Compliance is a top priority for all aspects of drug development. No company wants to run afoul of regulators at any stage, whether a pre-clinical study, post-market monitoring, or anything in between.
The same holds for Speaker Programs. While usually intended to educate the medical community, Speaker Programs could give rise to liability under the federal Anti-Kickback Statute (AKS) and False Claims Act (FCA).
There are several essential compliance considerations for a Pharma Speakers Bureau:
- Adherence to regulations. Pharma speaker bureaus must comply with a range of rules, including the US FDA’s regulations regarding promotional materials, the FCA, the AKS, and the Sunshine Act. All speaker activities must comply with these regulations.
- No off-label promotion. Speakers can’t promote drugs for uses not approved by the FDA and must only speak to approved drug uses.
- Fair balance. Pharma speaker programs must present a fair and balanced view of a drug’s benefits and risks. Speaker materials should be reviewed to ensure that they are honest and balanced.
- Transparency. Under the Sunshine Act, companies must report certain payments and transfers of value to physicians. Any payments made to speakers must be reported accurately and promptly.
- Monitoring and auditing. Pharma teams should monitor speaker programs by conducting audits to ensure compliance.
Each Pharma Gnosis Speakers Bureau is configured uniquely for the Speaker Agreements and Cancellation fees, Compliance Rules, and Aggregate Spend reporting requirements for Open Payments and Sunshine Act compliance.