FDA Roundup: August 1, 2023

FDA News Release

• For Immediate Release: August 01, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today, the FDA and the Drug Enforcement Administration provided an update on the ongoing actions being taken to resolve the shortages of prescription stimulant medications.
• On Monday, the FDA’s Center for Devices and Radiological Health (CDRH) announced that, beginning October 1, 2023, the Total Product Life Cycle Advisory Program (TAP) Pilot will expand to include the Office of Neurological and Physical Medicine Devices (OHT5). The TAP Pilot, launched in January 2023, is intended to help ensure that U.S. patients have access to high-quality, safe, effective, and innovative medical devices first in the world for years to come by promoting early, frequent, and strategic communications between the FDA and medical device sponsors. The TAP Pilot is one of the commitments agreed to between the FDA and industry as part of the MDUFA reauthorization.
• On Monday, the FDA approved dostarlimab-gxly (Jemperli, GlaxoSmithKline) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for primary advanced or recurrent endometrial cancer that is mismatch repair deficient, as determined by an FDA-approved test, or microsatellite instability-high. Immune-mediated adverse reactions occurred with dostarlimab-gxly, including pneumonitis, colitis, hepatitis, endocrinopathies such as hypothyroidism, nephritis with renal dysfunction and skin adverse reactions. The most common adverse reactions (greater than or equal to 20%) with dostarlimab-gxly in combination with carboplatin and paclitaxel were rash, diarrhea, hypothyroidism, and hypertension. View the full prescribing information for Jemperli.
• On Thursday, July 27, the U.S. District Court for the Eastern District of California entered a consent decree in United States v. Organic Pastures Dairy Co., LLC, et al., Case No. 08-cv-1786 (E.D. Cal.). RAW FARM, LLC f/k/a Organic Pastures Dairy Co., LLC (“Organic Pastures”) is a California-based company that manufactures and sells raw milk, raw cheese, and raw milk products and that is subject to a 2010 injunction. The FDA moved for contempt in March 2023, alleging that the company: (1) distributed an unapproved new drug in interstate commerce – namely, its raw cheddar cheese for the prevention of diseases such as heart disease, osteoporosis, and viral infections and (2) failed to affix required statements on its invoices, packaging slips and websites. In May 2023, the Court issued an order finding that Organic Pastures, its founder, and its president had violated the 2010 injunction and scheduled an evidentiary hearing regarding whether their noncompliance was justified. Prior to the hearing, the parties negotiated the consent decree, which, among other things, provides the FDA with additional oversight, enforcement, and inspection authority and imposes regular auditing requirements on the company.
• On Tuesday, July 25, the FDA cleared for marketing the DEKA ACE Pump System, an Alternate Controller Enabled (ACE) insulin pump that delivers insulin under the skin for people 13 years of age and older with diabetes mellitus. The DEKA ACE Pump System is a prescription-only device for single patient use. It can be used as a stand-alone insulin pump, or along with other diabetes devices that are also designed to be integrated into a customizable diabetes management system for automated insulin delivery. This FDA authorization paves the way for greater flexibility and patient choice for ACE pumps that can be used with an interoperable Automated Glycemic Controller (iAGC) to form an automated insulin dosing (AID) system. AID systems typically consist of a pump, CGM and software to control the system of compatible devices. This is the latest example of the FDA’s ongoing commitment to ensure the development and expansion of products that can improve advanced treatment and successful management of type 1 diabetes.