FDA Roundup: May 19, 2023

FDA News Release

• For Immediate Release: May 19, 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 announced that the National Academies of Sciences, Engineering, and Medicine (NASEM) will conduct an independent study on challenges in supply, market competition, and regulation of infant formula in the United States. Upon completion of the study, NASEM will submit a report to both Congress and the FDA. The FDA will use the information gained through the NASEM study to develop a long-term national strategy.
• On Thursday, the FDA approved Rinvoq (upadacitinib) for adults with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers. Rinvoq is the first approved oral product available to treat moderately to severely active Crohn’s disease. The most common side effects of Rinvoq as indicated for Crohn’s disease are upper respiratory tract infections, anemia, fever, acne, herpes zoster, and headache. See full prescribing information for additional information on risks associated with Rinvoq. additional information on risks associated with Rinvoq.
• On Thursday, the FDA issued marketing denial orders to the firm Mothers Milk WTA for more than 250 flavored and tobacco-flavored e-liquids. After completing initial acceptance review and subsequently proceeding to and completing a substantive scientific review of the company’s premarket tobacco product applications (PMTAs), the FDA determined that the applications lacked sufficient evidence to show the products are appropriate for the protection of public health. Following the FDA’s rigorous scientific review, tobacco products that receive a marketing denial order may not be offered for sale, distributed, or marketed in the U.S.
• On Thursday, the FDA published a Small Entity Compliance Guide for the Food Safety Modernization Act (FSMA) Food Traceability Rule. The compliance guide describes the requirements of the Food Traceability regulation to assist small entities, including farms and small businesses, in complying with the applicable recordkeeping requirements. 
• On Thursday, the FDA published a Spotlight on CDER Science focused on the role of disclosures in helping consumers understand oncology clinical trial endpoints in direct-to-consumer television advertisements for prescription drugs. In a recent study, the FDA researchers found people have some difficulty in differentiating progression-free survival and overall response rate from overall survival in drug advertisements without a disclosure saying the therapy has not yet been shown to extend life. These findings demonstrate that individuals may be overly optimistic when they see ads with claims about overall response rate and progression-free survival without a disclosure. 
• On Thursday, the FDA granted marketing authorization of the B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System (BRAHMS GmbH, Part of Thermo Fisher Scientific) to aid in the risk assessment of certain pregnant women hospitalized for hypertensive disorders (preeclampsia, chronic hypertension with or without superimposed preeclampsia, or gestational hypertension) for the progression to preeclampsia with severe features. The test system is an automated immunofluorescent assay that uses Time-Resolved Amplified Cryptate Emission (TRACE) technology for the quantitative detection of placental biomarkers, Placental Growth Factor (PlGF) and Soluble Fms-like tyrosine kinase-1 (sFlt-1) in human serum and plasma. 
• The B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System is to be used in conjunction with other laboratory tests and clinical assessments to aid in the risk assessment of pregnant women for progression to preeclampsia with severe features (as defined by the American College of Obstetricians and Gynecologists (ACOG) guidelines) within 2 weeks of presentation. According to the CDC, preeclampsia is one of the leading causes of maternal morbidity and is estimated to occur in 3% to 7% of all pregnancies. The hallmarks of preeclampsia are high blood pressure and signs of liver or kidney damage and usually develops after the 20th week of pregnancy. Annually, preeclampsia is responsible for over 70,000 maternal deaths and 500,000 fetal deaths worldwide.
• The B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System received FDA Breakthrough Device designation and is the first device to receive marketing authorization to aid in the prognosis of preeclampsia with severe features in pregnant women. The granting of this De Novo request for BRAHMS GmbH, is the latest example of the FDA’s ongoing commitment to advance access to diagnostic testing that has a reasonable assurance of safety and effectiveness and is intended to aid health care professionals in making more informed decisions for patients.
• On Wednesday, the FDA issued two draft guidances for industry entitled, Pediatric Drug Development: Regulatory Considerations – Complying with PREA and Qualifying for Pediatric Exclusivity Under the BPCA and Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations. Both guidances, once finalized, will provide recommendations to support the approval of pediatric drug products that are subject to the Pediatric Research Equity Act (PREA) and/or the Best Pharmaceuticals for Children Act (BPCA). The guidance documents revise and replace the draft guidance for industry How to Comply with the Pediatric Research Equity Act.  
• On Wednesday, the FDA issued an import alert for the disposable e-cigarette brand Elf Bar (EB Design) to prevent their illegal tobacco products from entering the U.S. marketplace. This action is part of the FDA’s commitment to protecting youth from illegal e-cigarette products, including flavored disposables that are popular among youth.
• An import alert places these tobacco products on the red list, which makes them subject to Detention Without Physical Examination (DWPE) and allows the FDA to detain a product without physically examining it at the time of entry. An import alert for Esco Bars e-cigarette products was issued on May 12, 2023, and an import alert for Eon Smoke has been in place since May 2020. Given that Elf Bar, Esco Bars and Eon Smoke tobacco products do not have the required authorization from the FDA to be marketed legally, the FDA has issued import alerts for all tobacco products under these brands to allow FDA to detain them without physical examination. 
• The import alerts help prevent violative products from being distributed in the United States.
• On Tuesday, the FDA announced the availability of a pre-recorded webinar for developers who are interested in learning more about the process of requesting an Investigational Food Use Authorization (IFUA) for animals with investigational intentional genomic alterations (IGAs). IGAs in animals are alterations to the animal’s genome that are made using genome editing or rDNA technologies.