Archive for June, 2011

Update on Retrospective Review of FDA Regulations

June 3, 2011 28 comments

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  One goal of EO 13563 is to target rules already on the books to increase flexibility and remove regulations that are out-of-date, unnecessary, excessively burdensome, or in conflict with other rules.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  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

As we go forward, we are very interested your input.  As I wrote in our April 26 blog, at, 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!documentDetail;D=FDA-2011-N-0259-0001.  You can also submit comment on the HHS plan at

Thank you,


Leslie Kux, Assistant Commissioner for Policy (Acting)

%d bloggers like this: