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
    What Are the Benefits of CBD?
    November 27, 2021
    How to Measure Adult Diapers- The Ultimate Guide to Picking the Right Size
    March 8, 2022
    medicine cabinet
    The Effect Of Finished Dosage Form Manufacturing In New Drugs
    July 5, 2022
    Latest News
    Beyond Nutrition: Everyday Foods That Support Whole-Body Health
    June 15, 2025
    The Wide-Ranging Benefits of Magnesium Supplements
    June 11, 2025
    The Best Home Remedies for Migraines
    June 5, 2025
    The Hidden Impact Of Stress On Your Body’s Alignment And Balance
    May 22, 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
    turo lawyer
    Why A Good Turo Lawyer Can Help Cover Medical Fees
    April 8, 2024
    Comprehensive Healthcare Treatment for Slip and Fall Injuries: A Guide to Recovery
    Comprehensive Healthcare Treatment for Slip and Fall Injuries: A Guide to Recovery
    December 26, 2023
    Medical Negligence
    The Impact of Medical Negligence: How Claims Can Help You Move Forward
    January 6, 2025
    Latest News
    Let Your Lawyer Handle the Work Before You Pay Medical Costs
    July 6, 2025
    Top HIPAA-Compliant Messaging Apps for Healthcare Teams
    June 25, 2025
    When Healthcare Ends, the Legal Process Begins: What Families Should Know About Probate and Medical Estates
    June 20, 2025
    Preventing Contamination In Healthcare Facilities Starts With Hygiene
    June 15, 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

Healthcare and Health IT in 2015: Seeking Simplicity
Can Personal Injury Trials Complicate Your Medical Bills?
5 Public Health Crises Other Than COVID-19 That Still Exist
Health Reform’s Impact on Benefits Administration
Does Obamacare Really Depend on the Young?

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

9 Lifestyle Tweaks That Can Add Years to Your Life
9 Healthcare Lifestyle Tweaks That can Add Years to Your Life
lifestyle
July 11, 2025
car accident lawsuit
Let Your Lawyer Handle the Work Before You Pay Medical Costs
Policy & Law
July 6, 2025
women dental care
What Is a Smile Makeover and How Much Does It Cost?
Dental health
June 30, 2025
HIPAA-Compliant Messaging Apps
Top HIPAA-Compliant Messaging Apps for Healthcare Teams
Global Healthcare Policy & Law Technology
June 25, 2025

You Might also Like

IPAB: Fix It, Don’t Repeal It

August 9, 2011
eHealthGlobal HealthcareHealth careNewsSurgery

Robots Are Being Programmed To Perform Spine Surgeries

November 25, 2019
stop bleeding after an injury
News

6 Quick Steps to Stop a Bleeding Wound

March 17, 2021

How To Find Amazing Medical Market Statistics on Physician Activities and Reimbursement

June 18, 2015
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?