Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies.
FDA Combines All Adverse Event Reporting Systems into One Public Dashboard
What is happening: FDA announced on March 11, 2026 that it is creating a single publicly accessible dashboard to allow stakeholders to search adverse events for all regulated products, accomplishing one of Commissioner Marty Makary’s goals upon arriving at the agency last spring. The announcement notes that the unified dashboard, called the Adverse Event Monitoring System (AEMS), currently contains new and legacy adverse event reports for drugs, biologics, vaccines, cosmetics, and animal food; however, as of the date of this publication, no data relating to animal drugs or food appear to be available. The Vaccine Adverse Event Reporting System (VAERS), which is jointly managed by FDA and the Centers for Disease Control and Prevention (CDC) will remain operational, but FDA will incorporate VAERS data into AEMS. The agency plans to add adverse event information for the remaining regulated product types — namely medical devices, food (including dietary supplements), and tobacco products — to AEMS and to start adding event report data in real time by the end of May 2026.
The user interface for the new AEMS dashboard looks almost identical to the now-retired FDA Adverse Event Reporting System (FAERS) dashboard, displaying aggregate per-year adverse event data that can be further explored or searched for specific product and event data. The only major difference currently is that the user may select data specific to “Drugs and Biologics,” “Cosmetics,” or “Vaccines” from tabs at the top of the interface.
Why it matters: A unified adverse event reporting system facilitates public access to data coming in to FDA by creating a single access point for users. By eliminating multiple web-based platforms, FDA will need to maintain only one reporting platform once it migrates all product adverse event data to AEMS, which, according to the agency, will save approximately $120 million over five years.
Access to “real-time” adverse event data may permit safety signal trends to be identified earlier, which could in turn lead to more efficient manufacturer corrective actions (or quicker agency enforcement action) to prevent further harm to patients or the public health. However, publishing adverse event data as soon as possible without initial review may distort safety signals because voluntary reports submitted by health care professionals or patients may be unverified, such that the reported event could be unrelated to the medical product. FDA addresses this concern with disclaimers explaining the limitations of the data whenever a user accesses a product tab on AEMS.
Who may be affected: All FDA-regulated product industries and their constituencies will be impacted by the adverse event reporting system changes that provide easier access to raw product safety information. On the one hand, AEMS offers manufacturers a clearer picture of product safety in the field and, in combination with their internal quality assurance systems, may permit more accurate trending and responses to safety signals. On the other hand, patients and health care professionals may make health care decisions based on “real-time” safety information from AEMS. Use of an important medical product could decrease if it accumulates reports of serious harm or death on AEMS, even if the reports are unverified and the events are in fact unrelated to the product itself. In addition, product liability attorneys could attempt to build lawsuits against manufacturers over “real-time” trending information.
Importantly, although AEMS changes the way in which the public accesses safety data maintained by FDA, the reporting processes for adverse events remain unchanged (whether mandatory on the part of industry members or voluntarily submitted by consumers).
Final Rule to Modernize NDC System Provides 7-Year Implementation Period, 3-Year Transition Period
What is happening: Culminating a multi-year stakeholder consultation and rulemaking effort, FDA issued a final rule entitled “Revising the National Drug Code Format and Drug Label Barcode Requirements” on March 4, 2026. National Drug Codes (NDCs) are critical to the US health care ecosystem, with providers and payors alike utilizing these unique identifiers that are assigned to each package size of an individual drug product. NDCs also facilitate drug recalls and are built into the electronic identifiers required under the Drug Supply Chain Security Act (DSCSA).
- The final rule ushers in a new, standardized system in which all NDCs will consist of 12 digits; for historical reasons, manufacturers today label their drugs with either 10-digit or 11-digit codes, creating potential for confusion, product mix-up, or data loss.
- On March 7, 2033, the final rule’s effective date, FDA will convert existing NDCs into the 12-digit format by adding leading zeros wherever needed, thereby allowing manufacturers to keep their existing labeler codes, product codes, and package codes (three elements that, together, comprise a product’s unique NDC). The agency explains that it will be responsible for those conversions and for updating drug listing files accordingly, meaning that manufacturers will not be required to withdraw and resubmit drug listings for their commercial products following the conversion.
- FDA also points out explicitly that it “does not view conversion of a 10-digit NDC to a 12-digit NDC as resulting in a ‘new’ NDC” and that “nothing in this final rule requires a change to the NDC format used for purposes of claiming or disputing historical claims for Medicaid drug rebates” — reasoning that could apply broadly to many other settings that rely upon the inclusion of NDC numbers.
Due to the complexity associated with US health care facilities, insurers, government agencies, and other stakeholders updating their systems to allow for the use of 12-digit NDCs, FDA has given drug manufacturers seven years to implement the changes and update drug product labeling (including barcodes and product identifiers mandated by the DSCSA). In the interim, all affected entities should work toward transitioning their electronic systems and other infrastructure to ensure that the new codes will be adopted successfully. Following the implementation period, FDA has stated that it intends to exercise enforcement discretion for three years, during which it will not take action against a drug that is labeled with its “old” NDC number as long as the drug was first distributed in commerce before March 7, 2033.
Who may be affected: All health care stakeholders will be affected by this upcoming planned standardization of the country’s uniform drug coding system. Every entity should take appropriate steps to ensure it is ready to adapt to the new 12-digit NDC system in order to continue interoperability across the pharmaceutical supply chain as well as at the point of patients’ access to prescription drug products.
At the same time, due to the three-year transition period that will follow the final rule’s March 2033 effective date, wholesalers, dispensers, and insurance companies (among others) will likely be engaging in transactions that involve both old 10/11-digit NDCs and new 12-digit NDCs. That temporary overlap further complicates the adoption of updated electronic systems, which until March 2036 will need to accommodate more than simply a longer code, and may increase implementation or operational costs for certain stakeholders involved in health care delivery.
Importantly, NDC numbers also apply to animal drugs, such that the final rule’s changes will also impact animal drug manufacturers and wholesalers, veterinarians, and insurers that cover veterinary services and products.
Enhanced Scrutiny of DTC Prescription Drug Advertising Ensnares More Telehealth Firms
What is happening: FDA issued a press release on March 3, 2026 to highlight the public posting of more than two dozen warning letters it sent to various telehealth companies in late February, an action widely seen as a continuation of the agency’s self-declared “crackdown” on direct-to-consumer (DTC) drug advertising that began in September 2025. The warning letters object to specific marketing claims used to advertise the compounded drugs that each telehealth company makes available through its platform, primarily GLP-1 products used for weight loss and diabetes management. For example, FDA cited as false or misleading:
- claims stating or implying that compounded products are “generic” forms of FDA-approved drugs;
- claims that the compounded drugs contain the “same active ingredient” as FDA-approved drugs;
- claims that the compounded drugs being advertised are “clinically proven”; and
- imagery of compounded drug containers suggesting that the telehealth firm is the compounder/source of such products, even though it is not (i.e., consumers do not have visibility into which licensed pharmacies are preparing the drugs on behalf of the telehealth firm and its customers).
Why it matters: Many of these citations were seen in FDA’s September 2025 warning letter sweep to telehealth firms, which we discussed briefly in last month’s newsletter. However, the February 2026 batch of letters marks the first time the agency has publicly raised the assertion that images of drug labels prominently featuring the telehealth firm’s name/logo misbrands those drugs by (1) falsely representing that the telehealth firm is the compounder; and (2) appearing to omit required dispenser information.
To date, none of FDA’s telehealth company-directed letters has targeted the lawfulness of the compounded drugs themselves or their sources. In last month’s newsletter we highlighted a February 6 statement by Commissioner Makary indicating that the agency would “take decisive steps to restrict GLP-1 active pharmaceutical ingredients (APIs) intended for use in non-FDA-approved compounded drugs that are being mass-marketed by companies … as similar alternatives to FDA-approved drugs.” While there is clearly much more attention from the agency on marketing claims for such products, it has not yet taken any “decisive steps” toward restricting access to APIs or to compounded formulations that may not comply with applicable provisions of the Food, Drug, and Cosmetic Act.
Who may be affected: Telehealth companies wishing to avoid similar FDA correspondence and the downstream effects of such written objections should take proactive steps to review and revise any marketing content that may create similar misleading impressions. These latest warning letters — and the agency’s decision to issue a press release about them — suggest that DTC drug advertisements disseminated by the telehealth industry will continue receiving a high degree of scrutiny from FDA and potentially its enforcement partners, such as the Department of Justice.
FDA Warning Letter May Be First to Cite Violation of the Federal “Right to Try” Act
What is happening: FDA’s Center for Devices and Radiological Health (CDRH) issued a warning letter on February 6, 2026 to the CEO of ExThera Medical Corporation (ExThera) following a 2025 inspection of the company’s operations. ExThera is the sponsor of certain clinical research and compassionate use protocols for an unapproved device system; it was inspected by the agency to assess its adherence to Good Clinical Practices, data integrity standards, and other regulatory requirements.
Among other things, the warning letter highlights that ExThera distributed unapproved devices to hospitals without receiving FDA approval to do so under its open Investigational Device Exemption (IDE). In response to those observations, the company asserted that the “device can be distributed and used in certain states based on [its] compliance with Federal and state ‘Right to Try’ laws.” The agency flatly rejected that position, noting that the federal law in question “is not applicable to devices, and compliance with a state ‘Right to Try’ law that conflicts with applicable Federal law would not relieve your firm of compliance with Federal law.”
Why it matters: CDRH’s letter to ExThera appears to be the first time that the agency has mentioned the Federal Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, which was signed into law by President Trump during his first term, in a warning letter or other public notice of violation to a drug or medical device company. As public interest in investigational medical products continues to increase, developers may be under greater pressure to make such products available to patients and their health care providers. It is critical, however, for companies to ensure that they interpret and apply relevant laws correctly and that their operations are defensible and lawful.
The ExThera warning letter also includes important reminders about the risk of disseminating misleading or promotional statements about unapproved devices (both render the devices misbranded and adulterated), along with a reminder that FDA is reviewing multimedia content created or controlled by a product’s sponsor. For example, CDRH objected to statements made in a podcast featuring the company’s chief medical officer that implied the device was FDA-approved for marketing in the US.
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