• INDUSTRIES
  • SERVICES
  • FDA REQUIREMENTS
  • NEWS & MEDIA
  • BLOG
  • ABOUT
  • CONTACT
  • SHOP

The Administrative State and Cost Benefit Analysis: Who Really Benefits?

admin January 25, 2011 Law & Regulatory No Comments

Tags: administration, administrative, analysis, benefit, cost, FDA, government, industry, obama, regulations, usa

In an executive order signed last week, President Obama ordered all government agencies to conduct a cost-benefit analysis before issuing a new regulation and to develop any future regulations in the least-burdensome manner possible and with specific performance goals. Obama also instructed federal agencies to seek and assess all available alternatives to direct regulation before issuing a new rule.

In an opinion piece published in The Wall Street Journal, Obama singled out the FDA as an example of an agency whose regulations have caused confusion.

Cost benefit analysis must benefit the government too, you know.  Obama is not saying “Be nice to industry for a change.”  He is saying “Get done in your agencies what I cannot get done in Congress.”  Cost benefit analyses are for FDA too; least burdensome to whom?  The least-burdensome would be to reduce the burden of existing regulations — that is not proposed at all.  Specific performance goals will not be “performance goals for FDA” but “performance goals for the OUTCOME,” the burden of which will always be carried by the industry and imposed by the government.

Do the math on who benefits and who it costs.  FDA and President Obama are not looking for ways to benefit the industry — just their opinion on what policies the drug or device or food industries should advance.

Assessing all available alternatives to direct regulation means: no notice and comment, no administrative procedures— just guidance.  Why? Because it is more expensive for FDA (for instance) to issue a rule and it takes too long. FDA can issue guidance, implement it like a rule and dare you to sue them tomorrow.  This is the triumph of the Administrative State.

 

- Benjamin L. England, Founder

www.FDAImports.com

 

Google+FacebookTwitterRedditStumbleUponPinterestLinkedInShare

You can skip to the end and leave a response. Pinging is currently not allowed.

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

*

*

HTML tags are not allowed.

« Analyzing the Food Safety Modernization Act
Pharma Companies Get a Surprise: Food Safety Modernization Act »


  • Get our blog in your inbox


     



  • Topics

    • China (31)
    • Company News (73)
    • Cosmetics (30)
    • Dietary Supplements (12)
    • Drugs (17)
    • Events (16)
    • Food (101)
    • Food Safety Modernization Act (46)
    • Humor (10)
    • Imports (55)
    • Law & Regulatory (122)
    • Medical Devices (15)
    • Uncategorized (4)
    • USDA (3)
  • Archives

-->

© 2013 FDAImports.com, LLC. All Rights Reserved.
810 Landmark Drive, Suite 126  |  Glen Burnie, Maryland 21061  |  ph: (410) 220-2800  |  fx: (443) 583-1464
FDAImports.com, LLC is a private FDA regulatory consulting firm and is not the FDA

Privacy Policy  |  Disclaimer  |  Sitemap  |  Glossary  |  Choose Your Language