RA/QA News Roll: Mid July 2024
Here's what's happening at FDA and across the broader life science RA/QA space.
This is our biweekly recap of news and industry happenings curated for our paid subscribers. Our goal is to bring you the headline news and the stories, research, and insights that might be harder to find.
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Here are some key items from the past couple of weeks.
💊 = Pharma, biologic, and biotech.
💉 = Medical device, medtech, diagnostics, and digital health.
FDA Guidances, Regulations, and Related Documents
The FDA has released a pair of draft guidance documents concerning dental composite resin devices and dental curing lights. These guidance documents outline the process for companies to submit 510(k) applications for these devices. 💉
FDA General
CBER's Office of Therapeutic Products (OTP), responsible for regulating cell and gene therapy products, has announced the launch of a new initiative called the "Cellular and Gene Therapies Interactive Site Tours Program." This program is part of the FDA's efforts to enhance staff knowledge by offering tours of manufacturing facilities within the industry. These tours are designed to provide FDA personnel with firsthand insights into the production processes of these therapies, aiming to increase regulatory familiarity and understanding. 💊
The FDA has updated its FDALabel Database to version 2.9, enhancing the functionality for researchers. The database now enables custom searches across nearly 150,000 drug labels and includes a feature to download full search results as an Excel file. This update aims to provide greater accessibility and utility for researchers seeking comprehensive information on drug labels. 💊
The FDA has announced two upcoming meetings focusing on gene therapy treatments for rare diseases. One meeting will explore “Patient and Care Partner Perspectives on Safety Considerations for Approved Gene Therapy Treatments for Rare Diseases,” while the other will discuss “Patient and Care Partner Perspectives on Early Enrollment into Gene Therapy Clinical Trials for Rare Diseases.” Further details about these meetings are forthcoming, so stakeholders are encouraged to save the dates. 💊
The latest CDRH "town hall" meeting focused on medical device sterilization policy issues, particularly in response to new EPA regulations on ethylene oxide (EtO) emissions limits. (The slides are available here.) These regulations significantly impact the medical device industry, which largely relies on EtO for sterilization. The meeting featured a unique approach, with CDRH staff conducting a "role-playing" skit. The scenario simulated a pre-submission meeting where a device firm discussed proposed changes in sterilization methods and device modifications with the agency. Despite being scheduled for 90 minutes, the town hall concluded after approximately 45 minutes. The CDRH plans to address questions regarding the skit at the next town hall, scheduled for August 7th. 💉
The FDA has announced a new webinar focused on IVDs, specifically addressing Medical Device Reporting (MDR) requirements, correction and removal requirements, and quality system complaint requirements. This webinar is tailored to educate laboratories whose Laboratory-Developed Tests will be classified as IVDs under recently finalized regulations. Key topics include how these regulations impact reporting obligations and quality system compliance. Notably, certain requirements will begin taking effect as early as May 2025. 💉
The FDA is hosting a public workshop titled ADEPT-9 on September 6, aimed at enhancing diversity in therapeutics development for pediatric patients. This workshop is being cohosted by the University of Maryland. 💊
The FDA has decided to terminate its Allergenic Products Advisory Committee, citing infrequent meetings and a lack of ongoing necessity. The agency stated that integrating the committee's functions into the Vaccines and Related Biological Products Advisory Committee (VRBPAC) charter would be a more efficient use of resources, eliminating the expense of maintaining a separate advisory group. 💊
The FDA and Clinical Trials Transformation Initiative (CTTI) have announced a workshop focused on artificial intelligence in drug and biological product development. The workshop aims to discuss guiding principles employed by innovators and regulators to promote responsible AI usage in the development of safe and effective drugs.
The FDA has updated its webpage to include the latest adverse event safety signals identified by the FDA's Adverse Event Reporting System (FAERS). One of the signals currently under evaluation is the association between GLP-1 drugs and dysesthesia, a condition that affects the sensory perceptions one experiences from touching objects. 💊
The FDA's Office of Pharmaceutical Quality has issued an interesting contract notice indicating its intention to enhance its internal Quality Management Information System. The goal is to ensure compliance with the FDA Standard Manual Guide (SMG) 2020, specifically the FDA Quality System Framework for Internal Activities. 💊
The FDA is seeking applications from patient advocates interested in joining the Patient Engagement Collaborative (PEC), a program conducted in partnership with the CTTI. According to the FDA, the PEC facilitates discussions between the patient community and FDA staff on various topics aimed at enhancing meaningful patient engagement in medical product development and regulatory discussions. 💊
Governing
The Senate unanimously passed a bill restricting biologics manufacturers from challenging more than 10-20 patents in patent infringement cases related to pending biosimilar product approvals. The exact limit depends on the patents' issuance date. Courts have the discretion to increase this limit if the manufacturer demonstrates "good cause" or if it serves "the interest of justice." The legislation's purpose is to curb the practice of using extensive patent portfolios, known as "patent thickets," to engage competitors in prolonged litigation. 💊
The Senate approved the total budget allocation for the FDA in its recent appropriations report, paralleling the House version. This report is significant as it outlines legislative priorities, providing insight into what areas lawmakers wish the FDA to focus on. Read it here. 💊 💉
According to a report in MedTechDive, the FDA's Laboratory Developed Test rule is seen as a potential indicator of how federal agency authority may be tested in a post-Chevron regulatory landscape. The rule's implementation and any legal challenges it faces could provide insights into the scope and limits of agency authority under evolving regulatory interpretations. 💉
Rep. Josh Gottheimer (D-NJ) has announced a new sunscreen "safety plan" urging the FDA to streamline the review process for OTC sunscreen ingredients. The plan also calls for establishing a process for non-animal testing in drug development, specifically for sunscreens. Gottheimer's initiative highlights provisions of the 2020 CARES Act, which encouraged the FDA to take action on 16 specific sunscreen ingredients. 💊
Senator Bill Cassidy (R-La.) has sent a letter to the FDA, urging compliance with the Supreme Court's recent decision in Loper Bright v. Raimondo, which overturned the Chevron deference doctrine. In his letter, Cassidy emphasizes that the Supreme Court's decision presents an opportunity for executive agencies to reassess their roles relative to Congress and to prioritize legislative decisions made by elected representatives. Cassidy's letter specifically criticizes the FDA's regulatory approach to Laboratory Developed Tests, arguing that the agency lacks clear statutory authority for its actions in this area. He also raises concerns about the FDA's decisions regarding matters related to the Orphan Drug Act. 💊 💉
The recent Supreme Court decision in Ohio v. EPA may increase the burden on regulatory agencies like the FDA to provide substantive responses to all public comments received during rulemaking processes. This analysis suggests that the ruling could potentially slow down the rulemaking process, particularly in cases where there is a significant volume of comments submitted on a rule.
The decision in Ohio v. EPA appears to underscore the importance of agencies' responsibilities to engage meaningfully with public comments and to provide reasoned justifications for their regulatory actions. This requirement could lead to more thorough and time-intensive review processes as agencies strive to address and incorporate public feedback into their regulatory decisions. 💊 💉
Compliance and Enforcement
The FDA issued a warning letter to Sun Pharmaceutical, an Indian drug manufacturer, citing alleged violations of the agency's CGMP regulations. The letter highlights concerns regarding potential contamination and impurities found during inspections. 💊