2015 Was a Golden Year for Pharma Epic Number of Drug Approvals, Orphan Drugs Galore, But Lite on FDA Enforcement Actions!
If you thought things couldn’t get much better for the pharmaceutical industry and pharma marketers after the banging year of 2014, then you’d be wrong! 2015 was even better as far as new drug approvals and lack of enforcement actions by the U.S. Food and Drug Administration (FDA) go.
In 2015, FDA approved 45 new drugs–the highest number since 1996.
But FDA’s Office of prescription Drug promotion (OPDP) sent out only 9 advertising enforcement letters (2 Warning Letters, 7 Untitled Letters), which beats 2014’s record low of 10 letters.
Topics (partial list):
- Figure: FDA Drug Approvals (1994 through 2015)
- Orphan Blockbusters
- Wimpy FDA Marketing Enforcement
- A Deeper Dive
- Figure: Primary Violations Cited by FDA in 2015
- Are Pharma Marketers Flummoxed?
- How Kim Kardashian Got Hired to Shill for Diclegis
- Why So Few Letters? Follow the Money
Download the full article (PDF file) here:
Issue: Vol. 15, No. 1: January 2016
- Regulatory Compliance
- Direct-to-Consumer (DTC) Advertising & Marketing
- Physician Marketing & Promotion