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
    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
    OTC Drugs Should Qualify as Medical Expense for Tax Purposes
    August 5, 2011
    ACOs
    ACOs and Patient Safety: Dos and Don’ts: Video
    May 15, 2012
    America Has A Health Care Paradox
    September 19, 2012
    Latest News
    Preventing Contamination In Healthcare Facilities Starts With Hygiene
    June 15, 2025
    Strengthening Healthcare Systems Through Clinical and Administrative Career Development
    June 13, 2025
    Building Smarter Care Teams: Aligning Roles, Structure, and Clinical Expertise
    May 18, 2025
    The Critical Role of Healthcare in Personal Injury Recovery: A Comprehensive Guide for Victims
    May 14, 2025
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: Can We Take the Excitement out of the FDA? Agency Could be Turning a Corner
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 > Can We Take the Excitement out of the FDA? Agency Could be Turning a Corner
Business

Can We Take the Excitement out of the FDA? Agency Could be Turning a Corner

Caroline Popper
Last updated: October 10, 2011 12:30 pm
Caroline Popper
Share
4 Min Read
SHARE

The U.S. Food & Drug Administration (FDA) likes to trot out the statistic that claims it regulates about $100 billion in biomedical R&D each year: investments made by industry (and government) to create new innovations to treat today’s health challenges. But the agency has been hesitant to address another facet of investments: that they should be predictable. As the late, great economist Paul Samuelson said, “Investments should be like watching paint dry. If you want excitement, take $800 and go to Las Vegas.”

The U.S. Food & Drug Administration (FDA) likes to trot out the statistic that claims it regulates about $100 billion in biomedical R&D each year: investments made by industry (and government) to create new innovations to treat today’s health challenges. But the agency has been hesitant to address another facet of investments: that they should be predictable. As the late, great economist Paul Samuelson said, “Investments should be like watching paint dry. If you want excitement, take $800 and go to Las Vegas.”

Anybody who’s watched the stock market the last few years knows we would rather live without this kind of excitement. However, the latest documents issued by the FDA – from Research Use Only/Investigational Use Only (RUO/IUO) guidance to LDT to the latest strategy document on boosting innovation (read coverage from Xconomy) – are inconsistent enough to make drug development resemble a Roulette wheel, rather than a science-based, multi-year, multibillion-dollar strategy to develop therapeutics and diagnostics. Even venture capitalists, not known for their risk-averseness, have gone to Congress to demand more predictable responses from the FDA.

Could the FDA be showing signs—finally—that it is aware it needs to change its stripes? In its recent “Driving Medical Innovation” strategy document, the agency outlines a number of steps to streamline clinical trials for critical treatments, encourage more external input in policy-making, review policies and regulations for unnecessary obstacles, and train its staff to keep up on fast-breaking innovations in biotechnology. All of these are good things—we especially like the new small business liaison program and fellowships for young entrepreneurs. And the tentative list of Entrepreneurs in Residence looks impressive.

More Read

benefits outsourcing medical billing
Benefits of Outsourcing Your Medical Claims Processing
Let a Thousand Free Markets Bloom
Lessons on Building a Great Ortho Team from The Avengers
Give Forward – a Social Solution for Out of Pocket Medical Care
A Commitment to Quality IRO Services – A Letter From Our Medical Director

Like all of us who work in life science, the FDA faces many challenges, not the least of which is keeping up on new technology. While the agency has always acknowledged its dual roles as regulator and facilitator of innovative products, it now appears to be taking some realistic steps to embrace its latter role. If the reforms result in a more predictable, faster regulatory process, while maintaining safety obligations, then biopharmaceutical companies, investors, patients, health care providers and the U.S. economy can all win. Without the gambling.

What do you think of these FDA reforms? Will recent actions help create a clearer pathway for therapeutics innovation? Is there a broader opportunity for post-market surveillance, especially in assessing diagnostics? We look forward to learning your thoughts.

TAGGED:FDA
Share This Article
Facebook Copy Link Print
Share

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

healthcare facilities
Preventing Contamination In Healthcare Facilities Starts With Hygiene
Global Healthcare Infographics
June 15, 2025
from gut to glow
From Plate to Wellness: How Everyday Foods Nourish Your Body Inside and Out
Dental health Infographics Specialties
June 15, 2025
beyond nutrition
Beyond Nutrition: Everyday Foods That Support Whole-Body Health
Health Infographics
June 15, 2025
Transcranial Magnetic Stimulation (TMS) Therapy
How TMS Therapy Helps with Treatment-Resistant Mental Illness
Mental Health Therapies
June 13, 2025

You Might also Like

hospital advertising
BusinessHospital Administration

Should Hospital Websites Be Labeled for Consumers as Advertising?  

March 20, 2015
preventable readmissions to hospitals
BusinessHospital AdministrationPublic Health

The “7 Deadly Sins” That Lead to Preventable Readmissions

September 25, 2014

No Doctors for the Elderly

April 29, 2011

How Madison Avenue’s Medical TV Ads Fall Short

April 13, 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?