Grassley asks drug makers what they told the FDA about anti-depressants and suicide among young people
WASHINGTON — Sen. Chuck Grassley has asked eight major pharmaceutical drugmakers to describe the kind of information they provided to the Food and Drug Administrationduring the government's review of the safety of pediatric use of anti-depressants. Last year, theFood and Drug Administration asked these manufacturers for pediatric trial data regarding theirantidepressant drugs.
Grassley made his request of the drug companies as part of his ongoing investigation into whether or not safety information was withheld from the public by the Food and Drug Administration. Today's letter asks questions to determine if the drug companies withheld anysafety information from the Food and Drug Administration about their antidepressant drugs. Thetext of the letter he sent to Pfizer, Inc., Wyeth Pharmaceuticals, GlaxoSmithKline, Bristol-MyersSquibb Company, Organon Pharmaceuticals USA Inc., Solvay Pharmaceuticals Inc., Eli Lilly & Company, and Forest Pharmaceuticals, Inc. follows here.
August 3, 2004
Several months ago, I initiated an investigation into the decision by the Food and DrugAdministration (FDA) to remove Dr. Andy Mosholder from the agenda for an FDA AdvisoryCommittee Meeting (ACM) that was scheduled on February 2, 2004. A number of additionalmatters have come to light since my Committee staff began its investigation, which requireclarification and information from your company.
In June 2003, Dr. Mosholder was charged by the Office of New Drugs (OND) at the FDAto conduct an analysis of the data from clinical trials of selective serotonin reuptake inhibitors(SSRIs) and other antidepressant drug products in pediatric patients. Dr. Mosholder's analysisconcluded that a "link" existed between the use of antidepressants by children and suicidalbehavior. However, the FDA did not allow him to present his analysis at the ACM.In preparing his analysis, Dr. Mosholder relied, in part, upon clinical trial data yourcompany provided to the FDA about your company's drug, ______. Additionally, FDA officialscontracted last fall with Columbia University (Columbia) to re-examine and classify data fromthe pediatric depression trials. It is my understanding that this study was led by a team of threeColumbia research scientists, who convened a panel of 10 independent members to review thedata. The Columbia study reportedly applied standardized terminology for suicidal acts andbehavior to over 400 case descriptions from the 25 pediatric antidepressant trials. Theseindependent reviewers, as I understand it, reviewed descriptions that your company, amongothers, used in reporting adverse events that occurred in its studies.
Hopefully, the Columbia study will add another important piece of the puzzle that willlead to a better understanding of the effects of antidepressant use among children andadolescents. It is essential, however, to ensure that all available information on pediatricantidepressant trials has been made available to the FDA. The Columbia Study and Dr.Mosholder's expert analysis are undoubtedly of interest to millions of parents whose children areusing antidepressants throughout the United States. My position is, and continues to be, thatdoctors and patients need to be given the fullest picture possible - they deserve to know more, notless - about the effectiveness of drugs.
In recent news reports, I have seen that some drug manufacturers of antidepressant arebeing accused of concealing important information about the safety and efficacy ofantidepressants. Specifically, it has been reported that some drug manufacturers have allegedlywithheld negative information and misrepresented data concerning the safety and efficacy ofantidepressants when prescribed for depression in children and adolescents.
I am concerned that some drug companies may not have provided the FDA with allinformation at their disposal. In light of these concerns, please respond to the following requestsfor information:
1. From January 1, 1990 through July 23, 2004, provide a list of all clinical trials and/orstudies initiated by your company relating to the pediatric use of antidepressants. Please identifyeach trial/study by name and provide a summary of the results of the study. This requestencompasses any trial/study -- including, but not limited to all randomized placebo-controlledtrials, open trials, and active-controlled trials -- conducted by your company relating to any NewDrug Application (NDA), Investigational New Drug (IND) application, or for any other reason.In addition, provide the following information with respect to each trial/study:
1a. State the date it was initiated and the date it was completed. If it was not completed,state in detail why it was not completed, who made the decision not to complete it, and at whatpoint it was terminated.
1b. State when and where it was published. If it was not published, state in detail why itwas not published.
2. State when and for what purpose the trial/study was submitted to the FDA. If it was notsubmitted, state in detail why it was not submitted.
OTHER DRUG STUDIES
1. From January 1, 2000 through December 31, 2003, provide a list of all INDs and NDAssubmitted by your company to the FDA. Please provide a brief summary for each IND andNDA.
2. From January 1, 2000 through December 31, 2003, provide a list of all clinical trialsand/or studies initiated by your company relating to the INDs and NDAs identified in Question 1.Please identify each trial/study by name and provide a summary of the results of the study. Thisrequest encompasses any trial/study -- including, but not limited to all randomizedplacebo-controlled trials, open trials, and active-controlled trials -- conducted by your companyrelating to any NDA, INDs, or for any other reason. In addition, provide the followinginformation with respect to each trial/study:
2a. State the date it was initiated and the date it was completed. If it was not completed,state in detail why it was not completed, who made the decision not to complete it, and at whatpoint it was terminated.
2b. State when and where it was published. If it was not published, state in detail why itwas not published.
3. State when and for what purpose the trial/study was submitted to the FDA. If it was notsubmitted, state in detail why it was not submitted.
Please provide the information requested by August 27, 2004, unless it is availablesooner. In addition, please provide the name and contact information of a person who will act asyour company's point of contact by August 11, 2004. In complying with this request, respond byrepeating the enumerated request, followed by the accompanying response. In the event thatdocuments or other materials are responsive, please be sure to mark them accordingly. Finally,in complying with this request, _______ means its corporation, or one or more of its divisions,subsidiaries or affiliates, or related entities, including any other companies or corporations withwhich ______ entered into a partnership, joint venture or any other business agreement orarrangement. Also, the terms "relating," "relate," or "regarding" as to any given subject meansanything that discusses, concerns, reflects, constitutes, contains, embodies, identifies, deals with,or is any manner whatsoever pertinent to that subject.
Any questions or concerns should be directed to our Committee staff, Emilia DiSanto orMichelle Anderson at (202) 224-4515. All correspondence should be sent via facsimile to (202)228-2131 and original by U.S. mail. All document deliveries should be coordinated with theChief Clerk for the Committee, Ms. Carla Martin, at (202) 224-4992, and delivered inaccordance with her instructions. In order to comply with Committee deadlines, certain deliveryinformation must be submitted to the Chief Clerk at least 24 hours ahead of the anticipateddelivery day.
Charles E. Grassley
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