Government Prosecution For “On-Label” Discussions? Par Files Suit to Stop Government From Expanding Its Reach

By Anne K. Walsh –

In what may be a game-changer for drug companies, a court in the District of Columbia has been asked to set forth parameters for a pharmaceutical company that markets its products in a way that the government may consider to be off-label promotion.  Par Pharmaceuticals recently challenged (here and here) FDA’s authority in the off-label promotion arena on First Amendment and Administrative Procedure Act grounds.  Specifically, Par’s action challenges the government’s theories that drugs promoted for unapproved uses are either unapproved “new drugs” based on the statutory definition contained in the Federal Food, Drug, and Cosmetic Act, or “misbranded” drugs, because the drug failed to bear adequate directions for use, sometimes called the “backdoor” new drug charge.   

Par very clearly and accurately describes in its court documents the problems associated with these legal theories, so they are not necessary to reiterate here.  In addition to those challenges, what is unique about Par’s challenge is that it also seeks a declaratory judgment from the court that FDA cannot prosecute Par for making on-label statements about a drug’s approved uses.  Although this seems intuitively logical, Par’s case highlights the overbreadth of FDA’s “intended use” regulations and its authority to regulate speech. 

According to Par, the U.S. Attorney’s Office in the District of New Jersey subpoenaed documents relating to Par’s sales and marketing of its drug, Megace® ES.  Megace® ES is approved only for AIDS patients, to treat anorexia, cachexia or unexplained weight loss (also known as wasting) frequently associated with AIDS patients.  It is more frequently prescribed by physicians, however, for non-AIDS patients who experience wasting, such as cancer and geriatric patients.  Indeed the majority of its sales are to off-label populations.  

In the Complaint, Par details how it purposefully tailored its marketing strategy knowing that the drug was only approved for use by AIDS patients.  Par evaluated the market and decided to talk to doctors in oncology and long-term care settings, not to promote off-label for these patients, but to discuss the on-label treatment of AIDS patients who doctors serve in these settings.  Par determined that these doctors “reasonably may encounter patients suffering from AIDS-related wasting, and thus may have occasion to prescribe Megace® ES for its on-label use.”  Complaint, ¶ 50.  In discussions with Par, the government indicated that Par should have confirmed that there are a “sufficient” number of on-label patients being treated in those settings before Par called on them.  Id. ¶ 71.  Of course as Par correctly notes, there is no guidance provided by the government that defines what is a “sufficient number” to allow Par to have no fear of promoting on-label in those settings.

There are several factors that support a favorable ruling to Par in this action assuming the Court reaches the merits of the dispute.  First, there is practice-based evidence and scientific support of the drug’s efficacy in treating these off-label populations.  Second, there are several authoritative treatment guidelines recommending the off-label use of the drug, including from government agencies like CMS, a sister agency of FDA.  Third, the government determined that the off-label uses are “medically accepted” and reimburses for them from its federal healthcare programs.  Finally, the use of Megace® ES is virtually the standard of care for treating wasting, in AIDS, non-AIDS, geriatric, and oncology patients.  Indeed, this was one of the reasons why it was impossible for Par to develop an appropriate placebo-controlled clinical trial (typically necessary for FDA approval) – as doctors refused to use something other than Megace® ES on their patients.  

This action by Par is just another development in what industry hopes is a restriction on FDA’s authority to prohibit truthful, non-misleading speech.  In the last few months, we have seen the Supreme Court’s decision in IMS Health v. Sorrell, the Citizen Petition filed by the Medical Information Working Group asking FDA for clearer off-label regulations, and supplemental briefs filed in the pending Second Circuit appeal in United States v. Caronia (reported on here).  Because a victory by Par could result in a ruling that certain marketing conduct cannot be prosecuted, many in the industry eagerly await the outcome here.