Home > Transparency Posts > Update on Retrospective Review of FDA Regulations

Update on Retrospective Review of FDA Regulations

Earlier this year, President Obama issued Executive Order (EO) 13563 and outlined his plan to create a 21st-century regulatory system that is simpler and smarter and that protects the health and safety of the American people in a pragmatic and cost-effective way.  One goal of EO 13563 is to target rules already on the books to increase flexibility and remove regulations that are out-of-date, unnecessary, excessively burdensome, or in conflict with other rules.

On May 26, in support of EO 13563, more than two dozen Federal agencies released plans that identified initiatives with the potential to eliminate tens of millions of hours in reporting burdens, and billions of dollars in regulatory costs.  FDA, as part of the Department of Health and Human Services (HHS), is included in the HHS Preliminary Plan for Retrospective Review of Existing Rules (HHS Plan), which can be seen at http://www.hhs.gov/open/recordsandreports/execorders/13563/draft/index.html.  The HHS Plan identifies regulations already being modified or streamlined and identifies additional candidates for further review.

The HHS Plan highlights the activities FDA is undertaking in support of EO 13563.  For example, we are reviewing the “Bar Code Rule” to assess the costs and benefits associated with it and to determine if the rule should be modified to take into account changes in technology that have occurred since the rule went into effect.  The Bar Code Rule requires certain human drug and biological products to have a linear bar code on the label so health care professionals can use bar code scanning equipment to verify that the right drug (in the right dose and right route of administration) is being given to the right patient at the right time.  Stay tuned for a solicitation of information on the Bar Code Rule. For further information about other FDA activities in support of EO 13563 see http://www.fda.gov/AboutFDA/Transparency/TransparencyInitiative/ucm257692.htm

As we go forward, we are very interested your input.  As I wrote in our April 26 blog, at http://fdatransparencyblog.fda.gov/2011/04/26/what-needs-fixing-and-how-can-we-fix-it/, we do not operate in a vacuum and we value the input of all our stakeholders.   On April 27, 2011, we published a notice in the Federal Register requesting comment and supporting data on which, if any, of our existing rules are outmoded, ineffective, insufficient or excessively burdensome and thus be candidates for review.  Please review our Federal Register notice and the HHS plan and submit your comments to FDA by June 27, 2011 at http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0259-0001.  You can also submit comment on the HHS plan at http://www.hhs.gov/open/recordsandreports/execorders/13563/draft/index.html

Thank you,

Leslie

Leslie Kux, Assistant Commissioner for Policy (Acting)

  1. June 6, 2011 at 12:11 am

    In this rapidly changing world I think a review of policies and rules is an excellent idea. Additionally, asking for and integrating outside comments is a good way to discover new ideas and problems that need to be resolved. I think what you are doing is a good first step and I hope it leads to meaningful change.

  2. June 8, 2011 at 12:30 pm

    Thank u for posting.

  3. June 8, 2011 at 5:44 pm

    Most definetly our “old way” of doing things should be reviewed and purged. I agree with Bill that “integrating outside comments” will lead to quite possibly some excellent feedback. Just by using social media as outlets of information is one step that not only the FDA can use but all federal, state and local governments as well.

  4. June 10, 2011 at 5:29 pm

    I think the time will show us that this decision was right.

  5. June 17, 2011 at 3:14 pm

    This is a great step forward. Lot of work involved to put everything on track and we will see how things goes.

    Thanks for posting this information

  6. June 21, 2011 at 3:12 am

    Very useful article that i ever read . Thanks for sharing.

  7. June 25, 2011 at 8:22 pm

    This is very good to know thanks!

  8. June 29, 2011 at 3:16 pm

    I agree with President Obama’s policy about FDA regulations. It seems fair enough. It’s good to remove all the outdated rules and regulations. This way, the service of the FDA will be faster and more efficient. Cutting the bureaucracy means better service to the masses.

  9. internetten para kazanmak
    June 30, 2011 at 3:56 pm

    Thanks for articlae,I hope so,this topic’ll educator of they,if people read this

  10. July 1, 2011 at 8:03 pm

    This was a great read. It’s good to know that despite hard times constant renovations are being done to ensure the best for our future!

  11. July 6, 2011 at 11:04 am

    I am agree with President Obama’s health policy . In this century we have to think new and should be removed out-dated rules regulations to meet our goal.

  12. 着うた 検索 ダウンロード
    July 7, 2011 at 11:10 am

    mmmm…..
    It’s Nice Article.
    I agree with President Obama’s policy about FDA regulations,too.

  13. July 9, 2011 at 4:19 pm

    This is very good to know thanks!

  14. July 10, 2011 at 2:21 pm

    Surely almost everything is changing very fast nowdays especially regulations, thanks for update!

  15. July 15, 2011 at 8:29 pm

    It’s a great news, thanks OBAMA , yes we can.

  16. August 11, 2011 at 8:08 am

    I agree with President Obama’s policy about FDA regulations. It seems fair enough. It’s good to remove all the outdated rules and regulations. This way, the service of the FDA will be faster and more efficient. Cutting the bureaucracy means better service to the masses.

  17. GxP Perspectives
    August 31, 2011 at 12:48 am

    Well, I didn’t make your deadline. I visit the FDA website several times a week but this is the first I have heard of this. You have a big website. I was very surprised to see that you didn’t even consider updating your clinical trial regulations. Part 312 last received a major revision in 1987 (or thereabouts) and there have actually been quite a few developments in the past 24 years, such as eCRFs, site management organizations, and the rise of virtual sponsors. Maybe in your next round of reviews you could consider clinical research.

  18. September 10, 2011 at 6:55 am

    Thanks for sharing.good articles.

  19. September 16, 2011 at 9:31 pm

    I think that we really need to work on simplifying our regulatory system, as well as making it more effective. I really hope that this is attainable.

  20. omegle
    September 29, 2011 at 8:57 am

    Thanks for sharing.good articles. thks

  21. internette para kazanmanın yolları
    February 19, 2012 at 12:01 pm

    This was a great read. It’s good to know that despite hard times constant renovations are being done to ensure the best for our future!Thanks for articlae

  22. internette para kazanmanın yolları
    February 19, 2012 at 12:13 pm

    I think the time will show us that this decision was right.Thank u for posting.

  23. RIgo Mijangos
    April 19, 2012 at 9:15 pm

    I have been visiting your website lately because I am interested in reading the quality articles that you post. Keep it up!

  24. Seo Danışmanı
    July 29, 2012 at 6:45 pm

    Thanks for articlae,I hope so,this topic’ll educator of they,if people read this

  25. Gelinlik
    August 17, 2012 at 3:35 pm

    It is a great weblog.
    I agree with President Obama’s health policy . We have to carefuly think new and should remove out-dated rules and regulations to meet our goal.

  26. Alternatif Kazanclar
    November 22, 2012 at 9:33 pm

    Very useful article and a great weblog
    Thanks for sharing

  27. susan sharrow
    November 25, 2012 at 4:31 pm

    i was interested in numerous subjects i found on your site? especially the security aspect..
    great work
    thank you

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