Although feelings in the mainstream drug industry will be mixed, it’s time to end the secrecy that surrounds the FDA’s decision-making on approving drugs.
Patient marketers and industry commentators talk an awful lot about the “empowered” consumer.
Drug testing puts consumers at risk
September 16, 2008
3:56 pm
A sociologist says fatal flaws in the way new drugs are tested and marketed mean that American consumers are likely to be exposed to unacceptable side effects of FDA-approved drug such as Vioxx in the future.
Kennedy, Kessler fight pre-emption
September 16, 2008
3:53 pm
Former FDA commissioners Donald Kennedy and David Kessler have told the Supreme Court that drug company and FDA arguments promoting FDA pre-emption of state failure-to-warn claims in drug safety cases “threaten to undermine, not advance, the underlying goal of our nation’s drug safety laws, which is ‘to protect consumers from dangerous products.'”
Balancing messages on- and offline
September 12, 2008
3:51 pm
Effective patient marketing campaigns utilize traditional DTC as well as social networks and other emerging media online. How do marketers find the right media balance?
Lawyers defend failure-to-warn suit
September 16, 2008
3:51 pm
Attorneys for a woman who lost an arm to gangrene after an IV administration of Wyeth’s anti-nausea drug Phenergan say there is no conflict between a failure-to-warn suit under Vermont law and FDA’s regulation of drug labeling.
GAO: FDA’s Mifeprex approval ‘consistent’
September 16, 2008
3:48 pm
The Government Accountability Office said the FDA’s approval process for Mifeprex, the RU-486 abortion pill, was “consistent with the processes for the other Subpart H restricted drugs.”