FDA Warning Letter Highlights Disconnect Between Regulator and Biotech Industry

A surprise at this year’s Thanksgiving dinner was that a majority of my friends (who do not work in biopharma) at the dinner table heard about the FDA warning letter issued to 23 & Me, a biotechnology company that offers a direct-to-consumer genome test kit. Almost all of them have used the kit and find the results at least very entertaining (if not medically informative).

A surprise at this year’s Thanksgiving dinner was that a majority of my friends (who do not work in biopharma) at the dinner table heard about the FDA warning letter issued to 23 & Me, a biotechnology company that offers a direct-to-consumer genome test kit. Almost all of them have used the kit and find the results at least very entertaining (if not medically informative).

Photo credit: http://bit.ly/1bEzNPq

What amazed me the most from our discussion accompanied by juicy turkey and Argentina wine is the far-reaching effect of gene technology on regular consumers and the urgency for policymakers to address the disconnect between the ever-changing biotechnology landscape and static regulations.

On November 22, the FDA issued a warning letter to 23 & Me requesting the company to halt marketing of the $99 genetic testing kit because it does not have marketing clearance for certain claims of the product. The agency also concerns the accuracy of testing results, noting a false positive indicator for breast cancer may “lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions.”

The FDA may have a point but a bigger question here is why the agency finally issued a warning letter after almost six years since the company started to sell the testing kit. Whether the testing kit poses risks to consumers as the FDA has suggested, the slow response from the agency indicates there is a lack of understanding of the biotechnology business by regulators.

Back in 2009, the FDA held a hearing on social media and pharma. The news quickly generated excitement among pharma marketers. Four years passed, while social media has made some significant changes in pharma from marketing to clinical studies, we are still waiting for the guidelines from the FDA.

As a person who deals with social media and digital and mobile technologies in the pharmaceutical business on a daily basis, I see firsthand how a lack of practical regulatory guidance under today’s context can negatively affect efficiency, medical innovation and ultimately patient outcomes. To that end, I do have sympathy for 23 & Me, a company that is widely regarded as innovative and refreshing.

While I do believe 23 & Me should have done a better job communicating with the FDA and some of the concerns raised by the agency do seem legit, what we are increasingly seeing is that the development in pharma and biotech has completely outgrown the making of laws that regulate the industry. For instance, the boundary between smartphone and medical device will probably disappear soon; medical apps have been increasingly used in clinical settings; self-reported data via social networks have been considered to be used in clinical studies and wearable and ingestible devices are creating a whole new area of medicine. To ensure developments and technologies that are safe and show clinical benefits quickly reach patients, we need regulations that are practical and applicable.

From the wide adoption of in-home disease testing, personal genome mapping to self-reported clinical data, we see the participation of patient in health and disease management has gradually shifted how we practice medicine. We will continue to see more health-related products designed for direct-to-consumer use. Regulators need to be prepared for this reality.

While 23 & Me is closely working with the FDA to address the agency’s concerns, the FDA should probably also prepare some answers to patients and the industry.