FDA, Transparency, and Consumer Protection

Most people are aware that the FDA is a federal agency and its mission is to protect the health and safety of the American public.  What many people fail to realize is that FDA inspectors are federal agents.  FDA agents are sworn into duty, taking an oath to protect health and human safety.  Since its inception, the agency’s mission and focus has been to provide the American consumer a level of protection that they cannot provide for themselves.
The mechanisms the agency has developed in order to provide this protection are numerous.  Some of the best known are those that involve direct interaction with industry, and they include:
  • Managing clinical trials
  • Reviewing clinical data and granting companies a license to sell products or execute medical procedures
  • Enforcing manufacturing, packaging, holding, distribution and advertisement standards, by routinely inspecting facilities
  • Monitoring post market adverse events that may occur as the result of product usage
  • Monitoring and assisting industry in recalling product from the marketplace
  • Interpreting regulations and proposing draft legislation based on their experience interacting with the industry

However, FDA’s mission does not end here.  The agency has an incredible amount of visibility to the current state of the safety of the drugs and devices sold in the US.  A critical aspect of protecting any consumer, is educating that consumer.  Toward that end, FDA has developed many mechanisms designed to transfer the knowledge they have gained, to the American public.

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Even members of industry find it challenging to remain abreast of recalls, inspection findings, and enforcement actions taken against facilities that fail to meet federal requirements.  And as we all know, only the most egregious situations are featured in the national media, and even if a situation is covered by the media, it is rarely covered in any depth.
If members of industry find this a challenge, we should be able to imagine how difficult it must be for the average consumer to obtain, interpret, and use this information to protect their families.  As the FDA has an obligation not only to protect, but also to educate and inform the public, the agency’s communication mechanisms and web-site have been designed to make useful and understandable information about FDA activities and decision-making more readily available to the public, in a timely manner and in a user-friendly format.
The modern FDA is even on Face Book, Linkedin, Twitter and Flickr!
Now their only challenge is encouraging the American consumer to make use of these services!
We at Coda Corp USA feel that this information is worth highlighting.  Let’s start with the basics.
The FDA’s web site is divided primarily in two halves – one for the industry that it regulates – and the other for the consumer this regulation is meant to protect.
For consumer protection information – please visit:
The information on this page includes:
  • Information in English and en Espanol
  • Information categorized by product type (e.g., food or drug)
  • Information displayed to prominently high light current and severe safety issues, recalls and alerts
  • A service that allows users to automatically track and follow news and receive automatic notification via email
  • Information presented in multi-media formats
  • A listing of FDA contact information and primers regarding the structure and nature of the agency, including addresses and numbers to use to report adverse effects, or to ask for general assistance
  • A list of cooperative partnerships that the FDA maintains, with links to partner sites (e.g., Everyday Health, WedMD and Dugs.com)
Now, let’s take a closer look at the multi-media page:
This page provides consumers a wealth of easy to access services, in multiple formats, including, videos, podcasts, web links, slide shows and external web links.  The information presented covers a wide variety of topics, including:
Consumer Updates:
This is a portal to the highest profile safety warnings released by the agency.  This can range anywhere from recent recalls to the latest news about fad diets and products that FDA feels the public should be wary of, like smokeless cigarettes and soft drinks which combine alcohol and caffeine.  These warnings are FDA’s manner of telling us what they are currently evaluating.  This means that they have not taken action yet, but they are studying effects of products in order to determine the need to take action.  This section will also provide timely general health tips  such as prepping for protection against common winter illnesses.
FDA Patient Safety News:
This is a televised series designed for health care workers, featuring information on new drugs, biologics and medical devices, FDA safety notifications and product recalls, and on ways to protect patients when using common medical products.
This section showcases FDA’s efforts to communicate directly to the public via professionally engineered videos, meant to inform, and educate.  The video library has been designed to consumer minimal broadband, making them available to all types of user environments.  The library covers a wide variety of topics, providing tips on everything from woman’s health, vitamins, allergy management, x-ray exposure, indoor tanning and FDA tutorials.
This section is designed to draw attention to topics of recent interest which are highlighted here due to their current nature.  The contents of the spotlight vary daily and the contents of this section will eventually be located within other sections of the page – you might refer to this as “today’s news.”
Recalls & Alerts:
This section provides a listing of recent recalls or alerts presented as summaries, supplemented with links to new releases that contain detailed information.
Photo Slide Shows:
This section presents links to various photo slide shows that have been produced to help raise awareness of FDA initiatives, actions and often times to provide the public a view of the FDA in the field.  These presentations help us to see the many faces of FDA, and to help the public become more familiar with the scope of services provided by the agency.
These podcasts provide audio recordings regarding drug safety information, to be used in conjunction with the release of Public Health Advisories.  Podcasts can be downloaded, imported to external websites, or streamed from the FDA web site for those that may have not time to read the associated articles.
The FDA in order to achieve its mission of protecting the health and safety of the American public, has modernized its website in order to make available, in every format possible, consumer driven information that will help us to protect ourselves and our families.  We at Coda Corp USA would like to encourage all of our blog followers to visit the web page regularly.  Take advantage of the information that your tax dollars have paid to have this information collected and distributed, and take an active role in keeping yourselves and your families healthy and safe.
Remember: The best consumer is the educated consumer!
Stay safe, and have a Happy Thanksgiving!
© Coda Corp USA 2010.  All rights reserved.
Gina Guido-Redden and Corrine R. Knight
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