that the submission complies with the regulations. Drug manufacturers and individuals responsible for submitting such information are now on notice that the FTC intends to scrutinize improper Orange Book listings to determine whether they constitute an unfair methods of competition under Section 5 of the FTC Act or illegal monopolization. The policy statement also warns that individuals who submit or cause the submission of improper Orange Book patent listings may be held individually liable, including potentially having such cases referred to the U.S. Department of Justice for further investigation.
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.
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.
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.
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.
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.
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.
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.