by Ben Vernia | April 22nd, 2010
On March 29, the United States filed a reply brief to its motion for summary judgment in Allergan’s suit against the FDA’s restrictions on the company’s off-label speech concerning Botox. In its reply,. the US claims that Allergan both understates the impact of its challenge to the FDA’s regulations and overstates the regulations’ impact on protected speech.
Describing several examples of off-label use of drugs which had devastating adverse consequences for patients (e.g., diethylstilbestrol, or DES), the US’s brief asserts that, contrary to the company’s claims, its constitutional challenge would open the door to pharmaceutical advertising for off-label uses, including dangerous ones such as the government described.
The government then argued, “on the other side of the constitutional balance,” that the company was exaggerating the regulations’ impact on truthful speech. Although the US asserted that “‘[p]rescribing,’ ‘recommending,’ and ‘suggesting’ that a drug be used for unapproved purposes are all forms of promotion” (and therefore unlawful), it argued that the company is free – and is sometimes required by the FDA – to provide safety information.
The government’s brief continued, arguing that its regulations are not subject to strict scrutiny, but are narrowly tailored under the Central Hudson test, and that the company’s claims that the regulations are invalid as applied to medically accepted off-label uses, and are inconsistent with the act are without merit.
The District Court for the District of Columbia subsequently vacated the prior scheduling order, and ordered the parties in the case to provide a status report on May 14.