Celgene To The FDA: Oh… That White Paper
January 26th, 2012 // 2:00 pm @ jmpickett
You can get all sorts of things when you pay $2.9 billion for a biotech, including an admonition from the FDA. That’s what happened to Celgene last month, when the FDA issued a stern letter for a troublesome white paper that Abraxis BioScience had distributed at the American Society of Clinical Oncology meeting nearly two years ago.
The subject of the white paper was Abraxene, an injectable med used to treat metastatic breast cancer and a key reason that Celgene bought the biotech in late 2010. However, the paper broadened the indication for Abraxane, made unsubstantiated effectiveness and superiority claims, and omitted and minimized important risk information associated with its use. As a result, misbranding occurred.
There were other problems. For one, the paper promoted Abraxane as safe and effective for additional uses for which it is being studied. The paper was disseminated at ASCO without the full FDA-approved product labeling. And Abraxis failed to submit the paper in advance for FDA review. And if you were wondering how the FDA knew, well, a staffer grabbed a copy from the Abraxis booth in the exhibit hall.
This caused another big problem. Why? In November 2010, after Abraxis was purchased, Celgene responded to an FDA query asking about the paper, which was published in Drug Delivery Report. The drugmaker indicated the publication is not peer-reviewed, but the paper was restricted to individual requests by people with “clear business interests†in similar products or third-party relationships.
Here’s the kicker: The FDA maintains that Celgene “alleges that the white paper was not made available to the conference’s primary audience (physicians or others involved in the decision process for treating patients) or to the commercial sales force.†But the FDA staffer found the paper on the countertop at the Abraxis booth during exhibit hours, where anyone could get a copy.
The representative from the FDA Office of Prescription Drug Promotion “was neither approached by an Abraxis representative when the white paper was obtained nor was a PL (product labeling) offered or attached to the piece,†the FDA office writes to Celgene in a December 23, 2011, letter.
In other words, someone got their facts wrong… at best. The lesson? Next time a drugmaker wants to distribute an off-the-reservation white paper, it should not be left in plain view at a medical conference where FDA staff are snooping. Or just refrain from distributing a paper at all until the agency has given its blessing. One more thing: get your story straight before talking to the FDA.
