Update on FDA and preemption

Pharma Marketing Blog and Eye on FDA discuss the proposal to have FDA pre-review all direct-to-consumer ads. While the former notes that AstraZeneca's proposed tradeoff is that reviewed ads cannot then be found misleading or inaccurate (because problems never develop in practice, especially when you're guessing about how audiences will receive a message!), it's worth noting that the other obvious benefit to pharma from pre-review is that then it will be easier to argue that deceptive advertising claims are preempted. Judge Breyer recently partially rejected a preemption claim because FDA doesn't review DTC in advance, which can only have increased the industry's enthusiasm for pre-review.

Tags:

• fda
• preemption
• falseadvertising