Par Sues FDA To Get "Tailored" Rules On Off-Label Promotion

Par claims it is being blocked from informing physicians about the approved use of Megace ES; the case could be derailed by a DoJ complaint against Par, as was Allergan's suit against FDA.

Par Pharmaceutical Inc. is taking up the battle against FDA that Allergan Inc. withdrew from last year. The company filed suit against the agency claiming FDA regulations violate its First Amendment right to provide physicians with information about the on-label use of its appetite stimulant Megace ES (megestrol acetate).

In an Oct. 14 release Par said that through the suit 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.

FDA approved 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.

The concern presumably revolves around 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.

Par's Legal Troubles

Allergan made similar claims in a suit it filed against FDA in October 2009. It challenged 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 of its off-label marketing of the drug (Also see "Botox Reimbursement Training Is Driving Factor In Allergan Settlement With DOJ" - Pink Sheet, 1 Sep, 2010.).

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 FDA.

Par is facing a separate government complaint relating to an alleged switching scheme. The federal government and several states recently intervened in a whistleblower suit claiming that Par induced Walgreens and other pharmacies to fill prescriptions for capsule forms of generic Prozac (fluoxetine), Zantac (ranitidine) and other drugs with higher priced tablet formulations. The capsules were subject to Medicaid price limits so pharmacies got higher reimbursements from state Medicaid programs by making the switch to tablets.

Par had been subject to a separate qui tam suit alleging it set false and inflated prices for certain drugs covered by state Medicaid programs. In August the company agreed to pay $154 million to the federal government and five states to settle the average wholesale price inflation claims.

A Gathering Off-label Storm For FDA

FDA rejected the idea of creating tailored restrictions on off-label marketing practices when Allergan sued, but the legal landscape is now somewhat different for the agency.

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 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 .

Since Allergan agreed to drop its suit, though, several developments may be pushing off-label rulemaking away from FDA's traditional stance.

Most prominently, FDA's restrictions on off-label promotion have been questioned following IMS' successful challenge of a Vermont law limiting the sale of prescriber data (Also see "FDA Off-Label Regs Face Cave-In Risk After Supreme Court Data-Mining Ruling" - Pink Sheet, 4 Jul, 2011.).

That ruling could have its first downstream impact in the appeal of a case involving a former sales rep convicted of misbranding Jazz's (now Orphan's) narcolepsy drug Xyrem (sodium oxybate) because he discussed unapproved uses (Also see "Sales Rep's Free Speech Challenge Of Off-Label Regs Boosted By Sorrell Ruling" - Pink Sheet, 5 Sep, 2011.).

The agency is also being petitioned by a group of firms which includes Allergan to issue regulations on how sponsors can communicate with formulary committees and groups that set clinical practice guidelines (Also see "Paving New Regs: Firms Petition For Smoother Ride For Off-Label Communications" - Pink Sheet, 11 Jul, 2011.).

And while Par's statements emphasize that it wants to make on-label communications about Megace ES, the firm's suit is definitely a dynamic piece of the evolving off-label legal puzzle for FDA.

- Brenda Sandburg ([email protected])