Regulating Consumer-Directed Rx Drug Promotion：调节消费者定向RX药品促销.ppt

An Overview of Direct-to-Consumer Prescription Drug Promotion
Nancy M. Ostrove, .
Risk Communication Advisory Committee
May 15, 2008
DTC an Evergreen Issue
May 8, 2008 Hearing
House Energy & Commerce Subcommittee on Oversight and Investigations
Testimony from researchers, AMA, GAO, Merck/Schering-Plough, Ortho Biotech, Pfizer
Web cast and prepared testimony at:
Regulatory Oversight
Oversight of drug promotion is split
1962 Kefauver-Harris amendments to Federal Food, Drug, and Cosmetic Act (FFDC Act)
agreement with Federal Trade Commission
FTC has primary jurisdiction over OTC drug advertising
FDA has primary jurisdiction over Rx drug labeling and advertising; also over OTC drug labeling
Background Facts - 1
Until FDAAA, the FFDC Act did not distinguish between advertising to health care professionals and advertising to patients or consumers
Currently, implementing regulations (21 CFR ) do not distinguish between advertising to health care professionals and advertising to patients or consumers
That is, the underlying rules historically have been the same regardless of audience
Background Facts - 2
Promotion directed toward consumers was never prohibited – practice changed
FFDC Act generally prohibits any require-ment for preclearance of advertising
except in “extraordinary circumstances”
FFDC Act requires advertisements to include “information in brief summary” about product risks and benefits
Classes of PromotionalMaterials - 1
Different classes of promotional materials
Labeling (of the promotional variety)
brochures, mailing pieces, literature, detail aids, price lists, calendars, and “similar pieces of printed, audio, or visual matter descriptive of a drug,” and references (., PDR)
Classes of Promotional Materials - 2
Advertisements
in journals, magazines, newspapers, other periodicals or through broadcast media (TV, radio, telephone communications systems)
Different types of advertisements have different regul