Recommended Alerts

Sign Up For Alerts

FDA Finalizes Guidance on Informed Consent for Clinical Investigations

On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) issued a new guidance document on informed consent (the “Final Guidance”).

Read More

OIG Speaks out on Speaker Programs: Some Implications of the New Special Fraud Alert

Time to Read: 1 minutes Practices: Health Care

Printer-Friendly Version

On November 16, 2020, the Department of Health and Human Services Office of Inspector General (“OIG”) issued a Special Fraud Alert (“SFA”) highlighting what it considers to be fraud and abuse risks associated with speaker programs hosted by pharmaceutical and medical device companies. The SFA treads some old ground by highlighting certain conduct—such as $500-per-head meals or allowing attendees to bring social guests—that OIG has long made clear may make a speaker program suspect. But it also expresses some new and seemingly broader concerns about such programs as a general matter. This warrants a close look since OIG has addressed speaker programs in its guidance to industry and through corporate integrity agreements for nearly two decades without suggesting that speaker programs are generally of concern. In addition, since, historically, SFAs have been associated with government enforcement initiatives, and this SFA has issued on the heels of some high-profile speaker program settlements, the SFA merits close attention.

This Alert summarizes key elements of the SFA, and contains a table summarizing past SFAs and the enforcement initiatives that have been associated with them.

Printer-Friendly Version

Cookie Settings