New Regulatory Tools Requested to Study Messaging of Regulators, Industry

| 07 January 2013 | By Alexander Gaffney, RAC, 

How does a regulatory agency best communicate and regulate essential messaging to stakeholders on a continual basis without being ignored? The US Food and Drug Administration (FDA) isn't necessarily sure, either, and is looking to the private sector for answers.

Writing on the Federal Business Opportunities website on 4 January 2013, FDA released an addendum to an earlier contact solicitation in which it sought the expertise of an outside firm to assist it in advancing "regulatory science and innovation."

In particular, FDA said it was looking for proposals that would help it accomplish any one of seven tasks:

1. Modernize toxicology to enhance product safety
2. Stimulate innovation in clinical evaluations and personalized medicine to improve product development and patient outcomes
3. Support new approaches to improve product manufacturing and quality
4. Ensure FDA readiness to evaluate innovative emerging technologies
5. Harness diverse data through information sciences to improve health outcomes
6. Implement a new prevention-focused food safety system to protect public health
7. Facilitate development of medical countermeasures to protect against threats to US and global health and security

In its 4 January addendum, FDA adds an eighth category to the notice:  Strengthening social and behavioral science at FDA by enhancing audience understanding.

"FDA seeks to identify and improve science-based approaches, including rapidly evolving communications technologies, to clear and effective communications on the appropriate uses of regulated products in order to promote health and reduce harms through informed decision making by consumers and health care professionals," the agency wrote in the solicitation.

FDA said it wants to study new methods to communicate with its stakeholders, balancing urgency, frequency, attention and action. FDA has frequently brought up the topic of communication barriers as a source of frustration, noting that even urgent recall notices can often times be ignored by healthcare providers.

For now, the notice implies that it wants to focus more on the content of the messages than on the messages' medium, with an emphasis on "different formats and amounts of numerical information in FDA communications."

FDA's notice also indicates that it is concerned that a general lack of understanding about regulatory terminology could be affecting the public's and healthcare provider's understanding of its notices. Terms, such as "safe and effective," "GRAS/GRASE" or "voluntary recall" might not mean the same thing to all people-or anything, depending on the term. A similar analysis might apply to longer statements FDA commonly requires for supplemental products ("These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease"). Such statements are intended to indicate that a product is not approved by FDA, though it may be legally marketed as a food item for non-specific health claims.

But FDA wants to study the public's comprehension of more than just its messaging; it also wants to gauge the effectiveness of messaging promoted by industry as well. Its solicitation calls for the respondent to "develop tools" to assess industry messaging (advertising, recall notices, safety warnings, etc), though it does not elaborate on its explicit intent or whether it could eventually become part of a postmarketing surveillance paradigm.

For any entity wishing to participate in the solicitation, FDA will be accepting bids until 22 May 2013 (11:59 PM EST).