When I last posted on the subject of Par Pharmaceutical’s lawsuit challenging the FDA’s off-label rules on free speech grounds, the Government had filed a motion to dismiss the suit and for summary judgment on several grounds, including Par’s lack of “standing” and the “unripeness” of its claims. The Government ginned up its legal attack with a lengthy and emotional appeal, buttressed by the Declaration of the FDA’s Dr. Rachel Sherman, that unless the FDA’s off-label regulatory scheme was upheld, public health and safety would be jeopardized. In a clever counter-move, Par filed a motion for limited discovery, arguing that the Government’s interjected three material facts that now require Dr. Sherman’s deposition and other discovery.
As Par notes in its motion, the Government’s brief in support of its motion (1) avoids the regulatory rule-making process by declaring (through Dr. Sherman’s Declaration) what kind of speech is and isn’t permissible; (2) criticizes Par’s past efforts to obtain FDA approval for Megace-ES to treat weight wasting in geriatric and oncology patients; and (3) claims that Medicare and Medicaid do not provide reimbursement for off-label uses of Megace-ES. However, Par maintains that none of these assertions are accurate and that, absent limited discovery to ascertain the grounds for the Government’s claims, it cannot adequately respond to the motions to dismiss and for summary judgment. Par demands the right to obtain limited documents and to take Sherman’s deposition in order to “examine her . . . about (a) the FDA’s position on the propriety of on-label speech to doctors who are likely to prescribe a drug off-label, and (b) Par’s interactions with FDA relating to Par’s pursuit of potential approvals for oncology and geriatric indications.” Par also seeks to take the depositions of Dr. Robert Perlstein of the FDA (regarding Par’s prior interactions with the FDA) and Dr. Jeffrey Kelman, Chief Medical Officer for the Center for Drug and Health Plan Choice at the Centers for Medicare and Medicaid Services (“CMS”) — who Par asserts has previously stated that Megace-ES is reimbursable for geriatric and cancer wasting. The Government, which opposes any discovery (for obvious reasons), must respond to Par’s motion by March 2nd.
The Government has predicated its motion to dismiss and for summary judgment on Par’s lack of standing, which in turn, is based on the remarkable statement in Dr. Sherman’s Declaration that “FDA does not consider a manufacturer’s truthful and non-misleading speech to healthcare professionals concerning the approved use of an FDA-approved drug as establishing, by itself, a manufacturer’s objective intent that the drug be used for an unapproved use” (emphasis added). Given the importance of Dr. Sherman’s Declaration to the Government’s motion, and given that this and similar sweeping statements in her Declaration repeatedly contain the “by itself” caveat — leaving Par and the rest of us to wonder “what else” besides on-label speech provides the Government with evidence of off-label intent — I think it highly unlikely that the Government will succeed in convincing the Court that it should dismiss Par’s complaint without the benefit of at least allowing for the deposition of Dr. Sherman. But let’s see what the Government says on March 2nd; maybe they’ll surprise us.