Upcoming Event: FDA Basics Webinar on Foreign Inspections, May 17, 2011, at 12:30pm ET

May 12, 2011 27 comments

Did you know that FDA foreign inspections have doubled since 2008? Did you know that foreign food inspections alone have quadrupled since 2010?

As part of FDA Basics, FDA is hosting a webinar on foreign inspections where you can learn more. Susan Laska, the Deputy Director of the Division of Foreign Field Investigations, will give an overview and answer questions about FDA’s Global Inspection program.

The free 30 minute webinar will be held Tuesday May 17, 2011 at 12:30 pm 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

What needs fixing and how can we fix it?

April 26, 2011 62 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: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm249437.htm
and a link to the search Web page: http://www.fda.gov/Safety/Recalls/default.htm.

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FDA Continues to Issue Warning Letters for Illegal Tobacco Sales to Minors

March 29, 2011 19 comments

Every day nearly 4,000 kids under 18 try their first cigarette and 1,000 kids under 18 become daily smokers. Virtually all new users of tobacco products are under the minimum legal age to purchase such products. Many of these kids will become addicted before they are old enough to understand the risks and will ultimately die too young of tobacco-related diseases.

FDA is working to protect the health of America’s children and ultimately reduce the burden of illness and death caused by tobacco use by enforcing the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) and Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents. This regulation, which took effect on June 22, 2010, limits the sale, distribution, and marketing of cigarettes and smokeless tobacco to protect the health of children and adolescents.

FDA works to inform retailers about these laws through the Break the Chain of Tobacco Addition campaign. FDA will also host a series of Compliance Training for Tobacco Retailers, to be held on March 29, April 26, May 18, June 28, July 26, and September 20, 2011, to provide retailers with training on federal tobacco regulations.

Last year, in order to help enforce these laws, FDA awarded contracts to 15 states to assist in inspecting retail establishments that sell cigarettes and/or smokeless tobacco products. In the upcoming years, FDA plans to award enforcement contracts to all states and U.S. territories to assist with enforcement of the Tobacco Control Act.

The goal of the State Enforcement Program is to improve public health and to protect young people by bringing enforcement action against retailers who violate the law. State inspectors under these FDA enforcement contracts conduct compliance check inspections to determine if retailers comply with the law, including whether the retailer:

  • sells a tobacco product to a minor;
  • requests proper identification;
  • sells prohibited flavored cigarettes or individual cigarettes; and
  • sells tobacco products in a self-service display, like a vending machine, which can be accessed by minors.

We appreciate the efforts and commitment of all states who have contracted with FDA to assist in enforcing the Tobacco Control Act and FDA regulation. More than 95 Warning Letters have been issued to retailers for illegal sales of cigarettes and/or smokeless tobacco to minors. FDA’s website posts Warning Letters that have been issued as well as a list of retailers that have been inspected and where no violations were observed.

We encourage anyone who is aware of retailers who may violate the Tobacco Control Act to report violations to FDA’s Center for Tobacco Products through our website, by email or by phone (1-877-CTP-1373).

Thank you,
Ann Simoneau
Director, Office of Compliance and Enforcement

New Spanish-Language Website Increases Access to FDA Tobacco Information

March 10, 2011 52 comments

I am pleased to announce that many portions of FDA’s Center for Tobacco Products (CTP) website are now available in Spanish. This new resource for the Spanish-speaking community will provide key information to our stakeholders in our common goal of reducing the tremendous toll of illness and death from tobacco use through FDA’s new role in tobacco product regulation. By increasing access to our content to the Spanish-speaking public we not only increase the reach of our message, but also make further in-roads into communities that play a key role in tackling this important public health issue.

Over the last several months, I’ve heard from many stakeholders in a number of ways about the overall need for CTP to provide key tobacco product information in different languages. This was echoed by a request from a woman named Sarah who submitted a request for low-literacy handouts in multiple languages to our CTP Tobacco Ideas Forum (which is a novel way for the public to submit a thought and then have it voted on by other stakeholders). Input like this from the general public, combined with what we’ve learned through many other communication channels, has led to the launch of this Spanish-version website. The first of several plain language handouts similar to what Sarah, and many others have requested, as well as a variety of free resources and tools are now available. These include:

  • The Break the Chain of Tobacco Addiction retailer education campaign web area, which includes translated printed materials that can be ordered online;
  • An digital timeline of the Tobacco Control Act, which highlights past achievements and upcoming deadlines required by the Act;
  • Multiple ways to connect with the us through social media;
  • Federal resources on youth tobacco prevention, effective treatment for nicotine addiction, and tobacco research and statistics;
  • And much more!

I encourage you to check out www.fda.gov/tabaco and let us know what you think. I also hope you will contribute to the CTP Tobacco Ideas Forum. We are listening and want your ideas to improve our efforts to effectively disseminate information about FDA tobacco regulations and to develop innovative ways to educate the public about the dangers of tobacco products use.

Thank you

–Lawrence R. Deyton, M.S.P.H., M.D., Director, FDA Center for Tobacco Products


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