Will the FDA hearings on social media, which kicked off today, result in guidance specific to online media? That’s the question on the minds of digital gurus converging on the capitol for two days of presentations on using social media in drug and device marketing.
A promotional card for Sanofi Aventis’s Uroxatral omitted indication and risk information, and also used outdated product labeling, according to a DDMAC warning letter.
Video news releases for King’s abuse-resistant pain drug Embeda drew a warning letter from FDA’s Division of Drug Marketing, Advertising and Communications.
The FDA issued an untitled letter to J&J for a journal ad for its athlete’s foot treatment Ertaczo Cream, saying the ad omits key risk info, broadens the indication and overhypes efficacy.
The FDA hit Johnson & Johnson with a warning letter over a webcast promoting pain med Ultram ER, saying it overstated efficacy and underplayed or omitted risks.
DDMAC raps sponsored links for omission of risk info
The FDA’s Division of Drug Marketing, Advertising and Communications slapped 14 drug companies with untitled letters for sponsored links on Google deemed violative because they omitted risk information.
Bayer runs “corrective” Yaz ad, agrees to preclearance
Bayer is shelling out $20 million to air a rare remedial TV ad campaign for its Yaz birth control pill as part of a settlement with FDA and 27 states over charges of deceptive advertising. Bayer also agreed to submit all ads to FDA for preclearance for the next six years.
KV Pharmaceutical Company said it is eliminating 700 jobs as part of a cost-cutting program following a suspension of manufacturing and product recalls resulting from an FDA investigation.