"In an unusual tactic, an attorney is prodding the FDA to seek documents that purportedly detail side effects caused by the Risperdal antipsychotic, but cannot be released publicly due to a court order. The documents were sealed by a Philadelphia judge as part of ongoing litigation over claims the Johnson & Johnson drug causes gynecomastia, which is the abnormal development of breasts in males (back story).
For the past year, Stephen Sheller has attempted to convince the FDA that the documents should be disclosed and, initially, filed a Citizen’s Petition, which also asks the agency to require a so-called Black Box warning to reflect what he has termed a lack of safety data. An FDA spokeswoman tells us the agency is “actively reviewing” the petition, but declined to comment further.
At issue is a deposition by former FDA commissioner David Kessler, who last fall submitted a 92-page report submitted as part of the litigation and slammed J&J for allegedly promoting Risperdal for unapproved uses (back story). His report - which is publicly available in four parts and can be read here, here, here and here - also refers to other documentation that is under protective order, according to Sheller."
“The FDA has to request that information from J&J (JNJ) and has the authority to do so,” says Sheller, who has spearheaded the litigation against the health care giant. “Without that information, they are not doing their job. It would be like an ostrich putting its head in the sand, because we’ve told them it’s there. J&J says they provided documents, but it’s a data dump. The FDA doesn’t know what to look for.”
Uh huh. "The FDA doesn't know what to look for."
And Good Luck to those FDA-ers, . . . . in finding whatever it is they don't know what to look for.