New Open Access to FDA Data on Adverse Events - How Can the Industry Respond?
The United States' Food and Drug Administration (FDA) has announced that the agency has created a user-friendly forum providing free access to information received about adverse events. Reports made since 2004 are now available online. This is the first time that adverse event information received by the FDA’s Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS) has been made so readily accessible to consumers. This initiative is part of the openFDA project launched by the FDA.
What is an adverse event?
Adverse event data includes any reported minor, or major, negative reactions or complaints received from any source such as consumers themselves, without any independent verification or indication of conditions of use, other products used together with the product in question, medical conditions of the reporting party and the like. Claims to lack of efficacy can also be included in the database. The term adverse event is summarised by the FDA on their blog as "an umbrella term for a number of poor outcomes, including bad reactions, illnesses or deaths." Indeed, consumers and litigators accessing the information are rarely aware that reports are recorded without any assessment of the relationship of the product to the reaction, other products that may have been used, whether use was contrary to instructions, illnesses that the patient may have, concomitant medication use, or even whether the identification of the product is accurate. The FDA concedes that reports "vary in the quality and reliability of the information provided."
What is changing?
- Adverse event information was previously only available through Freedom of Information Act (FOIA) requests. FOIA requests took time to process. The FDA would have to check each report to exclude data that was not disclosable and the resulting reports were often cumbersome or impossible for a lay audience to review.
- Now adverse event information is immediately available online to the public through CAERS.
- New filings will be published quarterly.
- There is no change to the policy of providing no analysis or asking the company to respond. Provisos with regard to the potential invalidity of the data are not provided.
While reports are stated not to be indicative of a determination of fault by the FDA, the potential that data is misused or that the data may indeed be misleading to consumers may cause companies to consider the merit in:
- Continuing to file voluntary reports if that is being done (currently encouraged by the FDA); and
- Publicly commenting on any negative reports, which would then be included in the release, in order to manage potential reputational or liability issues. For instance, we would be happy to assist companies in the sector by monitoring reports in order to file disclaimers with regard to the inadequacy of the information as is now frequently done on blogs and chat rooms.
Please contact us if you would like additional information on the impact of this new policy.