Vol 22, 2013 Annals of Health Law 428
PROSECUTIONS OF PHARMACEUTICAL COMPANIES
with the rising off-label use of another of its products, Avastin.147 The
product was approved in 2004 to treat colon cancer,148 and it was approved
in 2006 to treat lung cancer.149 Then, in 2007, the company obtained
approval to market a new drug called Lucentis that was based on the same
active ingredient as Avastin, for macular degeneration, which is a leading
cause of blindness in people over age sixty.150 Physicians developed
methods of treating macular degeneration with the less expensive, older
drug Avastin, although it was not approved for that use.
Genentech was placed in a very difficult position and was criticized for
failing to facilitate the use of the much cheaper, older Avastin for macular
degeneration. The company publically stated that while the medical
community was acting “with noble intent, which is to help patients who are
going blind as we speak . . . [,] there have been no safety and toxicity
studies conducted on Avastin as an ophthalmic drug.”151 When asked how
it communicated with the medical community about the issue, Genentech,
previously stung by off-label promotion allegations in a different context,
answered “[w]e make education material available to the doctors but we
don’t take a position.”152 There was significant evidence about many
aspects of the propriety of prescribing the product for this off-label
purpose, but this purpose could not be freely discussed with physicians.
After reviewing much of this information, one commentator concluded:
From a public policy perspective, it would be preferable to permit
companies to act in an ethically responsible manner and to share
fully any concerns about prevailing physician practice, rather than
to limit communications to a brief press statement and the
dissemination of peer-reviewed journal articles. But the current
regulatory environment does not allow companies to do this.153
147. See, e.g., S. Grisanti & F. Ziemssen, Bevacizumab: Off-label Use in
Ophthalmology, INDIAN J. OPHTHALMOLOGY 55(6): 417–420 (Nov.-Dec. 2007) (reporting
widespread off-label use of Avastin for opthamalogical conditions).
148. KAREN D. WEISS, FOOD & DRUG ADMIN., STN: BL 125085/0, FDA APPROVAL
LETTER FOR AVASTIN (2004), available at http://www.accessdata.fda.gov/drugsatfda_docs/
appletter/2004/125085ltr.pdf.
149. PATRICIA KEEGAN, FOOD & DRUG ADMIN., STN: BL 125085/85, FDA APPROVAL
LETTER FOR AVASTIN (2006), available at http://www.accessdata.fda.gov/drugsatfda_docs/
appletter/2006/125085s085ltr.pdf.
150. See Osborn, supra note 22, at 336.
151. Genentech: Avastin Not Intended for AMD; Company Cautions on Off-Label Use
of Cancer Drug, RETINAL PHYSICIAN (Jan. 2006), available at http://www.retinalphysician.
com/ article.aspx?article=100181.
152. Id.
