By Riëtte van Laack –
This week, FDA announced (here and here) that it is making available adverse event information for foods (including dietary supplements, food additives, and color additives) and cosmetics the Agency has received through its Center for Food Safety and Nutrition (CFSAN) Adverse Event Reporting System (CAERS).
CAERS contains information on adverse event and product complaint reports submitted to FDA for foods and cosmetics. These adverse event reports come from consumers, health care providers, and food, cosmetic, and dietary supplement manufacturers. Since 2007, dietary supplement manufacturers have been required to report serious adverse events associated with the use of a dietary supplement. FDC Act § 761. Food manufacturers, cosmetic companies and others may submit reports voluntarily. CAERS includes any adverse events or complaints, including minor to major medical events, but also complaints about non-medical issues such as off-taste or color of a product. Information in the database includes demographic (e.g., age, gender) and administrative information regarding the adverse event; the date of event; the product role (“suspect” or “concomitant”); reported brand/product name; industry code/name; reported symptom(s); and outcome information. Unless it is included as part of the brand name, the data do not include the name of the manufacturer or distributor of the product.
Until now, the CAERS data have not been readily available to either industry or consumers. Anyone interested in obtaining such data on a specific product or ingredient had to submit a freedom of information (FOI) request (which may take months or longer before information is made available). However, FDA has decided to make available all of the data FDA has extracted from adverse event reports since January 2004 through September 2016, and, according to the announcement, FDA plans to issue quarterly reports going forward. There will be a lag phase of 1 month, i.e., the first quarterly report will be issued in Feb. 2017 and will cover data submitted to CAERS during Oct.-Dec. 2016. The second quarterly report will be issued in May 2017 and will cover reports submitted in Jan-Mar. 2017, and so on.
From now on, CAERS data are available to the public in three different ways:
- CAERS Data Files: provides raw data consisting of individual case safety reports extracted from the CAERS database.
- openFDA: provides an application program interface (API) for automated querying of the adverse event reports.
- by sending a FOI request to FDA
FDA has used and will continue to use CAERS data for activities such as looking for new safety concerns that might be related to a marketed product, evaluating a manufacturer's compliance with reporting regulations. The Agency’s clinical reviewers evaluate the report to identify signals of potential safety concerns (which may result in further action). FDA posted an interview with Linda Katz that specifically discusses FDA’s use of adverse event reports concerning cosmetics.
As FDA clarifies, CAERS data that FDA will make available are not evaluated before FDA releases them. The reports reflect information submitted. FDA does not edit the information (other than removing duplicates) and the reports do not represent any conclusion by FDA about whether the product actually caused the adverse events (e.g., the event may have simply occurred by chance at that time); it is information – not proof. The information submitted may not include all relevant data, such as whether an individual also suffered from other medical conditions or used other products or medications at the same time.
According to the notice, FDA is making “this information available for the purpose of improving transparency by providing the public, including researchers and health care professionals, with online access to information from adverse event reports about CFSAN-regulated products.” Apparently, FDA “anticipates that this increased transparency will help to spur the submission of more detailed and complete reports from consumers, health care providers and other members of the public” and “will help [FDA] to more rapidly identify red flags about a possible safety issue with products [FDA] regulate[s].” It remains to be seen if this will be a result. We are at least somewhat concerned that, despite the limitations identified by FDA, the information will be used by consumer class action plaintiff’s lawyers to identify the next potential targets for litigation.