FDA Roundup: January 31, 2023

FDA News Release

• For Immediate Release: January 31, 2023

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

• Today, Brian King, director of the Food and Drug Administration’s Center for Tobacco Products (CTP), published a perspective looking back on the Center’s progress on tobacco regulation in 2022, and a look ahead into 2023. The perspective shares information on key priority areas including non-tobacco nicotine, product standards, compliance and enforcement, product review and authorization, public health education, and health equity.
• Today, the FDA and the Reagan-Udall Foundation for the FDA announced a virtual public meeting on March 8-9 titled, Understanding Fatal Overdoses to Inform Product Development and Public Health Interventions to Manage Overdose. The meeting will include stakeholders—including people who use drugs, their families, harm reduction programs, clinicians, academic researchers, and federal partners, and will explore the evolving context surrounding fatal overdoses as participants will discuss epidemiological trends, drug supply changes, public health interventions to manage overdose, and drug development opportunities.
• Today, the FDA issued warning letters to five companies for illegally selling products for treating or preventing human monkey pox (mpox). There are no FDA-approved treatments for mpox. The FDA approved the Jynneos vaccine for the prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox or mpox infection. At this time, public health authorities have not recommended the general public needs to be vaccinated against mpox. Consumers concerned about mpox should consult their health care provider. 
• On Thursday, the FDA’s Center for Devices and Radiological Health released its 2022 Annual Report highlighting the Center’s programmatic accomplishments through December 31, 2022, including the Pandemic Response, the Medical Device User Fee Amendment (MDUFA) V, Device Innovation, Over-the-Counter (OTC) Hearing Aid Final Rule, and Device Safety.
• On Thursday, the FDA authorized the marketing of three new tobacco-flavored heated tobacco products included in Philip Morris Products S.A.’s supplemental premarket tobacco product applications (PMTAs). The products receiving marketing granted orders are Marlboro Sienna HeatSticks, Marlboro Bronze HeatSticks, and Marlboro Amber HeatSticks. These products are modified versions and line extensions of a previously authorized tobacco-flavored product. 
  • The three HeatSticks products are “heated tobacco products” (HTPs) used with the IQOS device, an electronic device that heats tobacco-filled sticks wrapped in paper to generate a nicotine-containing aerosol. 
  • Based on the FDA’s review of the supplemental PMTAs, the agency determined that the marketing of these products should be authorized because, among other things, the net population-level benefits to adult smokers outweigh the risks to youth. 
  • While the FDA is authorizing the marketing of these products, it does not mean these products are safe nor “FDA approved.” All tobacco products are harmful; however, different tobacco products pose varying levels of health risk to users, with combustible tobacco products being the most harmful. There are no safe tobacco products, so those who do not currently use tobacco products, especially young people, should not start.
  • Note: FDA may withdraw the marketing orders if the agency determines that, among other things, the benefits no longer outweigh the risks at the population level.
• Each month, the FDA Grand Rounds lecture series highlights a key public health challenge, and how the FDA is applying science and innovation to its regulatory activities. The agency invites you to attend the next presentation on Feb. 9, 2023, from 12 to 1 p.m. ET, on the topic, “A Modular Approach for Enhanced Plasmid Subtyping and AMR Gene Profiling of Plasmids.” Antimicrobial resistance, or AMR, refers to the ability of a microorganism to resist the effects of a drug; it is a serious, complex and costly public health problem. Plasmids are a major factor in the spread of antimicrobial resistance genes. Current plasmid typing methods do not account for the great degree of genetic diversity associated with the recombination mechanisms that allow plasmids to acquire these resistant genes. In this presentation, the FDA Center for Veterinary Medicine will demonstrate a new plasmid classification method that identifies the genetic elements exclusive to and indicative of a plasmid type, and characterizes plasmids based on the DNA sequence and relative position of these genetic elements as they are rearranged through plasmid recombination mechanisms. This approach offers an important tool to help enhance efforts to combat antimicrobial resistance.
• FDA’s Center for Devices and Radiological Health (CDRH) is pleased to announce that EXCITE International and Highmark have joined the FDA’s Early Payor Feedback Program (EPFP), bringing the total to 15 payor organizations available to provide feedback to medical device innovators. CDRH established the Early Payor Feedback Program to facilitate communication between device manufacturers and payors to potentially shorten the time between FDA approval or clearance and coverage decisions. By communicating earlier, manufacturers may design their clinical trials to produce the data required for regulatory approval or clearance and for positive coverage determinations, which may expedite patient access. The Early Payor Feedback Program is a voluntary opportunity for medical device sponsors to obtain payor input on clinical trial design or other plans for gathering clinical evidence needed to support positive coverage decisions. Since the program’s inception in 2016, the Early Payor Feedback Program has connected more than 80 medical device companies with payors.
• COVID-19 testing updates: 
  • As of today, 443 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 298 molecular tests and sample collection devices, 85 antibody and other immune response tests, 59 antigen tests, and one diagnostic breath test. There are 79 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, two EUAs for antigen prescription at-home tests, 26 EUAs for antigen over-the-counter (OTC) at-home tests, and four for molecular OTC at-home tests.
  • The FDA has authorized 44 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 1217 revisions to EUA authorizations.