The FDA Bad Ad program, in which someone drops a dime on offending promotional materials, has turned up another violator. The latest is Three Rivers Pharmaceuticals, which is headed by former ImClone Systems ceo and convicted inside trader, Sam Waksal.

In a warning letter posted on the FDA web site, Sam & Co. are taken to task for a host of offenses in connection with a Statgram communication for the Infergen hepatitis c treatment - omitting and minimizing risk info; broadening the indication and omitting important facts; overstating efficiacy; making unsubstantiated claims, and failing to provide adequate directions for use. In short, Three Rivers did almost nothing right.

Topping the list: the Statgram claims docs can obtain additional prescribing info, including the safety profile and a boxed warning…regarding autoimmune, neuropsychiatric, ischemic and infectious disorders, and product info by visiting www.infergen.com. Why is this a problem? The FDA’s Tom Abrams, who heads the Division of Drug Marketing, Advertising and Communications, writes this:

“This statement represents the sole presentation in the piece of the significant and potentially fatal risks associated with Infergen. The other boxed warnings related to combination use with ribavirin, all contraindications to the use of Infergen and ribavirin, most warnings and precautions, and common adverse events are completely absent.”

“…Referring readers to the product website for safety information is insufficient to balance the efficacy claims in the piece. As a result, the Statgram misleadingly suggests that Infergen is much safer than has been demonstrated by substantial evidence or substantial clinical experience. Omitting information about serious and potentially fatal risks associated with Infergen’s use in combination with ribavirin raises serious public health and safety concerns.”

Abrams is also concerned because the Statgram overlooks some serious issues that healthcare providers ought to know. One example: the Statgram minimizes various risks by failing to note that “patients should be monitored closely with periodic clinical and laboratory evaluations” and that “patients with persistently severe or worsening symptoms of these conditions should be withdrawn from therapy.”

Another example: the Statgram cites underpowered open-label studies to make unwarrranted claims about sustained virologic responses. This contrasts with the FDA-approved prescribing info, prompting Abrams to ask Sam: “if you have evidence to support this claim, please submit it to FDA for review.”

There is more, which you can read here. The letter, by the way, contains the usual biolerplate closing: “The violations discussed in this letter do not necessarily constitute an exhaustive list.” In this instance, however, it would appear Sam & Co has already generated an impressive list of violations that serve as a roadmap for how not to promote a med. And this, just after scooping up Three Rivers. UPDATE: A spokesman for Three Rivers, which is owned by Kadmon Pharmaceuticals, writes us to say the Statgram was sent shortly before Three Rivers was purchased.