Intergovernmental Affairs

Weekly Digest for the Week of Jan. 24, 2022

Good afternoon. The FDA Intergovernmental Affairs (IGA) team would like to bring to your attention the following announcements the Agency made during the week of January 24, 2022. If you have any questions on the below announcements, please reach out to us at IGA@fda.hhs.gov. 

FDA Warnings and Recalls

• On January 6, 2022, FDA announced that the Agency and CDC, in collaboration with state and local partners, are investigating illnesses in a multistate outbreak of E. coli O157:H7. As of January 6, 2022, 10 people infected with the outbreak strain of E. coli O157:H7 have been reported from four states. States with cases include: AK (2), OH (1), OR (1), and WA (6). Consumer purchase data indicate that seven people purchased Nature's Basket Power Greens or Simple Truth Organic Power Greens at grocery stores before becoming sick. Based on those purchase dates, the latest “best if used by” date is estimated to be December 20, 2021. These two salad blends consist of organic spinach, mizuna, kale, and chard; both brands were manufactured by the same processor. To date, no single production code has been identified by the traceback. For the estimated production code range that may have been available for purchase to ill consumers, records collected indicate that leafy greens used in these products were sourced from Salinas and Imperial Valley, CA, and Yuma, AZ. FDA continues to evaluate the available information to determine if a single source, such as a farm or ranch, can be identified. Although this product is past expiration and should no longer be available for purchase, if consumers froze Nature’s Basket or Simple Truth Power Greens salad blend with a “Best if Used By” date through December 20, 2021, they should discard it. FDA and state partners are continuing to work with firms of interest to determine if there are additional or unexpired products that could potentially be affected. This is an ongoing investigation and additional information will be provided as it becomes available.

COVID-19 Updates

• On January 24, 2022, FDA revised the authorizations for two monoclonal antibody treatments – bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) – to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments. Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time. In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions. For more information, click here.

• Testing updates:
  • As of today, 422 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 290 molecular tests and sample collection devices, 87 antibody and other immune response tests and 45 antigen tests. There are 69 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, three EUAs for antigen prescription at-home tests, 14 EUAs for antigen over-the-counter (OTC) at-home tests and three EUAs for molecular OTC at-home tests.
  • The FDA has authorized 25 antigen tests and nine molecular tests for serial screening programs. The FDA has also authorized 774 revisions to EUA authorizations.

Devices

• On January 26, 2022, FDA issued final guidance encouraging voluntary patient engagement in clinical studies. FDA believes medical device clinical studies designed with patient input may help to address common challenges faced in medical device clinical studies. While FDA acknowledges that patient engagement may be beneficial across the total product lifecycle, this guidance focuses on the applications of patient engagement in the design and conduct of medical device clinical studies. You can find more information in here.
• FDA issued a final guidance to describe principles that should be considered when using Patient-Reported Outcome (PRO) instruments in the evaluation of medical devices and provide recommendations about the importance of ensuring the measures are fit-for-purpose, on January 26, 2022. This guidance is not meant to replace the Patient-Focused Drug Development (PFDD) guidance series. Click here to read more.
• On January 26, 2022, FDA provided an update related to the recall of certain Philips Respironics ventilators. In December 2021, Philips Respironics initiated a recall of certain Trilogy Evo ventilators distributed between April 15, 2021 and May 24, 2021 with specific serial numbers. FDA classified this recall as a Class I recall in January 2022. These devices were not included in the June 2021 recall of Philips Respironics ventilators, continuous positive airway pressure (CPAP), and bilevel positive airway pressure (BiPAP) machines. As noted during a recent FDA inspection, an incorrect and non-specified polyester polyurethane, raw foam product, not intended for use in Trilogy Evo ventilators, was used to manufacture certain Trilogy Evo ventilators with specific serial numbers. The foam was determined to be PE-PUR foam, the same foam used in Philips Respironics devices previously recalled in June 2021. You can read more here.

• On January 26, 2022, FDA provided an update related to the recall of certain Philips Respironics ventilators. In December 2021, Philips Respironics initiated a recall of certain Trilogy Evo ventilators distributed between April 15, 2021 and May 24, 2021 with specific serial numbers. FDA classified this recall as a Class I recall in January 2022. These devices were not included in the June 2021 recall of Philips Respironics ventilators, continuous positive airway pressure (CPAP), and bilevel positive airway pressure (BiPAP) machines. As noted during a recent FDA inspection, an incorrect and non-specified polyester polyurethane, raw foam product, not intended for use in Trilogy Evo ventilators, was used to manufacture certain Trilogy Evo ventilators with specific serial numbers. The foam was determined to be PE-PUR foam, the same foam used in Philips Respironics devices previously recalled in June 2021. FDA also developed a FAQ page on Philips Respironics CPAP, BiPAP, and Ventilator Recalls, which it updates frequently. For more information, click here.  

Drugs and Biologics

• On January 26, 2022, FDA published a series of guidances focused on generic drug application submissions, labeling, and review.  These guidances support FDA’s Drug Competition Action Plan (DCAP), which encourages robust and timely market competition for generic drugs. The guidances are part of our continued efforts to bring greater efficiency and transparency to the generic drug review process, which helps spur competition and improves consumer access to the medicines they need at affordable prices. Bringing more competition to the market and addressing the high costs of medicines are top agency priorities.

Food and Food Safety

• FDA is initiating tribal consultation on the recently published proposed rule “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water.” The proposed rule published in the Federal Register on December 6, 2021. FDA Deputy Commissioner for Food Policy and Response Frank Yiannas invites you or your designated consultation official to a consultation conference call on February 4, 2022 at 1:00 p.m. EST. PLEASE NOTE THE CONFERENCE CALL INFORMATION HAS CHANGED. The call will now take place via Zoom.gov. To participate in the call, you must register HERE. FDA sincerely apologizes for the inconvenience. For additional information, including FDA’s Dear Tribal Leader Letter Invitation to Consultation, please visit FDA’s website here. 
• On January 25, 2022, FDA proposed a new rule to amend our regulation (21 CFR 170.105) on how and when the FDA may determine that a pre-market notification for a food contact substance is no longer effective. A list of effective food contact notifications (FCNs) can be found on FDA’s website. If finalized, the proposed rule would, among other things, allow the FDA additional flexibility in how it determines that an FCN is no longer effective and help ensure that FDA’s inventory of effective FCNs is current based on use and safety.  Primarily, this rule would enable the FDA to determine that an FCN is no longer effective when the manufacturer discontinues its use based on reasons other than safety, for example, they no longer produce, supply, or use the food contact substance. In addition, the rule would give manufacturers or suppliers an opportunity to provide input before the FDA determines that an FCN is no longer effective.  The proposed rule would also increase the FDA’s ability to reduce redundancy across FCNs, food additive regulations, and threshold of regulation exemptions. You can read more here.
• FDA posted an at-a-glance fact sheet for the FDA Food Safety Modernization Act (FSMA) final rule on Laboratory Accreditation for Analyses of Foods (LAAF), on January 25, 2022. The final rule establishes a laboratory accreditation program for the testing of food in certain circumstances. Under the LAAF program, FDA will recognize accreditation bodies (ABs) that will accredit laboratories to the standards established in the final rule (referred to as LAAF-accredited laboratories). Find more information by clicking here.
• FDA announced it will be holding two virtual public meetings on the recently released proposed rule “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water.”  The purpose of the public meetings is to discuss the proposed rule, which was issued under the FDA Food Safety Modernization Act. These public meetings are intended to facilitate and support the public's evaluation and commenting process on the proposed rule. The meetings are as follows: February 14, 2022, 11:45 am - 7:45 pm EST; and February 25, 2022, 8:45 am - 4:45 pm EST. Registration is required to attend the virtual meetings. Please click here for registration details.

Tobacco

• On Jan. 27, the FDA published an FDA Voices article by Center for Tobacco Products Director Mitch Zeller discussing the agency’s commitment toward advancing two proposed tobacco product standards—one prohibiting menthol as a characterizing flavor in cigarettes and another prohibiting all characterizing flavors (including menthol) in cigars. The FDA Voices highlights how these product standards would be a significant step in addressing tobacco-related health disparities and reducing tobacco-related disease and death. The FDA remains on track to advance the proposed product standards in the spring.  Read full blog post here.

Veterinary Food and Medicine

• FDA announced on January 12, 2022, that the agency will hold a public hearing on Scientific Data and Information Related to the Residue of Carcinogenic Concern for the New Animal Drug Carbadox, a carcinogenic new animal drug used in swine feed. The public hearing will be held virtually on March 10, 2022, via Zoom from 1:00 to 5:00 p.m. ET. Under the Delaney Clause (section 512(d)(1)(I)) of the Food, Drug, and Cosmetic Act (FD&C Act), FDA generally cannot approve an application for a carcinogenic new animal drug.  An exception to this general rule is commonly known as the Diethylstilbestrol “DES” Proviso, which allows for the approval of a carcinogenic new animal drug where the FDA finds that under the approved conditions of use: (1) The drug will not adversely affect the animals treated with the drug; and (2) no residues of the drug will be found by an approved regulatory method in any edible tissues of, or in any foods yielded by, the animal. On July 20, 2020, the Agency published a notice in the Federal Register proposing an order to revoke the approved method for detecting residues of carbadox. A presiding officer will conduct the hearing, accompanied by other employees of the United States government serving as a panel. You can read more here.