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
    medicine cabinet
    The Effect Of Finished Dosage Form Manufacturing In New Drugs
    July 5, 2022
    Improved Digestion
    Five tips to boost digestion and metabolism
    November 4, 2022
    health insurance for young adults
    Benefits of Buying Health Insurance for Your Adults
    January 12, 2023
    Latest News
    7 Most Common Healthcare Accreditation Programs: Which Should You Use?
    August 20, 2025
    Hospital Pest Control and the Fight Against Superbugs
    August 20, 2025
    Hygiene Beyond The Clinic: Attention To Overlooked Non-Clinical Spaces
    August 13, 2025
    5 Steps to a Promising Career as a Healthcare Administrator
    August 3, 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
    CMS Reports on Provider Performance
    June 7, 2011
    Sweet!! The Secret Branding of Sugar Substitutes
    February 22, 2012
    Everything We Are Doing in Health Policy May Be Completely Wrong
    July 26, 2011
    Latest News
    How Social Security Disability Shapes Access to Care and Everyday Health
    August 22, 2025
    How a DUI Lawyer Can Help When Your Future Health Feels Uncertain
    August 22, 2025
    How One Fall Can Lead to a Long Road of Medical Complications
    August 22, 2025
    How IT and Marketing Teams Can Collaborate to Protect Patient Trust
    July 17, 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

part time doctor couple
Part Time Doctor – Physician Schedule Flexibility and the “New Normal”
Why Do Some States Spend More on Health Care?
Multi-Screen Marketing: 17 Things You Need to Know
Physician Practices Revisit Telehealth to Monetize Time and Differentiate
Transparent Health Market Data Helps Patients Save Money on Healthcare

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

engineer fitting prosthetic arm
How Social Security Disability Shapes Access to Care and Everyday Health
Health care
August 20, 2025
a woman explaining the document
How a DUI Lawyer Can Help When Your Future Health Feels Uncertain
Public Health
August 20, 2025
physiotherapist at work
How One Fall Can Lead to a Long Road of Medical Complications
Health care
August 20, 2025
Common Healthcare Accreditation Programs
7 Most Common Healthcare Accreditation Programs: Which Should You Use?
Health News
August 20, 2025

You Might also Like

The HMO in Your Future

February 28, 2011
Cost transparency
BusinessFinanceHealth ReformHospital Administration

New ACA Provision Calls for Cost Transparency in Hospitals

May 3, 2014
Global Healthcare

My Big Blue Test

November 14, 2011

U.S. Pharma Industry Evolution

February 10, 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?