FDA Transparency Blog

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  One goal of EO 13563 is to target rules already on the books to increase flexibility and remove regulations that are out-of-date, unnecessary, excessively burdensome, or in conflict with other rules.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

The FDA doesn’t regulate in a vacuum. We need to listen to all our stakeholders – the American people who we protect and the industries we regulate. One important way we do this is by a process called retrospective review of regulations.

So what does this mean? As part of a process begun by President Obama, the FDA today announced that we are formally asking for submissions on how to improve existing regulations. Retrospective reviews like this really help us focus on how we can improve our regulations and give us invaluable insights on how we, and those we regulate, can be more innovative and take advantage of innovation as we work to protect and promote the public health.

For FDA, review of regulations is grounded in straightforward principles. First, regulations should change with the times. Second, they should not impede innovation and, if possible, foster it. Third, the effort they call for (the burden or cost of complying) should be reasonable. Fourth, they should not be ineffective. In other words, regulations should make sense, and if they don’t, we should change, strengthen, clarify, streamline, or revoke them.

That’s where you come in.

We want to hear from you. Help us identify areas to focus and improve. Where are our regulations ineffective? Do our regulations address current public health challenges? Where do we need to update our regulations? Can we revise them in ways that makes them less burdensome without making them less effective? Where can we be more flexible? How we can put greater emphasis on innovative scientific approaches? Do we have regulatory requirements that are redundant, inconsistent or needlessly overlap?

We’re most interested in big ideas, ones that identify regulatory problems that have the greatest impact on the public health.

If you want to help us with this important task, you can learn more by visiting the Federal eRulemaking Portal and following the instructions for submitting comments.

We are looking forward to your suggestions. Thank you very much – Leslie

Leslie Kux

Assistant Commissioner for Policy (Acting)

Today’s release of a strategic priorities document outlining the goals and strategies that the FDA and its 12,000 employees will pursue through 2015 marks a renewal of our commitment to creating a stronger, more effective agency.

Titled “Strategic Priorities 2011 – 2015: Responding to the Public Health Challenges of the 21st Century,” the 50-page document provides a vision of the FDA that includes:

• a modernized field of regulatory science that draws on innovations in science and technology to help ensure the safety and effectiveness of medical products throughout their life cycles
• an integrated global food safety system focused on prevention and improved nutrition
• expanded efforts to meet the needs of special populations.

Senior staff from the FDA’s seven product and research centers and two major offices contributed to the document. A Federal Register notice that invited public input in October 2010 generated more than 200 comments that were considered for the final document.

The field of regulatory science and innovation is among five cross-cutting areas that will serve as strategic priorities at the agency during the next five years.

The FDA must have the capacity to effectively oversee the translation of breakthrough discoveries in science into innovative, safe, and effective products and life-saving therapies. This document sets forth our priorities for achieving that goal.

Thank you,

Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs