Free Newsletter
Too much off-label regulation?
The Internet is buzzing about a Wall Street Journal op-ed piece in which ex-FDA deputy commissioner Scott Gottlieb (photo) championed the sort of off-label promotions that make regulators crazy. Gottlieb cited a couple of cases in which drug makers have paid multi-million dollar fines for pushing meds in non-FDA-approved directions. The whole off-label promotion ban is wrong, Gottlieb says, and it hurts patients who might benefit from off-label uses if their docs only knew.
Yet, as the WSJ Health Blog points out, off-label marketing isn't allowed for a reason. Some of it amounts to cherry-picking studies that support new uses for a drug. Marketers often ignore the trials that conclude otherwise. But has the FDA gone too far in policing the practice? Debate is likely to continue.
- read the Health Blog item
- here's the Pharmalot report
- read Gottlieb's original op-ed
Related Articles:
Rep decries off-label marketing "loophole." Report
New warning for off-label Fentora. Report
Paid Research Reports
- Trends in mHealth and Telemedicine
- The Global Aesthetic Dermatology Market Outlook
- Future Directions in Regenerative Medicine
- Pipeline Insight: Insulin Antidiabetics – Novel analogs show promise as alternative delivery methods prove less attractive
- Pipeline Insight: Non-insulin Antidiabetics - Rise of the weight-reducers: Once-weekly GLP-1 agonists and novel SGLT-2 inhibitor
- Forecast Insight: Antidiabetics - Diabetes market growth driven by epidemiological trends and rich pipeline


SHARE
WITH: