Thursday, 17 May 2018
5:30–8:30 pm EDT
PORZIO, BROMBERG & NEWMAN, P.C.
100 Southgate Parkway
Morristown, NJ 07962-1997
+1 973 538 1690
In the United States, physicians may prescribe pharmaceuticals and medical devices for uses other than their approved or cleared indications. This practice is known as off-label use. For some disease states, off-label use of products is widely recognized and may even constitute the standard of care. Despite this practice, manufacturers are prohibited from promoting their products for off-label uses. In recent years, this prohibition has raised questions with respect to free speech protections, scientific exchange and an ever-evolving demand for up-to-date information by the medical community and general public. This presentation will highlight recent changes in the off-label landscape, discuss impact on promotional review practices and scientific communications and include tips to prevent regulatory and compliance violations.
Topics to be covered will include:
- Recent changes in the off-label landscape
- Recent off-label court cases
- State law developments
- Recent FDA guidance
- Draft guidance: medical product communications that are consistent with FDA-required labeling (Jan 2017)
- Draft guidance: drug and device manufacturer communications with payors, formulary committees and similar entities (Jan 2017)
- 21st Century cures act - changes to FDAMA 114
- Delay of intended use rule
- Impact on promotional review practices and scientific communications
- Hypothetical for group discussion
- Tips to prevent violations
- Examination of processes
- Auditing and monitoring practices
The RAPS New York/New Jersey chapter invites you to join others from the local regulatory community to explore this important topic with your colleagues. Light refreshments will be available to all attendees. RAC holders may claim two RAC recertification credits.
Jennifer A. Romanski, Esq., principal, PORZIO, BROMBERG & NEWMAN, P.C., Life Sciences Compliance and Regulatory Counseling Department
RAPS Members: $35