Vol 22, 2013 Annals of Health Law 423
PROSECUTIONS OF PHARMACEUTICAL COMPANIES
material” which can be regulated; but it noted that the same information is
not promotional and subject to regulation when circulated by the CME
provider, or even by the drug company in response to a specific question.101
Soon thereafter, the Washington Legal Foundation brought a lawsuit raising
a First Amendment challenge to the regulation.102 The court ruled in favor
of the Foundation noting that under the FDA approach “a great deal of
truthful information will also be embargoed. In this case, the truthful
information may be life saving information, or information that makes a life
within a debilitating condition more comfortable.”103 Next, the Food and
Drug Modernization Act was passed, amending the FDCA and subjecting a
manufacturer to criminal penalties for the dissemination of information.104
In 1999, the district court ruled in Washington Legal Foundation v.
Friedman that this statute barred truthful speech about off-label uses and
violated the First Amendment.105 On appeal, the FDA abandoned its
position and stipulated that neither the Guidance document nor the new
legislation “provides the FDA with independent authority to regulate
The United States Supreme Court subsequently found a different
provision of the legislation to be unconstitutional.107 The basis for the
decision is instructive of how the Court would likely view the restrictions
discussed herein. In Thompson v. Western States Medical Center, the FDA
sought to regulate the “compounding” of “new” drugs by pharmacies.108 In
particular, the FDA sought to ban any advertising that compounded drugs
are available.109 The government argued that the “FDA’s experience with
drug regulation demonstrates that proof of the safety and effectiveness of a
new drug needs to be established by rigorous, scientifically valid clinical
studies because impressions of individual doctors, who cannot themselves
compile sufficient safety data, cannot be relied upon.”110
The challenge to the legislation noted that obtaining approval from the
FDA is costly and would effectively eliminate the availability of
compounded drugs for those patients who have no alternative treatment.111
101. Final Guidance on Industry-Supported Scientific and Educational Activities, 62
Fed. Reg. at 64,564.
102. Wash. Legal Found. v. Friedman, 13 F. Supp. 2d 51 (D. C. Cir. 1998).
103. Id. at 73.
104. 21 U.S. C. § 331(z) (1997).
105. Wash. Legal Found. v. Henney, 56 F. Supp. 2d 81, 84-87 (D. C. Cir. 1999).
106. Wash. Legal Found. v. Henney, 202 F.3d 331, 336 (D. C. Cir. 2000)
107. Thompson v. W. States Med. Ctr., 535 U.S. 357, 360-61 (2002).
109. 21 U.S. C. § 353(a).
110. Id. at 368-69.