6 Key Takeaways from the CDER's Drug Safety Priorities Report for Fiscal Year 2024
The FDA just released its annual drug safety report. Here's everything you need to know in a 3-minute read.
The FDA's Center for Drug Evaluation and Research (CDER) just released its tenth annual "Drug Safety Priorities" report for fiscal year 2024 (ending September 30). While labeled as "priorities," it's essentially a comprehensive year-in-review of all significant drug safety activities CDER undertook.
This report matters because it reveals the FDA's focus areas and how the agency is responding to emerging safety challenges. For pharma companies, it offers a window into what's catching regulatory attention and where future scrutiny might land.
Here are the most important takeaways we felt emerged from the report.
The big picture
CDER's approach to drug safety has expanded beyond traditional postmarket surveillance. The Center is now using artificial intelligence, monitoring social media for emerging trends, and developing sophisticated data analytics capabilities to detect safety signals earlier.
It’s also tackling several critical areas simultaneously:
The evolving overdose crisis (now involving multiple substances beyond opioids)
Contamination concerns (particularly nitrosamines and benzene)
Safe implementation of newer drug categories (like GLP-1 receptor agonists)
Compounded medication quality issues
Enhanced transparency in adverse event reporting and labeling changes
Here are the six developments we felt were worth noting.
1. The FDA is modernizing its safety surveillance capabilities
CDER established two new centers of excellence in 2024:
Quantitative Medicine Center of Excellence (QM CoE): Created in March 2024 to "enable and organize the continuous advancement and consistent use of quantitative medicine for drug development and regulatory decision-making." The center focuses on identifying and quantifying uncertainty earlier in a product's lifecycle and contributing to a fuller understanding of a drug's benefits and risks.
Center for Clinical Trial Innovation (C3TI): Established in April 2024 to "strengthen and expand innovative approaches to clinical trials designed to generate the needed evidence of safety and improve the efficiency and effectiveness of drug development."
The agency also announced the Emerging Drug Safety Technology Program (EDSTP) in June 2024. Through Emerging Drug Safety Technology Meetings (EDSTMs), the program facilitates conversations with the industry about AI and other emerging technologies for pharmacovigilance.
The FDA's electronic safety surveillance network, the Sentinel System, completed several signal identification analyses using tree-based scan statistics and published nine peer-reviewed papers in FY24. The agency also expanded the system by onboarding EHR data partners with structured data fields and linking claims data from commercial partners.
2. Addressing the evolving overdose crisis remains a top priority
The FDA has expanded its approach beyond prescription opioids to address the "multifaceted" polysubstance crisis. Despite a decrease in overdose deaths between 2023 and 2024, the agency noted that deaths still reached "more than 86,000" with continued threats from "polysubstance use and addiction."
Key activities in FY2024 included:
Launching the "Prescribe with Confidence" campaign in May 2024 to help primary care professionals recognize and treat opioid use disorder, addressing the lack of providers in rural communities.
Approving new overdose treatments, including a higher-dose naloxone intranasal spray (April 2024), a generic over-the-counter naloxone nasal spray (April 2024), and the first nalmefene hydrochloride auto-injector (Zurnai) for emergency treatment of opioid overdose (August 2024).
Hosting multiple public meetings on substances of concern, including "Mitigating Risks from Human Xylazine Exposure" (October 2023), "Advancing Psychedelic Clinical Study Design" (January-February 2024), and "Understanding Current Use of Ketamine for Emerging Areas of Therapeutic Interest" (June 2024).
Publishing the draft guidance "Stimulant Use Disorders: Developing Drugs for Treatment" (October 2023).
Implementing required labeling updates for opioid analgesics and urging healthcare professionals to take a more "patient-centered approach" when prescribing (December 2023).
Holding Tribal Listening Sessions on high-dose buprenorphine to treat opioid use disorder in the context of fentanyl (November 2023).
Funding the American Society of Addiction Medicine's draft "Clinical Practice Guideline on Benzodiazepine Tapering" (June 2024).
3. Medication quality concerns continue to drive regulatory action
In FY24, the FDA intensified efforts to protect the public from impurities and contaminants in medications:
Released two critical guidance documents: "Reformulating Drug Products That Contain Carbomers Manufactured With Benzene" provides recommendations for tests and documentation needed to support reformulating products using carbomers manufactured with benzene. "Control of Nitrosamine Impurities in Human Drugs" updates the agency's "thinking about how drug companies can detect and prevent unacceptable levels of nitrosamine impurities."
Conducted extensive N-nitrosamine research to:
Address knowledge gaps regarding suitable antioxidants to mitigate N-nitrosamine formation.
Assess the effect of certain excipients in metformin products on NDMA formation during manufacturing.
Develop analytical methods to detect nitrosamine drug substance-related impurities (NDSRIs) across drug products.
Study how secondary amine drug substances might support NDSRI formation.
Evaluate assays to assess the potential of N-nitrosamine impurities to cause genetic damage.
Two CDER-funded research studies found evidence that generics could potentially be reformulated with antioxidants to mitigate N-nitrosamine impurities "without altering the BA/BE of a generic product." This research directly supported advice in the latest nitrosamine guidance.
4. GLP-1 receptor agonists are under close safety monitoring
With the dramatic uptake of GLP-1 receptor agonists (GLP-1 RAs) for diabetes and weight management, the FDA is closely monitoring safety signals and utilization patterns.
In January 2024, the agency issued a Drug Safety Communication on "reports of suicidal thoughts or actions" in patients taking these medications, stating their "preliminary evaluation did not find evidence" of causation but noting they "could not definitively rule out that a small risk may exist."
Drug utilization analyses showed "substantial uptake" of GLP-1 RAs and suggested off-label use, providing "insight into possible reasons behind medication shortages."
The agency also raised specific concerns about compounded versions of semaglutide:
It issued letters to the National Association of Boards of Pharmacy and Federation of State Medical Boards in October 2023 expressing concerns with salt forms in compounded medications and explaining conditions when compounded semaglutide products might be legally permissible. Read the NYTimes piece on this here.
It alerted healthcare professionals and patients in July 2024 about dosing errors with compounded injectable semaglutide products.
It warned consumers in December 2023 not to use counterfeit Ozempic found in the US drug supply chain and updated the web page on "Concerns with Unapproved GLP-1 Drugs Used for Weight Loss."
5. Risk communication strategies are evolving with digital emphasis
CDER has expanded its communication strategies to reach audiences where they already engage:
It released four Drug Safety Communications (DSCs) in FY24 that generated over 210,000 unique views:
Levetiracetam and clobazam (risk of DRESS)
GLP-1 RAs (ongoing evaluation of suicidal thoughts)
Denosumab (adding a Boxed Warning for hypocalcemia risks in CKD patients)
Fezolinetant (liver injury risk)
It significantly expanded social media presence with:
Over 990 posts on X (formerly Twitter)
555 posts on LinkedIn
325 posts on Facebook
90 posts on Threads
60 posts on Instagram
A new @FDACDERDirector account on X with over 3,500 followers, including media outlets and healthcare leaders
It approved 6,014 safety-related labeling changes, including:
1,228 Warnings and Precautions updates
1,148 Adverse Reactions updates
1,140 Patient Counseling/Medication Guide updates
1,020 Use in Specific Populations changes
634 Drug Interactions updates
478 Contraindications updates
366 Boxed Warnings (FDA's most severe warning type)
It enhanced online communication with:
41.5 million individual sessions on CDER web pages
Four Drug Safety Podcasts generating over 57,000 engagements
Web analytics showing visitors spent an average of 36 seconds viewing DSC information
41,658 responses to public inquiries via phone, email, letters, and social media
6. Compounded medications face increased scrutiny following safety concerns
CDER also intensified oversight of compounded drugs and facilities in response to safety issues:
It issued six warning letters, one untitled letter to compounding facilities, and 10 state referral letters.
It published two draft guidance documents in December 2023 describing interim policies on bulk drug substances in compounding while developing required lists:
It issued the proposed rule "Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding" in March 2024, which would establish criteria and codify three categories of drugs that present such difficulties:
Oral solid modified-release drug products employing coated systems
Liposome drug products
Drug products produced using hot melt extrusion
It released multiple safety alerts:
It held the 12th Inter-governmental Working Meeting on Drug Compounding with state regulators (November 2023) and the FDA 2024 Compounding Quality Center of Excellence Annual Conference (August 2024).
What this means for pharma
This report signals the FDA's direction and emphasis for the coming year. For pharma firms, several implications emerge:
Expect more sophisticated safety monitoring. The FDA's investment in advanced analytics, AI, and social media monitoring means potential safety signals may be detected earlier and from non-traditional sources.
Proactively address risk communications. With the FDA's expanded communication channels reaching millions, companies should prepare rapid response strategies for any safety communications affecting their products.
Stay vigilant on manufacturing quality. The continued focus on nitrosamines and other impurities suggests ongoing scrutiny of manufacturing processes and quality control.
Prepare for increased focus on abuse potential. The agency's expanded approach to substance abuse monitoring may affect how drugs with CNS effects are evaluated, labeled, and monitored postmarket.
Anticipate more requirements around innovative therapies. Novel drug categories experiencing rapid uptake (like GLP-1 RAs) can expect heightened postmarket surveillance requirements.
Who is The FDA Group?
The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on Quality Assurance, Regulatory Affairs, and Clinical Operations.
With thousands of resources worldwide, hundreds of whom are former FDA, we meet your precise resourcing needs through a fast, convenient talent selection process supported by a Total Quality Guarantee. Learn more and schedule a call with us to see if we’re a fit to help you access specialized professionals and execute your projects on time and on budget.