FDA Roundup: June 2, 2023

SILVER SPRING, Md., June 2, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today, the FDA provided an update on medical device reports it received that are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021. Since April 2021, the FDA has received more than 105,000 medical device reports, including 385 reports of death.
  
  
• Today, the FDA is making minor updates to the Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program final guidance. The Medical Device User Fee Amendments of 2022 (MDUFA V) includes refined performance goals related to FDA feedback for Pre-Submissions or "Pre-Subs," which are part of the Q-Submission Program. To address a MDUFA V commitment, the FDA intends to issue a revised draft guidance including information on when informal communication is appropriate instead of a Pre-Sub, among other updates. While this new draft guidance is being developed, the FDA is making minor procedural updates and clarifications on the mechanisms that stakeholders can use to request feedback. This final guidance provides minor clarifications on:
  
  
• Examples of common review topics and questions for a Pre-Sub
• Timing considerations for multiple submissions
• Administrative content to include in Q-Subs to facilitate FDA review
• Q-Sub meeting minutes format and submission process
• Existing mechanisms to obtain FDA feedback outside of the Q-Sub Program.
  
  
• On Thursday, the FDA revoked the emergency use authorization (EUA) of the Janssen COVID-19 Vaccine. On May 22, Janssen Biotech Inc. requested the voluntary withdrawal of the EUA for this vaccine. Janssen Biotech, Inc. informed the FDA that the last lots of the vaccine purchased by the U.S. Government have expired, there is no demand for new lots of the vaccine in the U.S., and they do not intend to update the strain composition of this vaccine to address emerging variants.
  
  
• On Thursday, the FDA alerted consumers that there are no FDA-approved products to treat molluscum, a common skin infection that some people try to self-diagnose and treat. Molluscum, also called water warts, is a viral infection that can cause white, pink or flesh-colored bumps. Do not use products that claim to treat molluscum, even if they say they are "FDA-approved" or "made in an FDA facility."
  
  
• On Thursday, the FDA announced the availability of a final guidance for industry entitled "Action Level for Inorganic Arsenic in Apple Juice." The final guidance identifies for industry the action level of 10 parts per billion (ppb) for inorganic arsenic in apple juice, issued in draft by the agency in 2013. The guidance supports the FDA's goal to reduce exposure to environmental contaminants from foods commonly consumed by babies and young children. As lower arsenic levels are more protective of public health, we expect to revisit this action level as part of the FDA's "Closer to Zero" action plan.
  
  
• On Wednesday, the FDA shared updates on our activities to better understand PFAS in the general food supply. This included our most recent testing for certain PFAS in Total Diet Study (TDS) samples. The FDA has concluded that exposure to certain PFAS for which there are toxicological reference values, at the levels measured in seven samples, are not likely to be a health concern for young children or the general population. To date, FDA has not detected PFAS in over 97% (701 out of 718) of the fresh and processed foods tested from the TDS. The agency also provided more information related to PFAS in seafood and our plans for a second targeted sampling assignment, as well as recent advances in our testing methodology and approach, and other research activities.
  
  
• On Wednesday, the FDA approved Abrysvo, the second respiratory syncytial virus (RSV) vaccine approved for use in the United States. Abrysvo is approved for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older. In an ongoing clinical trial, approximately 17,000 individuals have received Abrysvo and approximately 17,000 individuals have received a placebo. Data from the first RSV season of the study were available for the FDA's analysis. Abrysvo reduced the risk of developing RSV-associated LRTD with two or more symptoms by 66.7% and with three or more symptoms by 85.7%. Among a subset of clinical trial participants, the most commonly reported side effects were fatigue, headache, pain at the injection site and muscle pain. Guillain-Barré syndrome was reported 7 days after receipt of Abrysvo in one participant and Miller Fisher syndrome (a variant form of Guillain-Barré syndrome), was reported 8 days after receipt of Abrysvo in one participant. Atrial fibrillation within 30 days after vaccination was reported in 10 participants who received Abrysvo and 4 participants who received placebo. The FDA is requiring the company, Pfizer Inc., to conduct a postmarketing study to assess the signal of serious risk for Guillain-Barré syndrome. In addition, although not an FDA requirement, the company has committed to assess atrial fibrillation in a postmarketing study. Additional information is available on the FDA's website.
  
  
• On Wednesday, the FDA and the European Union (EU) announced their decision to expand the scope of the U.S.-EU Mutual Recognition Agreement (MRA) Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMP) to include inspections of veterinary pharmaceuticals (also called "animal drugs"). This MRA entered into force on November 1, 2017, but initially included only pharmaceuticals intended for human use. Wednesday's action to include animal drugs in the MRA is an important step in ensuring the safety and quality of animal drug products and will enhance efficiencies for the U.S. and EU regulatory systems.
  
  
• On Tuesday, the FDA posted information about medications containing semaglutide marketed for type 2 diabetes or weight loss. There are currently three FDA-approved semaglutide products which are only available with a prescription. Due to two of the drugs being in shortage, these two drugs are able to be compounded if they meet certain requirements in the Federal Food, Drug, and Cosmetic Act. The FDA has received adverse event reports after patients used compounded semaglutide. The FDA has also received reports that in some cases, compounders may be using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate, which have not been shown to be safe or effective. The salt forms are different active ingredients than is used the approved drugs, which contain the base form of semaglutide. Patients should be aware that some products sold as 'semaglutide' may not contain the same active ingredient as FDA-approved semaglutide products and may be the salt formulations. Patients should only obtain drugs containing semaglutide with a prescription from a licensed health care provider, and only obtain medicines from state-licensed pharmacies or outsourcing facilities registered with the FDA.

 Additional Resources: 

• FDA Newsroom 

Media Contact: FDA Office of Media Affairs, 301-796-4540  
Consumer Inquiries: 888-INFO-FDA 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. 

SOURCE U.S. Food and Drug Administration