The FDA and 23andMe: The Challenge of Open Access to Genetic Information

December 17, 2013

23andmeA variety of online and other information sources, such as the company 23andMe, offer consumers access to increasingly sophisticated information regarding their personal genomic structure.  This information access has led regulatory authorities such as the Food and Drug Administration (FDA) to examine the extent to which these personal genome information services should be regulated.  The FDA is currently reviewing these services and is likely to issues guidance in the near future.

The Personal Genome Service (PGS) offered by 23andMe is an example of the increasingly sophisticated genome information analysis now routinely available to individual consumers.  PGS and other similar services provide individuals with access to their personal genetic data.

Few dispute the appropriateness of enabling individuals to identify and review their personal genome information.  Regulatory questions arise, however, with regard to the accuracy of that information and the ways in which the information is used by consumers.

Critics of personal genome services contend that providers of the information are no longer presenting the data purely in the context of information, research, and education.  Instead, they claim that personal genome service providers are beginning to suggest that the genome information can be used directly by consumers for health and medical purposes.

Some observers are concerned that individual consumers will misinterpret their genome information, using that information for inappropriate and potentially harmful purposes.  They fear, for example, that people may choose medical therapies or procedures based on misinterpretation of their genome information.  They are also concerned that individuals may alter or abandon medical treatments based on misunderstanding of their genomic information.

Supporters of open access to personal genome information argue that the service providers continue to express clearly the limits of the information they provide.  They contend that individuals should have direct access to the best available information regarding their bodies and health.  The supporters of personal genome services note that these services are presented as information services, not health recommendations.

The FDA is currently reviewing PGS and similar services.  It is attempting to determine whether those services are, in fact, being marketed as health recommendations and if so how those recommendations should be regulated.  Pending completion of it review, the FDA ordered personal genome service providers to cease marketing to new customers, and to limit current customers to access to their raw genome data only, while providing no interpretation of that data.

The regulatory challenges associated with access to personal genome information are similar to those associated with open access to a variety of other forms of data.  In each instance, there is clear value associated with providing the data access.  There are, however, equally clear public interest concerns with regard to the accuracy and appropriate use of the data.

For personal genome services and the vast majority of other forms of information and data, the benefits of open access appear to outweigh the associated costs and risks.  The key challenge faced by regulatory authorities is creation of an oversight framework that facilitates public access to the benefits of the information while minimizing the risk of its misuse.