WOODCLIFF LAKE, N.J., Oct. 14, 2011 /PRNewswire/ -- Par Pharmaceutical, Inc., the wholly-owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE: PRX ) today announced that it filed a declaratory judgment complaint and a motion for preliminary injunction in U.S. District Court in Washington, D.C. seeking to preserve Par's First Amendment right to provide truthful information to physicians and other healthcare providers about the FDA-approved, on-label use of Par's prescription drug, Megace® ES.
In 2005, the FDA approved Megace® ES for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients diagnosed with acquired immunodeficiency syndrome (AIDS). In addition to prescribing Megace® ES on-label to treat their AIDS patients, physicians frequently prescribe the drug off-label to treat wasting in non-AIDS, cancer, and geriatric patients. Certain FDA regulations nevertheless purport to ban Par from speaking about the approved use of Megace® ES to physicians who may prescribe the drug for unapproved uses. Par's preliminary injunction motion argues that those FDA regulations are contrary to both the First Amendment to the U.S. Constitution and the Federal Food, Drug, and Cosmetic Act. Par contends that the government's effort to minimize off-label use by means of banning Par's truthful speech is unjustified since off-label use is lawful, widespread, medically necessary and reimbursed by the federal government under the Medicare and Medicaid programs.
Through its suit, Par hopes to elicit tailored and constitutionally permissible regulatory guidance to ensure that physicians may be kept abreast of valuable, on-label information about prescription drugs to aid in their provision of quality and informed patient care.
Par is represented in its lawsuit by Arnold & Porter LLP in Washington, D.C.