By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Health Works CollectiveHealth Works CollectiveHealth Works Collective
  • Health
    • Mental Health
    Health
    Healthcare organizations are operating on slimmer profit margins than ever. One report in August showed that they are even lower than the beginning of the…
    Show More
    Top News
    headphones can create health problems
    The Harmful Health Effects of Using Headphones
    September 24, 2021
    Headache causes
    4 Causes Of Headache You Probably Didn’t Know About
    December 28, 2021
    follow these steps to recover from your injury
    What Steps Should You Take to Recover More Quickly from an Injury?
    April 12, 2022
    Latest News
    5 Steps to a Promising Career as a Healthcare Administrator
    August 3, 2025
    Why Custom Telemedicine Apps Outperform Off‑the‑Shelf Solutions
    July 20, 2025
    How Probate Planning Shapes the Future of Your Estate and Family Care
    July 17, 2025
    Beyond Nutrition: Everyday Foods That Support Whole-Body Health
    June 15, 2025
  • Policy and Law
    • Global Healthcare
    • Medical Ethics
    Policy and Law
    Get the latest updates about Insurance policies and Laws in the Healthcare industry for different geographical locations.
    Show More
    Top News
    Contraception for Techno-Doctors
    July 13, 2011
    ACP Ethics Manual on Social Media, Catastrophes, and More
    January 13, 2012
    Hippocratic Oath, Then and Now
    August 23, 2012
    Latest News
    How IT and Marketing Teams Can Collaborate to Protect Patient Trust
    July 17, 2025
    How Health Choices and Legal Actions Intersect After an Injury
    July 17, 2025
    How communities and healthcare providers can address slip and fall injuries with legal awareness
    July 17, 2025
    Let Your Lawyer Handle the Work Before You Pay Medical Costs
    July 6, 2025
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: FDA Warning Letter Highlights Disconnect Between Regulator and Biotech Industry
Share
Notification Show More
Font ResizerAa
Health Works CollectiveHealth Works Collective
Font ResizerAa
Search
Follow US
  • About
  • Contact
  • Privacy
© 2023 HealthWorks Collective. All Rights Reserved.
Health Works Collective > Business > FDA Warning Letter Highlights Disconnect Between Regulator and Biotech Industry
BusinessNewsPolicy & Law

FDA Warning Letter Highlights Disconnect Between Regulator and Biotech Industry

StevenShie
StevenShie
Share
5 Min Read
SHARE

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).

FDA and 23andme

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.”

More Read

patient engagement
Person-Centered HealthCare BONUS!: A New Level of Patient Engagement
The Bionic Man Makes History in Mind-Controlled Prosthetics
Must-Have First Aid Essentials for Every Campbelltown Home
Medicare Data Access Provides Payment Transparency
Weekly Dose of Top 5 Healthcare Stories You Might’ve Missed

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.

TAGGED:23andMe
Share This Article
Facebook Copy Link Print
Share

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

technology in medical research
The Tools Helping Medical Researchers See the Full Picture
News Technology
August 3, 2025
5 Steps to a Promising Career as a Healthcare Administrator
5 Steps to a Promising Career as a Healthcare Administrator
Health
July 31, 2025
holistic dental
Holistic Dentist Services Are Natural and Safe
Dental health Specialties
July 28, 2025
botox certification
Help Improve People’s Skin Health Via Botox Certification
Skin Specialties
July 22, 2025

You Might also Like

Policy & Law

MTBI Testing Helps Get Settlements to Cover Medical Bills

April 15, 2024
partner and prosper
BusinesseHealth

5 (More) Ways to Wake Up Your Underachieving Website

April 4, 2014
BusinessTechnology

Leveraging Digital Signage for Patient Education,Marketing and Service Improvement

December 21, 2012

Hospital Infection Rates Decreasing

November 8, 2011
Subscribe
Subscribe to our newsletter to get our newest articles instantly!
Follow US
© 2008-2025 HealthWorks Collective. All Rights Reserved.
  • About
  • Contact
  • Privacy
Welcome Back!

Sign in to your account

Username or Email Address
Password

Lost your password?