So many people have been laser focused on the FDA's Part 15 Meeting on the use of social media to promote medical products being held this week in Washington, that the meeting on the same two-days of the Risk Communications Advisory Committee has gotten scant attention. So let's pay attention, shall we?
While the agenda appears rather unremarkable and even uninformative, the content itself has much more to say about the directions of the FDA's thinking with respect to communication – and the outcome may have more immediate impact than that of the Part 15 meeting, the contents of which is going to take the FDA months to digest, much less act upon.
Specifically, the material from the FDA Transparency Task Force is going to present hypothetical emerging public health case studies that raise specific questions about how the FDA should react to the situation.
First Hypothetical Case Study: Early Communication about Emerging Safety Issues about FDA-Regulated Products
State and local public health authorities have been investigating an outbreak due to a foodborne pathogen. There are 18 illnesses primarily in one state with a few in a neighboring state. According to the human laboratory data, the same strain of pathogen caused all of the illnesses. One individual has died. The epidemiological investigation by the states found sandwiches and salads in common but no epidemiologic study is underway yet to implicate a specific food item.
• Should FDA communicate this outbreak to the public? If so, what should the agency say? Is there anything that should not be communicated?
• Should knowledge of the specific pathogen causing the outbreak influence the agency’s decision?
• Should the population that may be potentially exposed to the pathogen affect whether, and when, a message should be communicated?
• How should FDA effectively communicate to consumers as the investigation evolves and new information changes the picture?
The answers to these questions are going to provide a great deal of insight into how the FDA is going to approach outbreaks in the future and could provide guideposts that will better inform industry (frankly – food, device and drug, even though it is a food example) of the parameters and tripwires that will be used in the future for communicating to the public.
Consider the next hypothetical as well:
Second Hypothetical Case Study: Early Communication about Emerging Safety Issues about FDA-Regulated Products
There is an outbreak of a foodborne pathogen with 50 people ill in five states, many of whom have been hospitalized. State and local epidemiologists and CDC are investigating the human illnesses.
CDC alerts FDA that the epidemiological investigation conducted shows a link to fresh fruit salad consumed at various restaurants. Although recipes varied at the restaurants, three fruits were common to all of the salads consumed. Preliminary data suggests that cantaloupe is the cause. FDA contacts industry and they provide general distribution information indicating that cantaloupe is typically distributed nationwide. FDA has initiated a traceback of cantaloupe.
Produce trade associations have asked FDA and CDC for the information the agency has gathered about the source of the outbreak. These associations tell the agency that they can assist with the investigation if the agency provides them with more information about the outbreak.
(Note: Because the purpose of the discussion is to elucidate the policy considerations that should be weighed in deciding whether changes to current practice, laws, or regulations are warranted, the issues should be discussed without regard for the current practice, laws, or regulations.)
• Should FDA advise the public about this outbreak? What are the factors that should be considered in deciding whether to do so? Is there anything that should not be communicated?
• If the agency communicates to the public about the outbreak, what message should be communicated to consumers? What geographic area should be covered?
• Should FDA communicate to members of industry whose products may be implicated in the outbreak? If so, what is the message?
• How should FDA work with industry to address the outbreak?
• Another entity, based on its own analyses, believes the outbreak is due to another fruit and releases a public statement to that effect. How should the agency respond?
This discussion will shed a lot of light as to how the FDA may work with industry in the future surrounding a problem with a product. Until now, FDA has had to be sensitive to how closely the agency works with industry out of concern that the FDA could fall victim to charges from policy-makers and consumer groups that it is playing ball with industry rather than regulating. Getting answers to the conditions of this hypothetical could give the FDA more cover for working more closely with industry to resolve outstanding issues, protect the public health and to get more hands on deck in a time of emergency.