In what had to be one of the most non-newsworthy headlines to come out of FDA in a long time, this week the agency announced "FDA to Communicate Safety Monitoring Activities to Consumers and Health Care Professionals" which naturally raises the question – you mean that they haven't been doing this until now??? Don't worry, of course they have.
Actually what the press release is actually announcing is a new resource where consumers and professionals can go for safety information on approved drugs by reading summaries that will be provided by FDA of the experience of a treatment once it is on the market. In some ways, one supposes, it will be kind of a product safety progress report.
How will the FDA convey this information? It is stated that "[i]ncluded in the summaries may be information on potentially serious, previously unidentified risks, if any are found during the review, as well as known adverse events that occur more often than they did during clinical studies."
The FDA also provides a link in the release to an example of what the summaries will look like. It is a very simple table comprised of four columns – Product Name; Indication; Summary of Findings; Actions Being Taken – and in none of the entries is there very much detail. It's very readable and provides an overview of what is going on for all drugs very concisely.
In a way, the report gathers information from some of the many other risk and safety information already produced by the agency and posted on its Web site for consumers. There is, after all, already
- An Index to Drug-Specific Information – taking you to very complete information about a particular drug;
- An FDA Drug Safety Newsletter – the stated purpose of which is to provide "postmarketing information to healthcare professionals to enhance communication of new drug safety information, raise awareness of reported adverse events, and stimulate additional adverse event reporting"
- Safety Alerts for Approved Products -
- Monthly Report on Safety Labeling Changes – A listing of all label changes by drug
- MedWatch Safety Alerts for Approved Products – "Your FDA gateway for finding clinically important information and reporting serious problems with human medical products"
- Potential Signals of Serious Risks/New Safety Information Identified from AERS – "reports list any potential signals of serious risks/new safety information that were identified using the AERS database during the indicated quarter. The appearance of a drug on this list does not mean that FDA has concluded that the drug has this listed risk. It means that FDA has identified a potential safety issue…."
- Recalls, Market Withdrawals and Safety Alerts – a compilation of the most recent and significant product actions.
There's more, but you get the idea. Confused? Which one of these would you naturally choose if you wanted information about a drug? There is already a LOT of risk information for patients and health care professionals on the FDA site. Would you know how to find them all?
I'm all for access to risk information (as well as benefit information) so that people can make informed decisions about their care. But compiling reports and lists is only part of the job. Making it accessible, understandable and consumer friendly is the other part.
If you go to the FDA Web site, the navigation is not exactly consumer friendly. Some of these reports have links on the extraordinarily busy home page. Under the heading marked "Consumers" there are no links about finding information about the drugs you are taking. You would have to click on "Drugs" in the boxes on the upper left corner that provide categorical listings of regulatory areas, and then a box will open up that includes a heading for Safety Information. You have a choice of four.
One of the four is the "Postmarket Drug Safety". That leads you to a labyrinth page of other resources with names that are not, to say the least, consumer friendly such as "Postmarket Requirements and Commitments Search" (your first choice), and other choices. Way, way down on the list is the new report announced this week by FDA. To find it, you would have to be a patient with an extraordinary high level of digital and healthcare literacy.
Looking at the FDA Web site, one might conclude that more risk information resources are not necessarily needed. What is needed is a primer for patients to take them through the issues of drug safety, and to help them make informed decisions (not only based on risk information) and to make it appear on the FDA landing page. Right now, the risk information supplied by the agency may fulfill legislative needs and mandates, but I'm not sure it fulfills patient needs.