It’s been a busy year for the FDA. In addition to approving 63 new and original drug applications (NDA’s and BLA’s) since the beginning of 2010, the Agency has rejected countless more, including the much touted “pink pill” or Female Viagra and the fat fighting drug Qnexa.
They also appear to have taken on the pharmaceutical industry – in a big way.
Industry insiders and observers are all acutely aware of the increase in the number of Warning Letters and Notice of Violation letters coming out of the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC).
Since January 2010, DDMAC has issued 71 warning letters, notifying pharmaceutical companies about promotional violations. The number has been steadily rising since 2009.
Word on Health suspects that this may, in part, be due to the fact that the FDA recently reversed a policy that required warning letters to undergo legal review before they were issued. Then again, maybe the Agency’s BadAd program is bringing more promotional “no-no’s” to their attention.
Others would like to blame social media and the lack of FDA guidance for the increase. Indeed, just last week the FDA issued a Notice of Violation letter regarding the “Share” function on Facebook. It’s also rumored that DDMAC has staffed up.
Whatever the reason, it means the pharmaceutical industry needs to be more careful than ever.
SRxA can help companies develop and deliver, compliant and effect programs. Contact us today to learn how we can help you avoid becoming another FDA statistic.