In January 2017, FDA issued draft guidance to address drug and device manufacturers’ communications with payors and other formulary decision-makers. The guidance provides much-needed clarity on FDA’s position concerning appropriate dissemination of health care economic information (HCEI) following the enactment of the 21st Century Cures Act, which both revised the definition of HCEI and expanded the audience that can receive it. Importantly, FDA’s draft guidance also sanctions pre-approval communications with payors regarding investigational drugs and devices. The period for public comment on this draft guidance closed in April.
Join Pepper attorneys Yvonne M. McKenzie and Jessica A. Rickabaugh and counsel David Foberg of Merck & Co., Inc. as they examine FDA’s guidance; the possible litigation risks of marketing to payors, particularly when the information is not in the product label; and how FDA may approach regulation of payor marketing in the future.
This seminar is approved for one substantive CLE credit in Pennsylvania. Attorneys licensed in New Jersey may claim credit for this program under New Jersey's reciprocity policy.
Philadelphia Country Club
1601 Spring Mill Road
Gladwyne, PA 19035
There is no cost to attend.
Contact Kim MacAlister at firstname.lastname@example.org or 215.981.4249 with any questions.