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
    health coach
    Health Accountability Coach: Your Partner for Lasting Wellness
    July 25, 2024
    How Dr. Brian Richardson Diagnoses Urinary Tract Disorders
    Understanding Urodynamic Testing: How Dr. Brian Richardson Diagnoses Urinary Tract Disorders
    December 2, 2024
    medication suppliers
    Choosing the Right Supplement Manufacturer for Your Brand
    May 1, 2025
    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
    A New Call-to-Action: Strong Is the New Skinny!
    January 23, 2013
    Raise Medicare Age? That’s Cost Shifting, Not Cost Saving
    February 28, 2012
    Image
    Low Teen Birth Rates and Universal Health Care
    April 3, 2013
    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: A Von Eschenbach Sighting
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 > A Von Eschenbach Sighting
BusinessPolicy & Law

A Von Eschenbach Sighting

gooznews
gooznews
Share
3 Min Read
SHARE

Former Food and Drug Administration commissioner Andrew Von Eschenbach, who ran the agency from 2005 to 2009 and has now decamped to the conservative Manhattan Institute, had this advice for reforming the agency in this morning’s Wall Street Journal:

(Reform) means creating FDA pilot programs to bring promising therapies to patients more quickly by allowing them to be approved based on safety, with efficacy to be proven in later trials.

Former Food and Drug Administration commissioner Andrew Von Eschenbach, who ran the agency from 2005 to 2009 and has now decamped to the conservative Manhattan Institute, had this advice for reforming the agency in this morning’s Wall Street Journal:

(Reform) means creating FDA pilot programs to bring promising therapies to patients more quickly by allowing them to be approved based on safety, with efficacy to be proven in later trials.

Right. Give a drug industry that already fails to complete two-thirds of its mandated post-marketing trials a blank check to dump hundreds of unproven molecules on the market so that insurers, including Medicare, will have to pay for them. I’m surprised he didn’t also call for balancing the budget.

Now, to be fair, he also said that “the product could be approved for marketing with every eligible patient entered in a registry so the company and the FDA can establish efficacy through post-market studies.” In essence, he’s saying let’s abandon the gold-standard of double-blind, placebo-controlled clinical trials for determining efficacy, and substitute post-hoc epidemiological studies based on registry data.

I’m a big fan of registries. I believe their data can be used to determine efficacy. I look forward to the day when there are registries up and running for all the borderline drugs and devices that are already on the market; registries with the scope and controls that independent scientists agree are adequate for reaching conclusions about efficacy in a post-marketing setting. On that day, we can talk about extending such registries on a pilot basis to some experimental medicines that have passed their Phase I safety trials.

TAGGED:FDAhealth reform
Share This Article
Facebook Copy Link Print
Share

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

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
recovering from injury
Rebuilding After Injury: Path to Physical and Emotional Recovery
News
June 22, 2025

You Might also Like

health reform and employment
BusinessFinanceHealth ReformPolicy & LawPublic Health

ObamaCare and Jobs

February 13, 2014

Employers as Doctors

July 9, 2011

Imaging Startup Developing Cheaper, Simpler PET Scanning in Preclinical Research

November 12, 2013
patient engagement
BusinessHospital Administration

Reducing Medical Errors with Engaged Patients and Culture Change

September 29, 2013
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?