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FDA is Slow to Ask Johnson & Johnson (JNJ) for Drug Data



7/10/2013 7:44:25 AM

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The U.S. Food and Drug Administration is dragging its feet in addressing concerns that Johnson & Johnson's antipsychotic drugs Risperdal and Invega are dangerous, a Philadelphia lawyer says in letters to the federal agency, and the company should allow those alleging harm from the medicines to release information provided by the company during lawsuits' discovery phase. Johnson & Johnson's attorneys persuaded a Philadelphia judge to seal some of the information that lawyer Stephen Sheller's firm obtained from the company. But knowing that the FDA cannot order judges to do anything, Sheller urged agency leaders in what is called a "citizen petition" in 2012, and then in a July 2 letter, to pressure the company to allow Sheller to give the information to the FDA or to demand the same information directly from J&J - either way, preferably, for public review.

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