The quality community received a sobering reminder recently of the importance of their work when...
Earlier this summer, Glaxo Smith Kline announced a partnership with popular take-home DNA kit company 23andMe. The deal, which gives GSK four years of exclusive rights to 23andMe data for purposes of drug development, could very well usher in a new era of pharmaceutical research. GSK has gone all-in on this idea, investing $300 million in 23andMe in what is being called a separate agreement.
The deal is not without complications, though. While every 23andMe customer will have the opportunity to decline having their personal genetic information shared, consumer advocates have already raised a number of questions. As with many industries, customer data security is of prime importance, but the ethics of what remuneration customers can expect as both companies use their information for profit has also been mentioned.
The questions regarding 23andMe go further back than the recent partnership, though. For several years now the FDA has been trying to decide what, if any, regulatory requirements should be enforced on companies like 23andMe and their competitors in the home DNA kit market, but the FDA isn’t the only interested agency. In 2016, as the European Commission adopted the General Data Protection Regulation, 23andMe had to ensure compliance before the May 25, 2018 deadline. They were able to do so, but this requirement may only be the beginning of much more complicated regulatory expectations as the partnership with GSK develops.
For now, the partnership of GSK with 23andMe has the promise to provide researchers with a nearly unprecedented amount of data on genetic sequencing. The potential to research and develop a wide range of drugs could greatly help to reduce suffering and even cure disease. It is also a reminder, though, that the medical industry is constantly evolving, and both government agencies and private companies need to stay on the cutting edge in order to ensure quality and regulatory expectations provide adequate safety guidelines the patient.
If any of the recent changes have you wondering what your next steps should be, Medpoint can help. Our consultants have a wealth of experience in Medical Device, Pharmaceutical, and Biotechnology. Contact us for more information: hello@medpoint.com or 800.200.9292.
Sources:
http://www.pharmabiz.com/NewsDetails.aspx?aid=110224&sid=2
https://www.amplion.com/biomarker-trends/its-time-for-fda-to-act-on-ldts/
https://www.23andme.com/gdpr/?ph1=true
