FDA Report Shows Firms Drag Feet on Postmarket Study Commitments

摘要

Although drugmakers may rush to get products approved, a new report finds they are dragging their feet when it comes to meeting post-market study commitments. Sixty-two percent of postmarket studies promised by drug and biologies makers had not begun as of Sept. 30, 2007, according to an FDA study scheduled to be published in Thursday's Federal Register. Companies with open postmarketing commitments for BLAs did not submit annual reports for 51 percent of the applications by the required date, and companies with NDAs and AND As did not submit 37 percent of their reports on time. Once a postmarketing study commitment is made, an applicant must report the progress on the anniversary of the product's approval until the study commitment is completed or terminated. The FDA requires reports on the status of each clinical safety, clinical efficacy, clinical pharmacology and nonclinical toxicology study. An annual progress report must include a description of the postmarketing study commitment, a schedule for completing the study and a characterization of the study's current status. The report also must briefly describe the study commitment's progress.