The Food and Drug Administration is threatening to fine Acceleron Pharma (XLRN) for failing to submit required information about a clinical trial to a federal registry, the first time the agency has taken such a step in response to ongoing calls for greater transparency into clinical studies.
In an April 27 letter sent to the drug maker, the FDA noted the results of a Phase 2 clinical trial that was run to test a pair of drugs for treating advanced kidney cancer had not been posted, even though the agency contacted the company last July about the issue. Acceleron now has until May 27 to post the data and an Acceleron spokesman wrote us that the company plans to do so.
“Being transparent about the results of completed clinical trials enables important advances in the development of medical products and helps ensure a safe, effective and efficient clinical research enterprise,” Acting FDA Commissioner Janet Woodcock said in a statement.
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