[dvd-discuss] Thompson v. Western States Medical Center

["Arnold G. Reinhold" <reinhold(at)world.std.com>]

Here is a quote from Justice O'Conner's majority opinion, released 
yesterday, in Thompson v. Western States Medical Center, which struck 
down a ban on pharmacists advertising drug compounding services. Her 
logic seems directly applicable to the DMCA's ban on dissemination as 
applied in the DeCSS case. See especially the last two sentences.


"Several non-speech-related means of drawing a line between 
compounding and large-scale manufacturing might be possible here. 
First, it seems that the Government could use the very factors the 
FDA relied on to distinguish compounding from manufacturing in its 
1992 Compliance Policy Guide. For example, the Government could ban 
the use of ³commercial scale manufacturing or testing equipment for 
compounding drug products.² Compliance Policy Guide, App. to Pet. for 
Cert. 76a. It could prohibit pharmacists from compounding more drugs 
in anticipation of receiving prescriptions than in response to 
prescriptions already received. See ibid. It could prohibit 
pharmacists from ³[o]ffering compounded drugs at whole-sale to other 
state licensed persons or commercial entities for resale.² Id., at 
77a. Alternately, it could limit the amount of compounded drugs, 
either by volume or by numbers of prescriptions, that a given 
pharmacist or pharmacy sells out of State. See ibid. Another 
possibility not suggested by the Compliance Policy Guide would be 
capping the amount of any particular compounded drug, either by drug 
volume, number of prescriptions, gross revenue, or profit that a 
pharmacist or pharmacy may make or sell in a given period of time. It 
might even be sufficient to rely solely on the non-speech-related 
provisions of the FDAMA, such as the requirement that compounding 
only be conducted in response to a prescription or a history of 
receiving a prescription, 21 U. S. C. §353a(a), and the limitation on 
the percentage of a pharmacy¹s total sales that out-of-state sales of 
compounded drugs may represent, §353a(b)(3)(B).


The Government has not offered any reason why these possibilities, 
alone or in combination, would be insufficient to prevent compounding 
from occurring on such a scale as to undermine the new drug approval 
process. Indeed, there is no hint that the Government even considered 
these or any other alternatives. Nowhere in the legislative history 
of the FDAMA or petitioners¹ briefs is there any explanation of why 
the Government believed forbidding advertising was a necessary as 
opposed to merely convenient means of achieving its interests. Yet 
³[i]t is well established that Œthe party seeking to uphold a 
restriction on commercial speech carries the burden of justifying 
it.¹² Edenfield v. Fane, 507 U. S., at 770 (quoting Bolger v. Youngs 
Drug Products Corp., 463 U. S. 60, 71, n. 20 (1983)). The Government 
simply has not provided sufficient justification here. If the First 
Amendment means anything, it means that regulating speech must be a 
last‹ not first‹resort. Yet here it seems to have been the first 
strategy the Government thought to try."

http://www.supremecourtus.gov/opinions/01pdf/01-344.pdf

Arnold Reinhold