FDA slow to ask J&J for drug data, lawyer says

Tablets of the generic antipsychotic drug Risperidone, used to treat schizophrenia.
Tablets of the generic antipsychotic drug Risperidone, used to treat schizophrenia. (Bloomberg)
Posted: July 11, 2013

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.

"The FDA has the authority to demand safety-related documents in order to review them," Sheller wrote to Janet Woodcock, FDA director of drug evaluation and research. "The J&J information is already available to the FDA - all you have to do is ask them for the documents."

Based in New Brunswick, N.J., with operations around Philadelphia, J&J sells Risperdal through its Janssen subsidiary. Legal battles over antipsychotic medicine have been waged in federal, state, and local courts for much of the last decade. Company spokeswoman Teresa Mueller said again Tuesday that the drugs are safe and effective.

The FDA may have listened to Sheller, in a way.

"After the filing of Mr. Sheller's citizen petition, FDA asked the company to submit all available data regarding use of these medicines in children and adolescents as required by the applicable federal regulations," Mueller said in a statement. "Janssen submitted a formal response to this request and confirmed that we have provided all of the available data requested concerning these products."

FDA spokeswoman Sandy Walsh said the FDA was "actively reviewing" Sheller's citizen petition, but declined to answer questions because the decision was pending. She also declined to confirm that J&J had complied with the FDA's requests.

Sheller, who has a financial stake in the situation, had urged the FDA to release anything new it obtained from J&J or let his firm compare it with what J&J was required to disclose in litigation.

"No legitimate purpose would be served by declassifying the documents identified by plaintiffs," J&J's lead attorney Ken Murphy, of Drinker Biddle & Reath, wrote in his 2011 request to Philadelphia Common Pleas Court Judge Sandra Moss that Sheller be prevented from releasing documents to the FDA and the public.

"Plaintiffs' counsel has expressed intent and desire to provide various of these documents to the press" and advised the judge that he "may petition the Food and Drug Administration to revoke various approvals for Risperdal use in children and adolescents," Murphy wrote.

Moss agreed.


Contact David Sell at 215-854-4506, dsell@phillynews.com, or @phillypharma. Read his blog at www.inquirer.com/phillypharma.

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