The FDA announced its launch yesterday of an initiative called “openFDA,” which will allow a new and heightened level of public access to FDA-collected data and information, including drug adverse events, product recalls, and labelling information. While the initiative doesn’t change the scope of what is publicly available, it does provide a more efficient means for technological access to already publicly available information through a searchable online interface. It further invites developers to create new applications that can custom tailor and streamline relevant information to suit the research needs of companies as well as individual consumers.
It will be interesting to see what new projects and businesses unfold as a result of this initiative. Manufacturers will certainly want to find ways to utilize this technology to serve both their business development needs as well as to assist with identifying potential consumer safety issues and liability risks. Consumers, likewise, have an interest in utilizing this technology to educate themselves about products they use, though there is always the risk that if information is accessed without being properly understood, this could lead to misdirected advocacy or unfounded litigation. Companies – particularly in the drug and medical device industries – should consider developing strategies for anticipating how this information could be misused and tactics for mitigating adverse outcomes.
One potential starting point is for manufacturers to reevaluate their own mechanisms for public disclosures and communications. The FDA initiative could present an empowering opportunity for companies to manage and publicly respond to consumer safety concerns in real time as they are reported and become leaders in consumer education about new issues as they emerge. We will continue to monitor developments that stem from the openFDA launch with an eye toward identifying helpful policies for manufacturers to consider as well as pitfalls to be avoided.