FDA Regulatory News and Trends - May 12, 2023

Welcome to FDA Regulatory News and Trends, designed to help you identify significant legal developments and navigate the evolving business, legal and regulatory world.

 

FDA finalizes guidance on transitioning from temporary public health emergency policy on farm qualified exemption policy.

• The Final Guidance communicates FDA’s current thinking on how qualified exempt farms may transition away from the temporary flexibilities allowed during the COVID-19 public health emergency (PHE) and back to the qualified exemption eligibility criteria as established in the Produce Safety Rule.
  
  
• The ability of farms to shift food sales to available buyers had the potential to help reduce food shortages and waste, while also helping farms and the US economy. To support this shift, FDA issued its COVID Qualified Exemption guidance in May 2020, stating that FDA, for the duration of the PHE, did not intend to enforce certain criteria for determining qualified exemption eligibility under the Produce Safety Rule related to COVID-19.
  
  
• The prior guidance is intended to remain in effect until November 7, 2023, 180 days after the PHE expiration on May 11, 2023, to allow time for farms to adjust their activities and recordkeeping. Upon the expiration of the COVID Qualified Exemption guidance, qualified exempt farms will be expected to satisfy both prongs of the qualified exemption as described in the Produce Safety Rule. Farms that shifted sales away from qualified end-users during years affected by the PHE may not meet the qualified end-users-to-all-buyers proportion criterion; however, once the prior guidance expires, such farms must nevertheless have documentation that the average annual monetary value of all food sold during the relevant three-year periods was less than $500,000, adjusted for inflation.

FDA publishes notices regarding two upcoming studies on prescription drug promotion.

• The first study will seek to examine the impact of both HCP and non-HCP endorsement of prescription drugs in Direct-to-Consumer Television Advertisements.
  
  
• The second study will analyze how physicians and patients weigh prescription drug risk-benefit tradeoffs.
  
  
• The Office of Prescription Drug Promotion says the results of both studies will be considered in future policy determinations.

FDA conditionally approves first drug for anemia in cats with chronic kidney disease.

• Elanco Animal Health's Varenzin-CA1, conditional approved on May 1, 2023, is the first drug for the control of nonregenerative anemia associated with chronic kidney disease (CKD) in cats.
  
  
• Varenzin-CA1 increases the production of erythropoietin in the kidney, which in turn stimulates the bone marrow to produce more red blood cells.
  
  
• The conditional approval will be valid for one year and the drug company can renew the approval annually for a total of five years of conditional approval. During the five-year period, the drug company is expected to collect substantial evidence of effectiveness for full approval.

FDA public meeting on patient-focused drug development for Long COVID.

• The April 25, 2023 meeting was intended to “provide FDA with the opportunity to obtain initial patient and patient representative input on the aspects of Long COVID, including how Long COVID affects their daily life, symptoms that matter most to patients, their current approaches to treating Long COVID, and what they consider when determining whether or not to participate in a clinical trial.”
  
  
• At the meeting, patients and representatives reported on a varying range of symptoms affecting nearly all organ systems in the body, and described challenges associated with obtaining treatment for long COVID, including that most options focus on treating symptoms as opposed to the pathology of long COVID.
  
  
• Patients also encouraged an increase in clinical trials for diagnostics and treatments for long COVID, and it was noted that decentralized trials would be most practical.
  
  
• FDA likely will take the learnings from this meeting to inform regulatory and research priorities.  The docket for the meeting remains open for additional comments until June 26, 2023.

FDA publishes new draft guidance on the conduct of decentralized clinical trials (DCTs).

• The draft guidance, issued May 2, 2023, provides recommendations for sponsors, investigators, and other stakeholders regarding the implementation of DCTs for drugs, biological products, and devices.
  
  
• DCTs are clinical trials which employ technologies that allow investigators to remotely communicate with, and collect clinical data from, study participants.
  
  
• Use of DCTs increased quickly as a result of the COVID-19 pandemic, and up to now there have been some complaints of patchy regulatory governance and a lack of general definitions and expectations for DCT. The new draft guidance addresses some of these issues, including setting out a glossary of key terms related to DCTs.
  
  
• Through the guidance, FDA makes clear that regulatory requirements are the same for DCTs and traditional site-based clinical trials. The guidance discusses DCT design and communicates the importance of clearly defining roles and responsibilities between the various parties that may be involved in a DCT, as well as implementing a safety monitoring plan.
  
  
• The draft guidance is intended to work alongside other recently published draft guidance on digital health technologies (DHTs) and electronic systems in clinical research, creating a regulatory platform for research using digital tools.
  
  
• This is and will likely continue to be an active policy area for FDA, due to the rapid pace of digital technological advancements and FDA’s recognition that DCTs have the potential to expand access to more diverse patient populations and improve trial efficiencies.
  
  
• Comments on the draft guidance can be submitted to FDA’s docket until August 1, 2023.

Public meeting on developing good manufacturing practices for cosmetic products.

• FDA will hold a virtual public meeting on June 1, 2023 to solicit stakeholder input on developing GMP for cosmetic products in response to the passage of the Modernization of Cosmetics Regulation Act (MoCRA) on December 29, 2022.
  
  
• Topics that will be discussed at the June 1, 2023 meeting include:
  
  
  • Recognized national and international GMP standards and whether adoption of those standards would be burdensome for industry members
    
    
  • The extent to which cosmetics manufacturers already follow recognized GMP standards and the associated cost of implementing those standards
    
    
  • Flexibility within GMP’s to account for variation among industry members in terms of size and scope of businesses engaged in manufacturing of cosmetics
    
    
  • Simplified GMP’s for smaller businesses which do not impose a financial burden
    
    
  • Acceptable compliance times for GMP regulations and
    
    
  • Adverse events or recalls associated with a cosmetic product’s GMP’s including the impact GMP’s would have on the likelihood of a recall and adverse events
    
    
• Participants who wish to attend and/or present a public comment can register with FDA at this link.