RA/QA News Roll: Late December 2023
Here's what's happening at FDA and across the broader life science RA/QA space.
In the spirit of holiday giving, this issue is free to all subscribers!
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.
We’re bringing this issue to you a week early to take a break during the holiday. We’ll cover any news that appears during that time in our first January news roll.
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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.
Here are some key items from the past couple of weeks.
FDA Guidances and Related Documents
A substantial collection of new guidance documents has been announced in today's Federal Register. These documents cover a range of topics, including Master Protocols, Digital Health Technologies for Remote Data Acquisition, Real-World Data Registries, and Real-World Data Standards for Drug and Biologics.
The FDA and the EMA have issued joint guidance on streamlining quality development for FDA's Breakthrough Therapies and EMA's PRIME Programs. This guidance primarily aims to assist companies participating in these expedited programs in enhancing their readiness concerning quality and manufacturing specifications within their applications. As FDA regulators emphasize, while an application may have excellent data, if a company cannot demonstrate reliable drug manufacturing, approval may be hindered. 💊
A new FDA draft guidance provides recommendations regarding the FDA's 510(k) Third Party Review Program and Third-Party Emergency Use Authorization Review. These programs enable non-FDA personnel to conduct product reviews, potentially expediting the process by pre-screening products for quality before the FDA's final evaluation. 💉
A revised CBER Operating Procedure (SOPP) for Administrative Processing and Review Management Procedures for Investigational New Drug Applications now includes best practices for issuing Interim Responses (IRs) no later than day 21 in cases of potential hold issues, subject to resource availability. Additionally, extra reviewers have been added to the review team. 💊
Yet another revised CBER SOPP for the Review of Proprietary Names for CBER Regulated Products now includes new language specifying that if a proprietary name review (PNR) request is submitted with a rolling application, the review clock will commence upon receipt of the final module. Additionally, the SOPP has been updated to align with current processes. 💊
The FDA's Office of the Chief Scientist has published a new Guidance Agenda webpage, which notably includes two advisory committee-related guidance documents: "Conflicts of Interest and Eligibility for Participation in FDA Advisory Committees" and "Appearance Concerns and Authorizations for Participation in FDA Advisory Committees." While the issues they address are not new, these guidance documents may be new or revised. This development coincides with ongoing reforms to the FDA's advisory committee system, with Namanjé Bumpus, FDA's Chief Scientist and incoming Principal Deputy Commissioner, playing a leading role in these reforms.
FDA General
Robert Califf's latest blog post explains a new final rule released by the agency, aimed at streamlining medical product development. According to Califf, the rule grants an exception from the informed consent requirement for clinical investigations that pose minimal risk to participants, provided that appropriate safeguards are in place to protect their rights, safety, and welfare.
Starting on January 22, CDER and CBER will broaden their in-person, face-to-face industry meetings to encompass all meeting types related to PDUFA, BsUFA, and OMUFA. Notably, the expansion excludes GDUFA meetings from this list.
The FDA's CBER has released a list of 25 regenerative medicine development standards that it recognizes. Among these standards, one is partially recognized, while the others receive full recognition. These standards are designed to assist cell and gene therapy companies in facilitating the market entry of their products by relying on FDA-recognized standards, which are developed more expediently by standards development organizations. The FDA had previously issued guidance on the process for publishing these standards earlier this year. 💊
CDRH has announced its participation in three new collaborative communities: the AI Global Healthcare Initiative, Infection Management Collaborative community, and the Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD). Through the Collaborative Community model, the FDA can engage in various projects on medical device policy topics by participating in existing working groups without necessarily leading them, thus allowing the agency to address a wide range of issues where resources or a global perspective may be lacking. Among these communities, SHIELD stands out, as it focuses on laboratory data interoperability, offering insights into how to consider real-world data (RWD) and evidence for tests and diagnostics, which represents a significant gap in the current RWD system. SHIELD's expertise in this area will enable CDRH and the FDA better to understand the data landscape and potential regulatory solutions. 💉
Governing
Senate Health, Education, Labor and Pensions (HELP) Committee ranking member Bill Cassidy (R-LA) is urging Congress to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA). This legislation lapsed several months ago when it did not receive full Senate or House approval. It is worth noting that this legislation is essential for the reauthorization of the FDA's Material Threat Medical Countermeasure Priority Review Voucher program, which is currently unable to issue new vouchers without it. 💊
Senator Elizabeth Warren (D-MA) and Representative Pramila Jayapal (D-WA) have issued an extensive letter to eight pharmaceutical companies, expressing Federal Trade Commission (FTC) concerns regarding the listing of certain prohibited patents in the FDA's "Orange Book." The Orange Book is a crucial database containing information about drugs, their generic counterparts, and controlling patents. The lawmakers have called on these pharmaceutical companies to remove the improperly listed patents from the Orange Book by December 16 and respond to their inquiries by no later than January 15, 2024. 💊
Compliance and Enforcement
The FDA issued a Complete Response Letter (CRL) to Checkpoint Therapeutics regarding alleged manufacturing issues concerning cosibelimab, a drug designed for the treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC") who are not eligible for curative surgery or radiation. Checkpoint has stated that the problems were observed at a third-party manufacturer and that no other issues were identified. 💊
A drug manufacturer and distributor based in Massachusetts has received an order from the FDA to cease drug distribution until the company aligns with the FD&C Act and fulfills other conditions outlined in a consent decree. Over the past five years, the FDA has identified significant issues at the company, including a failure to investigate major product failures. 💊
Three high-ranking Republicans, including Cathy McMorris Rodgers, H. Morgan Griffith, and Brett Guthrie, have sent a follow-up letter to the FDA concerning the agency's foreign drug inspection program. The legislators contend that the FDA has not responded to previous inquiries from the Committee, despite having been asked to provide responses in July 2023. Citing a Bloomberg report that the FDA discontinued its unannounced foreign inspection program due to concerns that it hindered collaboration with India, the letter expresses frustration. The FDA faces potential subpoenas if it does not respond to this latest letter, which includes an extensive list of requests, by January 5.
Nine Senate Republicans have also written a letter expressing concerns about the FDA's foreign inspections, particularly emphasizing the disparities in inspection rates between U.S. and foreign facilities. The letter includes a noteworthy quote, stating that "FDA's inspection records show a clear and perverse disparity. In effect, the FDA is treating American producers as if they are orders of magnitude more risky than foreign producers when the opposite is plainly true." The letter also alleges that there were no FDA inspections of foreign medical device manufacturers in 2022. 💉
Other
The EMA in Amsterdam is facing the prospect of an unwelcome new neighbor—a planned “erotic center” located approximately 500 meters away, intended to centralize much of the city's "Red Light" district. EMA employees have raised concerns about the potential discomfort of international regulatory colleagues when traveling to and from the agency's headquarters.
Bloomberg Law published a report revealing that the FDA has taken limited action to address misleading drug claims on social media, despite possessing the authority to regulate prescription drug marketing. The report specifically highlights the Office of Prescription Drug Promotion (OPDP), which has issued only a small number of warnings since 2017, none of which reference TikTok. Additionally, only seven of these letters have mentioned Facebook, Instagram, or YouTube. 💊
A new FDA and CMS staff analysis compares "two assessments of real-world data and real-world evidence for regulatory decision-making" — identifying variations in the definitions of real-world data across different regulatory bodies.
Kaiser Health News has published a report highlighting what it perceives as "deep flaws in FDA oversight of medical devices." The report primarily centers on the perceived shortcomings of the 510(k) premarket notification system. It also raises concerns about the challenges the FDA encounters in tracking device safety events once products are on the market. 💉
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