FDA Risk Communication Advisory Committee – Public Forum to Discuss Strategic Plan for Risk Communication and Health Literacy
Thank you for this opportunity to speak today. My name is Samantha Watters and I’m Director of Communications and Outreach for the National Center for Health Research. Our Center conducts and scrutinizes medical research to determine what is known and not known about specific treatment and prevention strategies. We do not accept funding from companies that make medical products, so we can be unbiased while focusing on patient-centered and public health perspectives.
We then translate that complicated information into plain language so that patients, consumers, media, and policy makers will understand it.
My background is an unusual one with degrees in Biochemistry, English, and Public Health with a focus in Health Communication. I’ve also written health communication materials at the NIH. I am well aware that great scientists don’t necessarily know how to communicate that science to the public. That is our Center’s challenge, as well as the FDA’s challenge.
After reviewing the draft Strategic Plan and numerous current FDA documents, we have several suggestions.
- FDA needs more staff who are extensively trained in plain language communication –going beyond the standard computer-based training course that everyone has to take and no one reads. FDA materials do not seem to reflect best practices in health communications. I don’t know why that is, but there is a lot of room for improvement. I will say that the FDA’s Office of Women’s Health seems to do a better job of communicating to patients, and other staff at FDA could possibly learn from them and from colleagues at the NIH.
- You mention consistency in branding, formatting, and communications coming from FDA, with an understanding of all your potential communication channels. This is good, but while consistency is important, part of tailoring your message to your target audience means varying format, as well as method of dissemination. Many of your current educational materials are not easy to find online or readily accessible, and those that are easy to find are not always easy to read. A lot of people don’t like to read at all, or don’t read well. That’s why it is important to communicate risk information at the 5th grade or 8th grade level. The FDA has not been doing that.
- FDA communications to patients need more graphics and fewer words. Just adding a graphic doesn’t necessarily help if it is still full of words, too busy or confusing, or not colorful or engaging. This is also going to change based on the age of your audience, since the size and color of a font, both on paper and on a screen, is crucial for the aging population. There is also a tendency to include a lot of information because, of course, there is so much to know. However, the more focused your piece can be, the better. The more complicated it is, the less likely someone will be to read it at all, let alone to retain what they’ve read.
- A major problem for FDA communication is how it has become increasingly promotional, rather than providing objective information about the products that the FDA regulates. Academic researchers have been studying FDA press releases and other materials, and concluded that FDA press releases often are used for promotional purposes and that doctors and patients misunderstand the content. The underlying message for many FDA press releases is that the FDA has done something wonderful by approving this new product, and the company has done something wonderful by making it. Information about risks or restrictions are downplayed. For example, when the FDA approves a drug through the “breakthrough” pathway, the use of the term “breakthrough” in the press release makes the media and the public think this is the best drug available. The FDA does not adequately convey all the unknowns about breakthrough drugs, which are often approved based on smaller, shorter term studies of surrogate endpoints, rather than clinically relevant benefits, such as living longer or spending fewer days in the hospital.
Sadly, when drugs or devices are found to have life-threatening side effects, the FDA is not likely to send out a press release to warn doctors or patients in a way that gets their attention. For example, if a product has a brand name, it should be prominently used in those warnings so that patients will know what you are talking about. An example of this would be Infuse bone cement. It is approved for use in adults 18 and older, but contraindicated for children. When it was used in spinal surgery with children, several experienced cranial swelling so severe that their faces became terribly engorged, requiring additional surgery. Here are photos of 2 toddlers. And in the next 2 slides are the language that FDA provided years later, to finally warn doctors and patients. You can see how inadequate that warning is. Effectively conveying the actual severity of the risk can help prevent tragic off label uses like this.
- Similarly, FDA needs to do a better job of preventing misleading information and inadequate explanations of risk in direct-to-consumer ads. Requiring companies to list risks doesn’t necessarily tell patients what they need to know, since most patients will not have the health literacy to understand what a lot of those side effects and risks mean. For example, commercials that start the list of warnings with “don’t take this drug if you are allergic to it” is a surefire way to get viewers to tune out, since it is obvious. This is true when listing side effects on a drug ad, in a press release, or on labels required for all prescription drugs and devices. The way risk information is rattled off in TV commercials, for example, is clearly done because it is required, not because the company wants patients to pay attention and understand those risks.
Thank you so much for the opportunity to share our Center’s views with you today.