RA/QA News Roll: Mid May 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.
If you haven’t upgraded to a paid subscription yet, you can do so here. Also, make sure to follow us on LinkedIn.
We’ve added emojis to our links to denote pharma/biologic items (💊) from device/diagnostic/digital health items (💉) when there’s a clear relevance to only one sector.
Also, be sure to catch the latest episodes of our podcast, The Life Science Rundown:
Crafting Quality Systems for Each Phase of Drug Development with Carlos Yuraszeck
Navigating FDA Regulations for SaMD AI and Machine Learning with Adam Foresman
Here are some key items from the past couple of weeks.
FDA Guidances, Regulations, and Related Documents
A new batch of updated documents from the International Medical Device Regulators Forum (IMDRF), a device harmonization group of which the FDA is a founding member, has been released. These updated editions cover various topics, including competence requirements for regulators, essential safety and performance principles, device labeling, recognition of conformity assessment bodies, and more. 💉
The Government Accountability Office (GAO) has released a new report urging the FDA to assist in addressing coordination challenges with the Strategic National Stockpile (SNS). The SNS serves as a repository of pre-staged emergency equipment to aid in responding to natural disasters and public health emergencies. The report specifically calls on the FDA to help develop guidance for managing expiring inventory, as medical countermeasures often need to be stored in the SNS for many years beyond their labeled expiration dates. The report emphasizes that such guidance would be beneficial to prevent the disposal of large quantities of medical countermeasures that could still be tested for usability and maintained for future emergencies. 💊
The FDA has released a new guidance document concerning Risk Evaluation and Mitigation Strategies (REMS), which are implemented to manage the risks associated with drugs that pose significant safety concerns. The guidance specifically emphasizes logic models designed to assist regulators and sponsors in assessing whether the REMS program is achieving its intended outcomes. 💊Read our breakdown:
The FDA has released a highly anticipated final guidance document on remanufacturing medical devices. This document aims to delineate the distinctions between "remanufacturing" and "repair" of a device. These activities are subject to significantly different regulatory requirements. The guidance addresses concerns, particularly among large medical device companies, regarding third-party servicing of devices. There will be a new webinar on June 27 focusing on the FDA's final remanufacturing guidance document. 💉 Read our breakdown:
The FDA, EPA, and USDA have jointly released a new "regulatory plan for biotechnology" in response to Executive Order 14081. Upon closer examination, the plan largely encompasses initiatives that the FDA was already committed to under existing efforts, such as user fee commitments and legislative requirements in the life sciences domain. Notably, the plan introduces a new FDA/EPA/USDA "pilot project" aimed at exploring the development of a web tool to clarify the regulatory oversight of biotechnology products. 💊
FDA General
The FDA has announced the qualification of a new Medical Device Development Tool for Atrial Fibrillation. This tool is the Apple Watch PPG Sensor, which utilizes green LEDs in conjunction with light-sensitive photodiodes to detect changes in blood flow through a user's wrist. By monitoring this data, the Watch can estimate the duration of time spent in AFib during the previous week of wear. FDA's qualification of this tool means it can be utilized as a biomarker test to support certain devices. 💉
The FDA is piloting a program aimed at improving communication between drug manufacturers, investigators, and its drug shortage team during inspections. The goal is to prevent facilities from needlessly shutting down, which could exacerbate shortages of essential drugs. This initiative was announced by Patrizia Cavazzoni, MD, director of the agency's Center for Drug Evaluation and Research (CDER). 💊
The FDA has released an updated list of all artificial intelligence and machine learning-enabled medical devices. This update includes the addition of 191 devices, marking a significant expansion.
The FDA has issued a "dear colleague" letter concerning PDUFA user fee invoices scheduled for distribution in August 2024, pertaining to fees payable in FY 2025. Companies are asked to provide updated information on key company contacts, product lists, and products listed in the Orange Book. 💊
In a recent interview, Sarah Yim, the head of biologics and biosimilars for CDER, discussed the topic of switching between biosimilars and their reference counterparts. Yim highlighted the significant point that there is "zero difference" and "no statistically significant differences" between biosimilars and interchangeable products. 💊
A new meeting announcement has been made regarding a "midway checkpoint" for the Drug Supply Chain Security Act (DSCSA). Currently, the DSCSA is undergoing a one-year "stabilization" delay to assist companies in complying with the enhanced supply chain provisions of the 2013 law. 💊
CDRHNew, the daily email bulletin of the CDRH, announced an update to its Collaborative Communities webpage. This platform allows CDRH representatives to engage in externally managed projects to address regulatory challenges. The goal is to broaden CDRH's research and project portfolios in key device areas while conserving its resources. It also allows real-world stakeholders such as clinicians, scientists, and device developers to share how regulatory or scientific challenges affect them and propose potential solutions. Upon reviewing the webpage, CDRH appears to be participating in three new Collaborative Communities. 💉
CDRH issued two organizational announcements regarding the structures of its Office of Product Evaluation and Quality (OPEQ) and Office of Communication and Education (OCE). These changes went into effect earlier this year. 💉
The FDA has announced its intention to conduct testing on cannabidiol (CBD) and several of its metabolites. The aim is to determine drug exposure levels and resulting neurochemical changes across various stages of brain development (perinatal, juvenile, and adult) in rats. This will involve administering CBD and its metabolites to nonclinical animal models at exposure levels relevant to humans. State-of-the-art imaging technologies with spatial resolution capabilities will be used in this research. 💊
FDA is convening a meeting in June of its Psychopharmacologic Drugs Advisory Committee, with a focus on Lykos Therapeutics' new drug application for midomafetamine (MDMA) for the treatment of post-traumatic stress disorder. The committee will evaluate the overall benefit-risk profile of MDMA, including its potential public health impact. 💊
A new set of FDA FOIA logs covering the month of April 2024 has been released.
The FDA and NIH have issued a request for information regarding the development of a resource on terminology for clinical research. They highlight a lack of consistency in the usage of certain terms across the clinical research ecosystem, particularly concerning descriptions of innovative clinical trial designs and studies utilizing real-world data (RWD) to generate real-world evidence (RWE). A working group from FDA-NIH has formulated definitions for 37 terms and is seeking feedback on 29 of them. 💊
The FDA intends to renew a $7.5 million grant to support a program aimed at enhancing the quality and efficiency of clinical trials. This initiative is collaboratively managed by the Duke Clinical Research Institute (DCRI) and the Clinical Trials Transformation Initiative (CTTI). 💊
In March 2024, the FDA approved 48 generic drugs, among which 2 were approved for the first time. Additionally, 13 products were approved on a tentative basis. 💊
The FDA responded to a 2009 Citizen Petition from Kaiser Permanente, which had urged the regulator to modify its approach to REMS plans for certain drugs. The petition requested various changes, including allowing public comment on proposed Elements to Assure Safe Use (ETASU), making summary data from REMS programs public, regularly evaluating ETASU elements, preventing preferential treatment to certain healthcare providers, and safeguarding the confidentiality of protected health information collected under a REMS. Over the past 15 years, the FDA has implemented many of the requested changes. However, it declined certain requests, such as allowing public comment on every ETASU before approval, publicizing summary data for all REMS plans, and mandating FDA review of business contracts between sponsors and healthcare entities. 💊
The FDA has scheduled a new meeting to delve into the current utilization of ketamine for emerging therapeutic areas. While ketamine isn't yet approved for conditions like depression or chronic pain, there's growing interest in its potential use for such conditions. The meeting aims to explore various aspects, including the scope of ketamine use, potential safety concerns, and online promotion and access to ketamine. 💊
Governing
Senator J.D. Vance (R-Ohio) and Representative Debbie Lesko (R-Ariz.) have introduced new legislation aimed at prohibiting federal employees working at the FDA from serving as board members or officers at life sciences companies post-government employment. Additionally, the legislation would prevent employees who approved a drug or product from profiting from those products and would impose new disclosure requirements for the spouses of FDA employees who own stakes in patents or covered products.
A new Senate companion bill has been introduced to accompany proposed House legislation affecting the dietary supplement industry. Among its provisions, the bill would prohibit various actions, such as the introduction of products marketed as dietary supplements into interstate commerce if they don't meet the dietary supplement definition. Additionally, it would bar debarred individuals from involvement in the packing or preparation of supplements. Notably, the bill doesn't specifically mention tianeptine at all. 💊
Senate Majority Leader Chuck Schumer (D-N.Y.) and other senators have reintroduced the Cannabis Administration and Opportunity Act, aiming to "end the federal prohibition of cannabis." The bill has significant implications for the FDA, as it proposes establishing a Center for Cannabis Products within the agency and directs the FDA to set standards for cannabis products and their labeling. 💊
The Congressional Research Service (CRS) has conducted an analysis on the legal implications of the DEA's potential decision to reclassify marijuana as a Schedule III substance under the Controlled Substances Act. Interestingly, the main implications would be FDA-related, as Schedule III substances require FDA approval as prescription drug products. 💊
Rep. Clay Higgins (R-La.) has introduced new legislation aimed at addressing "mass comments and computer-generated comments" in the regulatory review process. The proposed bill would mandate the Office of Management and Budget to verify, to the greatest extent possible, whether human beings submit comments at the time of submission. Additionally, agencies would be instructed to group mass comments together.
House Committee on Oversight and Accountability Chairman James Comer (R-Ky.) has sent a new letter to the FDA as part of a "government-wide investigation into the Chinese Communist Party's (CCP) ongoing efforts to target, influence, and infiltrate every sector and community in the United States." The letter outlines various concerns, including the lack of FDA inspections in China, the potential risk of FDA inspectors being detained under Chinese Counter-Espionage Laws, the possibility of security-motivated shortages and supply chain disruptions, and worries regarding data integrity. Additionally, the letter contains an extensive list of questions that the FDA must answer by May 13, 2024.
The Old Drugs, New Cures Act is a new legislation introduced to exempt "priority research" drugs from being classified as "line extension" drugs. This exemption aims to shield them from Medicaid drug pricing regulations, thus facilitating their access and affordability. 💊
Compliance and Enforcement
Kaiser Health News has reported that the FDA had never inspected a medical device company's production facility, despite the company manufacturing a jaw expansion medical device for over a decade. The device is now alleged to have harmed patients and is the subject of a criminal investigation, prompting concerns about the adequacy of FDA oversight. 💉
The FDA has issued a new letter to healthcare providers cautioning them about "continued safety and quality concerns" associated with specific cardiovascular devices manufactured by Getinge and Maquet. The letter advises providers to "transition away from use of these devices and seek alternatives, if possible." 💉
A rare recall has been issued for a diabetes mobile app that controls an insulin pump. The notice indicates a software issue causing pump battery depletion. 💉
The FDA has issued a Complete Response Letter to Dynavax for its supplemental application for approval for its hepatitis B vaccine. The letter cited destroyed data source documents by a third-party clinical trial site operator as the rationale for the CRL. 💊
Other
Friends of Cancer Research and assay developers have conducted new research on circulating tumor DNA (ctDNA), which is gaining attention as a predictive biomarker for assessing the effectiveness of treatments in certain cancers. The abstract notes that there's limited study on the heterogeneity of ctDNA levels before treatment (baseline) across different cancer types and stages and across ctDNA assays. The research evaluated baseline ctDNA levels across five cancer types in early- and late-stage disease, providing data to support ctDNA's potential as a biomarker for these cancer types. 💊