FDA Plan Seeks Better Communication with Public

The FDA has released a strategic plan for communicating with the public about food and drug risks, recalls, and warnings.

The plan, released on Wednesday, will take five years to implement and is designed to make sure that the FDA is communicating risk information clearly, effectively, and in a manner which makes it easy for the general public to understand what is important for them to know.

“We are committed to improving communications the public receives about the products we regulate,” said Dr. Margaret A. Hamburg, Commissioner of Food and Drugs. “The FDA must communicate frequently and clearly about risks and benefits and inform patients and consumers about ways to minimize risk as they become increasingly involved in managing their health and well-being.”

The strategic plan seeks to use a combination of sound science, multimedia and public feedback to make communications with the public more effective and meaningful. The plan includes a list of 70 different actions the FDA will undertake to improve risk communications over the next five years. Some of those changes include:

• Posting pictures of products affected by high-priority recalls.
• Creating a multimedia library on safe food practices that can be used for general education or during food contamination crisis.
• Conducting a series of surveys to assess the public’s understanding of, and satisfaction with, FDA communications about drugs and medications.
• Create a publicly accessible, easy-to-use database of FDA risk communications.
• Use social media, such as Twitter, to help send out urgent messages to the public on health risks, food contamination outbreaks and recalls.

The FDA also wants to develop a plan that will explain to the public the likely impact of FDA’s new oversight over tobacco products.

The plan was released on the same day that the FDA released draft guidance for industry on how to submit Risk Evaluation and Mitigation Strategies (REMS). REMS are strategies developed by drug companies and approved by FDA that help ensure a drug’s benefits outweigh its risks. They are often used for drugs with high health risks that are essential to patients with certain conditions that would be difficult to treat without the drug.

The draft guidance describes in detail for the industry what should be in a REMS, when they will be required and how they should differ based on certain regulatory situations. The draft guidance also provides an example of what an approved REMS would look like.