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
    An Expert’s Guide To Building and Improving Endurance
    June 30, 2022
    medical assistants
    What Do Medical Assistants Do On a Day to Day Basis?
    April 5, 2022
    superfoods to help with prostate health
    10 Healthy Foods That Can Help Protect Your Prostate
    August 29, 2022
    Latest News
    5 Steps to a Promising Career as a Healthcare Administrator
    August 3, 2025
    Why Custom Telemedicine Apps Outperform Off‑the‑Shelf Solutions
    July 20, 2025
    How Probate Planning Shapes the Future of Your Estate and Family Care
    July 17, 2025
    Beyond Nutrition: Everyday Foods That Support Whole-Body Health
    June 15, 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
    healthcare cost crisis
    What If the Health Care Cost Crisis Solves Itself?
    May 11, 2013
    Do You Need Life Insurance? What Does It Cover?
    December 23, 2022
    HIE metal plans
    The Four “Metal Plans” of Health Insurance Exchanges
    May 28, 2013
    Latest News
    How IT and Marketing Teams Can Collaborate to Protect Patient Trust
    July 17, 2025
    How Health Choices and Legal Actions Intersect After an Injury
    July 17, 2025
    How communities and healthcare providers can address slip and fall injuries with legal awareness
    July 17, 2025
    Let Your Lawyer Handle the Work Before You Pay Medical Costs
    July 6, 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
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

An Online Market for Medical Care
Why Hospitals Need to Think Globally
5 Ways LinkedIn Helps Physicians in Marketing Their Practice
Medicare Is Lousy Insurance
Boosting Efficiency in Hospital Labs with Analytical Tools

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

technology in medical research
The Tools Helping Medical Researchers See the Full Picture
News Technology
August 3, 2025
5 Steps to a Promising Career as a Healthcare Administrator
5 Steps to a Promising Career as a Healthcare Administrator
Health
July 31, 2025
holistic dental
Holistic Dentist Services Are Natural and Safe
Dental health Specialties
July 28, 2025
botox certification
Help Improve People’s Skin Health Via Botox Certification
Skin Specialties
July 22, 2025

You Might also Like

Medical Device Tax Costs 1,000 Jobs

December 1, 2011
healthcare marketing tips
Wellness

How to Attract More Clients to your Wellness Business

November 15, 2022

Response to Austin Frakt

March 25, 2011

Janssen Labs Expands Its Incubator Model to New San Francisco Digs

May 27, 2014
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?