Vol 22, 2013 Annals of Health Law 422
PROSECUTIONS OF PHARMACEUTICAL COMPANIES
B. It is Constitutionally Questionable for Government to
Limit Truthful Commercial Speech About Off-Label Uses
The regulations and enforcement actions discussed herein give rise to
serious questions about whether, and when, the government can prevent the
truthful exchange of scientific information between a drug company and a
physician or other health care providers. In July 2008, the United States
Government Accountability Office (“GAO”) submitted a Report to the U.S.
Senate entitled “Prescription Drugs: FDA’s Oversight of the Promotion of
Drugs for Off-Label Uses.”97 Although focused on the facts of FDA
regulatory positions, and not the constitutionality of those positions, the
GAO reflects the incongruity of the restrictions on speech:
FDA does not generally regulate the exchange of scientific
information, but when such information is provided by or on
behalf of a drug company regarding one of the company’s
products, the information may be subject to the labeling and
advertising provisions of the law and regulations. For example,
while information provided at CME programs – such as medical
conferences and professional gatherings intended to enhance
physicians’ knowledge and enable them to meet certain practice
requirements – is not generally subject to FDA regulation, it will
be if the program has been funded and substantially influenced by
a drug company. Similarly, FDA’s position is that companies may
respond to unsolicited requests for information from health care
professionals, even if responding to requests requires the
companies to provide information regarding off-label uses.98
It is reasonable to question whether these rather fine distinctions
regarding when and by whom truthful information may be shared with
physicians inure to the best interests of the medical community and the
public. If off-label uses are recognized as appropriate and necessary in
certain circumstances, why limit when and how industry can speak?
Burroughs et al. succinctly traced the First Amendment concerns in this
context.99 The constitutional question sprang from the December 1997
FDA Guidance on Industry-Supported Scientific and Educational Activities
(“Guidance”).100 Not surprisingly, the Guidance described a drug
company’s dissemination of scientific information as “promotional
97. U.S. GOV’T ACCOUNTABILITY OFFICE, GAO-08-835, FOOD AND DRUG
ADMINISTRATION: OVERSIGHT OF THE PROMOTION OF DRUGS FOR OFF-LABEL USES (2008),
available at http://www.gao.gov/assets/280/278832.pdf.
98. Id. at 9.
99. Burroughs, supra note 29, at 568-72.
100. Final Guidance on Industry-Supported Scientific and Educational Activities, 62
Fed. Reg. 64,074 (Dec. 3, 1997).