FDA Announces Safety Labeling Changes Program
As reported by Regulatory Focus, the FDA announced the “safety labeling changes” (SLC) program. It will be reportedly managed by the Center for Drug Evaluation and Research’s (CDER) Office of Communications. This program includes a database that provides public data that is both downloadable and searchable. The Drug Safety Labeling Changes (SLC) database provides approved safety labeling changes from January 2016 forward. Data prior to January 2016 will continue to be available on the MedWatch website.
According to the FDA, this will enable health information technology vendors to more efficiently gather, organize and distribute information related to drug safety label changes. The SLC program will provide drug safety labeling changes to health care vendors as quickly as possible to facilitate having the data further integrated into systems frequently accessed by health care providers. Ultimately, the FDA expects that prompt access to these vital safety data by health care providers and consumers will better promote patient health.
Regulatory Focus also reported CDER director Janet Woodcock’s statement in an email to FDA staff. “With this transition, safety labeling change (SLC) data on the Web will now be available much faster for health care providers, health information technology vendors, and the public to view, search, and download,” she wrote.
Industry guidance on safety label changes was last published in 2013. In the guidance, FDA explained its thinking on the definition of new safety information under the FDAAA. The agency also explained how it will review required labeling statements and notify application holders of required changes. Details such as dispute resolution and the enforcement requirements of safety label changing are also outlined by FDA in the guidance.
Furthermore, according to recent research, label changes, as the communication tool of the FDA, are a common occurrence with about 400 to 500 product label changes occurring every year. The FDA receives approximately 500,000 reports each year. Because the drug companies are mandated to report any adverse effects, the majority of spontaneous reports from doctors and patients are first reported to the drug companies, which then must enter a report with the FDA. The rest occur via spontaneous reports from doctors and consumers who report directly to the FDA any new safety information. Two separate studies of product label changes conducted in 2007-2009 and 2010 found that 59 and 52 percent of label changes arose from these spontaneous reports, respectively.
The majority of label changes begin with spontaneous reports that are either reported to drug companies or directly to the FDA, and while this gives consumers and doctors a prominent voice in drug safety, spontaneous reports are easily generated leading to a regular need for label revisions. The current system allows case reports, especially those reporting a severe, adverse event, to drive the process of label changes. The case reports can indicate a correlation with the usage of a drug, but are not perfect indicators of causation. The FDA has been trying to create a more reliable process through the Sentinel Initiative. However, the pilot project for this initiative is ongoing, and as a result, the effects of the Sentinel Initiative remain to be seen. While waiting for more advanced technologies and data, the public and FDA must still mainly rely on spontaneous reports, which will inevitably increase the number of needed label changes. These repeated revisions have become standard practice in the current system of post-marketing surveillance from the FDA, and each change should not be interpreted as a significant event.