Wednesday, December 31, 2008

Off-label promotion of drugs not inherently misleading

In re Epogen & Aranesp Off-Label Marketing & Sales Practices Litigation, --- F. Supp. 2d ----, 2008 WL 5335062 (C.D. Cal.)

The plaintiffs mostly provide health care benefits to various union workers and dependents, though one is a private third-party payor. They proposed to represent a class of everyone who paid any part of the purchase price of Epogen and Aranesp when prescribed for off-label use. These drugs simulate the production of red blood cells and are approved for treating anemia in certain patients with other serious medical problems.

Defendants are Amgen, a large pharmaco, and two providers of dialysis services. From 2002 until at least 2007, Amgen issued press releases touting clinical studies on off-label uses of Aranesp, but didn’t disclose that the studies were Amgen-funded. Amgen also funded third-party groups that pushed off-label uses of Aranesp to doctors through continuing medical education and other means, allegedly concealing or minimizing evidence of the drugs’ risks (heart attacks, strokes, tumor growth, and death). Amgen entered into supply contracts with the other defendants providing volume-based discounts and other incentives for increased IV use of the drugs. In early 2007, the FDA mandated a “black box” warning about off-label use of Aranesp, based on studies showing that its use shortened the time to tumor progression and increased the risk of death in certain classes of cancer patients.

The court dismissed plaintiffs’ RICO claims as being fundamentally based on the idea that merely promoting the drugs for off-label use was unlawful. This amounted to an attempt to enforce the FDCA, but the FDCA does not provide for a private cause of action. Similarly, the state-law false advertising/unfair competition claims were basically premised on the idea that off-label promotion was unlawful and therefore unfair and inherently fraudulent. Precedent holds that, in itself, off-label promotion is not inherently misleading. However, false advertising laws can be used to fight false pharmaceutical advertising even though there is overlap with FDA jurisdiction. FDA label regulations are designed to support the FDA’s authority to approve new drugs; without regulation of off-label promotion, there would be no incentive for companies to get approval for new uses. Thus, consumer protection objectives diverge from the more arbitrage-focused FDA regulations, and consumer protection laws have a separate role to play in regulating drug ads.

Some of plaintiffs’ claims--e.g., that defendants promoted the false belief that the drugs were safe for off-label uses at excessive doses and that they concealed adverse study results and selectively disclosed positive studies—could be repled as pure fraud/false advertising claims. The FDA lacks special expertise on whether the claims were likely to mislead or deceive the recipients of the ads. Thus, the plaintiffs were allowed leave to amend the complaint to allege specific misrepresentations, subject to the requirements of Rule 9(b) (note that this is a heavy burden; not all courts require false advertising claims to be pled with particularity, because fraudulent intent is not an element of most false advertising laws).

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