Par Pharmaceutical has filed suit against the Food and Drug Administration, claiming that FDA regulations violate its First Amendment right to provide physicians with information about the on-label use of its appetite stimulant Megace ES.
The FDA approved megestrol acetate, marketed as Megace ES, in 2005 for the treatment of anorexia, cachexia, or an unexplained significant weight loss in AIDS patients. Par noted that 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," the firm said in its announcement of the suit.
In an Oct. 14 news release, Par said it "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."
The complaint, filed in the U.S. District Court for the District of Columbia, seeks a declaratory judgment and preliminary injunction.
The concern presumably centers on Par promoting or detailing the product to physicians that do not primarily treat HIV patients, although the firm did not specify.
"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," the company said.
Allergan made similar claims in a suit it filed against the FDA in October 2009. It challenged the FDA’s prohibitions on what it could tell physicians about unapproved uses of Botox (onabotulinumtoxinA). Allergan dropped the complaint last year as part of its settlement with the Department of Justice over its off-label marketing of the drug.
There is a chance Par’s suit could be similarly derailed. The Department of Justice is investigating Par’s promotional practices in sales and marketing of Megace ES. The company received a subpoena from the government for documents relating to Megace ES marketing in 2009. Any settlement is likely to require Par to drop its complaint against the FDA.
Allergan had proposed prohibiting promotion of uses for which a company was not seeking approval or having companies disclose that a use is unapproved. But, in a court filing, the FDA said it would not be possible to narrowly define promotion as companies are constantly developing new ways to convey messages about their products, in part to avoid detection by the agency.
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