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Article Summary: Raw data pertaining to follow up investigations for seven deaths associated with Meridia
Meridia Pharmaceutical Drug Investigation
From January 7 through January 28, 2002, and March 21 through April 3, 2002, investigators from the Food and Drug Administration’s (FDA) Chicago District office conducted inspections of your firm located at the above address. The purpose of these inspections was to determine your firm’s compliance with the postmarketing adverse drug experience reporting requirements of Section 505(k) of the Federal Food, Drug, and Cosmetic Act ("the Act") and Title 21, Code of Federal Regulation (CFR), Part 314.80.
Based on our review of the inspection reports and reports submitted by your firm to FDA, we conclude that your firm failed to comply with Section 505(k)(1) of the Act and 21 CFR 314.80. Section 505(k)(1) requires an applicant to establish and maintain records, and report data relating to clinical experience and other data or information for drugs for which au approval of an application tied under 505(b) or 505(i) is in effect. Deviations from the 21 CFR 314.80 include the following:
Again, in violation of 21 CFR 314.80(c)(1)(i), your firm failed to submit to FDA within 15 days of your firm’s receipt of the information a serious and report for a death associated with the drug product, Meridia. [redacted] reported to you on November 20, 2000, but your firm did not report this serious and unexpected adverse event to FDA.
In further violation of 21 CFR 314.80(c)(1)(i), you submitted adverse drug experience information in reports to FDA which was inaccurate in some cases, or did not completely reflect information available in the source documents, such as in three reports of death associated with the use of Meridia.
Finally, in violation of 21 CPR 314.80(i), your firm did not always maintain records of raw data and correspondence related to adverse drug experiences. Raw data pertaining to follow-up investigations for seven deaths associated with Meridia [redacted] and [redacted] were not maintained and available for review. During the inspection, there was no case file for [redacted] and the case file for [redacted] did not contain any phone records or investigation records from the initial of May 12,1998 until March 22,1999. Your response letter set April 30, 2002, as your target date for gaining access to the records. Please let us know if this has been completed.
If you or anyone you know has taken Meridia and has experienced any negative symptoms or side-effects, please contact our expert lawyers and obtain a case evaluation at no cost to you..
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