Forest Labs To Establish Clinical Trials Registry
Attorney General Spitzer today announced an agreement with a second leading pharmaceutical company to resolve an inquiry into whether the company concealed information about the safety and effectiveness of certain drugs.
As part of the agreement, Forest Laboratories, Inc. will establish an online Clinical Trials Registry that will publicly disclose information on clinical studies of its drugs, upon initiation of each study and after its completion.
The agreement with Forest Labs comes two weeks after Spitzer's announcement that GlaxoSmithKline would create a similar registry in settlement of a lawsuit Spitzer filed in June alleging that the company withheld negative information about Paxil, a drug used to treat depression.
"I am pleased that Forest Labs has quickly followed the GlaxoSmithKline settlement by agreeing to release both positive and negative studies about the safety and efficacy of its drugs and that other leaders in the industry are following suit," Spitzer said. "As this settlement indicates, we remain committed to ensuring that doctors and patients have access to all scientifically sound information so doctors can prescribe appropriate medication for their patients."
In June 2004, the Attorney General sent a letter to Forest Labs requesting information relating to off-label uses of certain drugs, including the anti-depressants Lexapro and Celexa.
In the agreement, Forest Labs agrees to post online clinical studies on the use of Lexapro and Celexa in children and adolescents. In addition, Forest Labs will establish an online Clinical Trials Registry that will contain summaries of results for all Forest-sponsored clinical studies of drugs conducted after January 1, 2000 and any earlier studies that are relevant to the use of the drug and care of patients. Forest will also post information about studies when they are initiated, including the study start date and the study's key objectives.
The Clinical Trials Registry will present summaries of the results of clinical studies in a standardized format and with content that conforms to the requirements of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Each clinical study summary posted on the registry will contain over 20 categories of information.
The agreement also sets forth specific time periods during which Forest Labs will upload data into the Clinical Trials Registry. Forest Labs is required to post summaries of clinical studies completed prior to the date of the agreement by December 31, 2005. Summaries of clinical studies completed after the date of the agreement for drugs already approved and marketed will, in most cases, be posted to the site no later that twelve months after the study completion date. For drugs approved and marketed after the agreement date, summaries of the studies will, in most cases, be posted no later than 12 months after the drug is first marketed.
Spitzer commended Forest Labs officials for working with his office to resolve the matter.
In addition to Glaxo and Forest Labs, Eli Lilly and Merck have also recently announced that they will post clinical study information on their drugs.
The Forest Labs inquiry was handled by Assistant Attorneys General Rose Firestein and Shirley Stark, under the supervision of Thomas Conway, Chief of the Consumer Frauds and Protection Bureau, and Joseph Baker, Chief of the Health Care Bureau.
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