Archive for April, 2011

What needs fixing and how can we fix it?

April 26, 2011 63 comments

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)

FDA ‘Strategic Priorities 2011 – 2015’

April 20, 2011 82 comments

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

Upcoming Event: FDA Basics Webinar by the Center for Drug Research and Evaluation on the Bad Ads Program, April 28, 2011, at 12 Noon ET

April 15, 2011 12 comments

Did you know that healthcare providers can play an important role in ensuring that prescription drug advertising and promotion is truthful by recognizing and reporting misleading ads?

As part of FDA Basics, FDA is hosting a webinar where you can learn more. Catherine Gray, Pharm.D., in the Division of Drug Marketing, Advertising, and Communication (DDMAC) in FDA’s Center for Drug Research and Evaluation will present an overview of the FDA’s “Bad Ad” program, specifically focusing on how to identify misleading prescription drug promotion and report this activity to the agency.

The free 30 minute webinar will be held Thursday, April 28 at 12 noon ET.

There are a limited number of spots available for the webinar. Materials from the webinar will also be made available on the FDA website following the presentation.

Learn more about the webinar, including instructions about how to join the webinar.


Ann Witt, Transparency Initiative Coordinator

FDA launches consumer-friendly Web search for recalled products

April 5, 2011 42 comments

On April 4, 2011, FDA launched a new Web search to make it easier for consumers to search for food and other product recalls. The search results are in the form of a table that organizes information on recalls since 2009, by date, product name, product description, reason for recall, and recalling firm. The table also provides a link to the news release for each recall. This new display of recall information differs from the old display, which provided links in a scroll-down format. Before launching the new search function, FDA consulted with a range of interested stakeholders on how to communicate recall information most effectively. FDA believes the new display of search results will be much easier for consumers to use. Here is a link to the news release announcing the new Web search:
and a link to the search Web page:

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