Introduction

The Food and Drug Administration (FDA) has already embraced social media as a way to reach out to consumers. Currently, interactions are limited to answering questions and providing updates on drug safety or healthful living. Considering one of the FDA’s most pivotal roles is monitoring drug safety both in and out of clinical trials, it is somewhat surprising that no formal process exists to synthesize consumer reports of drug-related adverse events (AEs) found on social media websites.

Background

Once a drug has made it through three successive levels of carefully regulated clinical trials, the new drug continues to be monitored in the marketplace. This stage is known as Phase IV or post-marketing surveillance. Despite large pre-marketing studies with samples designed to mimic the target population as closely as possible, there is still an element of uncertainty when a drug is marketed to the population at large. The FDA currently has an electronic system known as MedWatch in place for consumers to report events, and the reports are compiled in the FDA Adverse Event Reporting system (FAERS). Despite these efforts, only 1  million out of an estimated 13 million hospital visits attributable to AEs are  officially reported. With the advent of social media and the massive amounts of untapped safety and efficacy data, waiting for information to trickle in through a highly bureaucratized process is no longer a safeguard, but a hindrance.

Issue

Should the FDA consider social media (Facebook, Twitter, etc.) an acceptable vehicle for adverse event reporting?

Rule

The FDA should consider social media an acceptable vehicle for AE reports if:

  1. The posts immediately meet the FDA’s criteria  for an AE report or a follow-up to confirm the information is reasonable

AND

2.   This would result in a substantial increase in adverse event reporting

Analysis

Identifiable Patient/Person Reporting the Event

The first two criteria for an AE report are an identifiable  patient and an identifiable reporter. Assuming that the reporter and patient can be the same person, user-generated posts can meet these requirements. Sites such as Facebook, Twitter, or blogs contain highly detailed patient reports regarding the effects of different medications. Posts often have a discrete and identifiable username and IP address. Most sites also offer a private messaging feature that could be used to contact the report’s author in order to verify information and the identity of the patient or reporter. This could be considered a virtual extension of current FDA practices that allow agents to contact a patient whose information was provided via electronic reports. Thus, the identifying criteria are met.

Suspect Drug and Adverse Experience

The second two criteria for an AE report are a suspect drug or biologic and a suspected relationship between the drug and resulting adverse event. The posted narrative of taking a medication and a resulting effect qualifies as an AE report. By virtue of inclusion in the same post, a relationship between the adverse event and the suspect drug or biologic exists and warrants consideration or follow-up by the FDA or drug sponsor.

Increase in Reports

Assuming, per the Visible Technologies report, that 0.2% of retrieved posts immediately fulfill the FDA’s adverse event report requirements, a substantial increase in reporting will still result. An addendum to a study by Nielsen’s, a social media analysis company, estimated that even under the strictest criteria, pharmaceutical companies could submit an additional 166 new reports daily, or more than 60,000 per year. This represents a substantial gain in safety and efficacy data not currently being utilized due to the lack of official guidelines on how to handle user generated reports on social media sites.

Conclusion

The FDA adverse event system is currently a passive one, but would require only slight changes to make it active. Ultimately it would benefit the FDA and the population it protects to commit to active information gathering from the rich sources of information found in social media.

For more information on this issue, contact the Kulkarni Law Firm.