The implications for what's can be said in direct to physician promotion of drugs and medical devices may well be profound.

This case was actually about a (successful) challenge on a Vermont State law restricting access to drug prescribing information.  However as an aside - the judgement got into issues of free speech.

The relevant passage is on page 22 of the judgement. 

But the “fear that people would make bad decisions if given truthful information”  cannot justify content-based burdens on speech.  Thompson, 535 U. S., at 374; see also Virginia Bd. of Pharmacy v.  Virginia  Citizens Consumer Council,  Inc., 425 U. S. 748, 769–770 (1976).   “The First  Amendment directs us to be especially  skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good.”  44 Liquormart, supra, at 503 (opinion of Stevens, J.); see also Linmark Associates, Inc. v.  Willingboro, 431 U. S. 85, 97 (1977). These precepts apply with  full force when the audience, in this case prescribing physicians, consists of “sophisticated and experienced” consumers.  Edenfield, 507 U. S., at 775.

The very clear reference to the sophisticated audience of physicians will mean there some urgent rethinking to be done as to the restrictions on advertising and promotion in the US of FDA regulated products.  

Released May 23rd is an interesting report from Northwestern University (Institute for Health Technology Studies) describing the outcome of research with regard satisfaction about the 510(k) process. The content amplified information provided by US speakers at the AusMedtech conference this week, that European approvals are gained with greater clarity of requirement, and much faster than the product review process at FDA. www.inhealth.org/wtn/Page.asp?PageID=WTN004937

The study reports that two-thirds of small medical device and diagnostic firms look to Europe for their first regulatory approvals. Predictability was reported to be the crucial factor in satisfaction with a process. Only 8 percent of survey respondents believe FDA's 510(k) product review process is the most predictable regulatory system, as compared with roughly two-thirds of respondents who stated that Europe's CE marking process is the most predictable.

It will be interesting to see what the FDA internal review and independent report it commissioned from the Institute of Medicine will reveal. Stay tuned - it's due 3rd quarter 2011.....