• Listen Live NOW!
  • On Demand
  • Ways to Listen
  • All Shows
    • Radio Shows
      • 1st Talk Compliance
      • FINN Voices
      • Harlow on Healthcare
      • Healthcare De Jure
      • Healthcare IT Today
      • Healthcare Upside/Down
      • Health UnaBASHEd
      • Payment Matters
      • PopHealth Week
      • The Incrementalist
      • The Scope with Dr. K
      • The Tate Chronicles
      • The Virtual Shift
      • This Just In Radio Show
      • Trending NOW
      • Value-Based Care Insights
    • Podcast Shows
      • 4sight Health Roundup
      • Ambulatory Healthcare Today
      • AMCP Podcast Series – Listen Up
      • Ask the Educator
      • Beyond the Needle
      • Conversations on Health Care
      • Healthcare Rap
      • Healthcare Mixtape
      • HealthLaw HotSpot
      • Hello Healthcare Podcast
      • The Brain Trust
      • The Digital Patient
      • The Handoff
    • Monthly Podcast Shows
      • Follow the Medical Record
      • Life-Centered Health Care
      • Paving the Path
      • Tell Me Where IT Hurts
      • The Dish on Health IT
      • The Healthusiasm Podcast
      • Trauma-Informed Life
      • Voices of Change
      • Voices of Self Funding
      • What Consumers Want
      • What’s My Tagline
  • Playlists
  • NursesNOW
    • Nursing News
      • Organizations
      • Podcasts
  • Conferences
  • Request Media Kit
  • Contact Us
Event Calendar
HealthcareNOWradio.comHealthcareNOWradio.com
  • Listen Live NOW!
  • On Demand
  • Ways to Listen
  • All Shows
    • Radio Shows
      • 1st Talk Compliance
      • FINN Voices
      • Harlow on Healthcare
      • Healthcare De Jure
      • Healthcare IT Today
      • Healthcare Upside/Down
      • Health UnaBASHEd
      • Payment Matters
      • PopHealth Week
      • The Incrementalist
      • The Scope with Dr. K
      • The Tate Chronicles
      • The Virtual Shift
      • This Just In Radio Show
      • Trending NOW
      • Value-Based Care Insights
    • Podcast Shows
      • 4sight Health Roundup
      • Ambulatory Healthcare Today
      • AMCP Podcast Series – Listen Up
      • Ask the Educator
      • Beyond the Needle
      • Conversations on Health Care
      • Healthcare Rap
      • Healthcare Mixtape
      • HealthLaw HotSpot
      • Hello Healthcare Podcast
      • The Brain Trust
      • The Digital Patient
      • The Handoff
    • Monthly Podcast Shows
      • Follow the Medical Record
      • Life-Centered Health Care
      • Paving the Path
      • Tell Me Where IT Hurts
      • The Dish on Health IT
      • The Healthusiasm Podcast
      • Trauma-Informed Life
      • Voices of Change
      • Voices of Self Funding
      • What Consumers Want
      • What’s My Tagline
  • Playlists
  • NursesNOW
    • Nursing News
      • Organizations
      • Podcasts
  • Conferences
  • Request Media Kit
  • Contact Us

A Pioneer in Public Health and Protection of Patients

Frances Oldham Kelsey, PhD, MD

Sep 1, 2015 | Posted by Industry Expert | HIT Feed, News |

Frances KelseyBy Stephen M. Ostroff, M.D., Acting Commissioner of the Food and Drug Administration

Recently our nation lost a true pioneer in public health and consumer protection.

Frances Oldham Kelsey, Ph.D., M.D., who joined FDA in 1960 as a medical officer, was known worldwide as a leader in drug safety and the protection of patients. She established that reputation in one of first FDA assignments: reviewing the marketing application for a drug called thalidomide, which was already available in dozens of countries around the world.

Despite constant pressure from the company, Dr. Kelsey refused to approve thalidomide because of inadequate evidence about its safety. As a result of Dr. Kelsey’s expertise, diligence, and integrity, the drug was never approved in the United States and Americans were largely spared the tragic birth defects and deaths experienced by patients in those countries where thalidomide was available.

This “near miss” spurred Congress and the White House to revive pending proposals to revitalize the oversight and regulation of pharmaceutical products. In the wake of the thalidomide episode, the Kefauver-Harris Drug Amendments became law in 1962. That law mandates “substantial evidence” of a drug’s effectiveness (in addition to evidence of safety that was previously required) and today continues to provide this road map for how unapproved pharmaceutical products are tested in humans.

It is fair to state that these amendments, as implemented by FDA, ushered in the modern era of science-based proof that the medicines we use are both safe and effective, a level of evidence that created a standard still in effect today.

Dr. Kelsey’s original work on the thalidomide application stands today as a legendary example of how FDA carries out its public health mission: judicious exercise of authority and oversight to protect consumers and patients.

Dr. Kelsey joined FDA during a different era and was a trailblazer in many ways, including the role of women in science. And yet, although this is a new era, our mission endures: to promote innovation while protecting the health and welfare of Americans. And FDA continues to be defined by the same rigor, dedication, and integrity that informed Dr. Kelsey’s work.

Our nation owes a great debt of gratitude to Dr. Frances Oldham Kelsey for her decades of service to public health.

This article was originally published on FDA Voice and is reprinted here with permission.

Share on twitter
Twitter
Share on linkedin
Linkedin
Share on facebook
Facebook
Share on pinterest
Pinterest
Share on reddit
Reddit
Share on email
Email
Share this...
Tags: FDA VoicesFrances Oldham Kelsey PhD MDStephen M. Ostroff MD

Radio for the Healthcare Industry

No HTML5 audio playback capabilities for this browser. Use Chrome Browser!

Categories

Get our News Digest

Get Our News Digest


Thank you!

You have successfully joined our subscriber list.

.

Follow Us on Twitter

My Tweets

About HealthcareNOWRadio.com

HealthcareNOWradio.com is an Internet radio station operated and produced as part of Answers Media Network. The station offers interviews, and commentary from industry leaders in healthcare and health information technology, as well as originally produced programming hosted by industry leaders. Listen on any device 24/7. You can also subscribe to get notification when a new show airs.

Sign Up for Our e-News Digest

Get notified when a new show airs or when your favorites are available as podcasts. Sign up here

Our News Media Site

Connect with Us

Contact Us

Contact a Host

Media Kit

Listening Guide

 

Follow Us

Our Radio Hosts on Twitter

Tweets by @HCNowRadio

©2023 Answers Media Company, LLC

  • Healthcare NOW Radio Media Kit
  • Contact Us
  • Our Privacy Policy
  • Our Guests and Recording Policy
Prev Next