The FDA needs to do a better job of tracking drugmakers’ voluntary postmarketing studies, a new report issued by the Office of Inspector General (OIG) at the Department of Health and Human Services (HHS) found.
The report suggests the agency bolster its tracking methods and asks manufacturers to provide better information.
“FDA reviewers indicated to us that monitoring postmarketing study commitments is not generally considered a top priority at FDA . . .” (the agency) “lacks an effective management information system for monitoring postmarketing study commitments,” the report stated.
OIG reviewed FDA’s database of postmarketing study commitments for new drug applications approved during fiscal years 1990 through 2004, along with other related documents and information. OIG said that 35% of 336 annual reports due in 2004 “were missing entirely or contained no information on open postmarketing study commitments.”
The FDA disagreed that it “cannot readily identify whether and how timely postmarketing study commitments are progressing toward completion,” the report said. However, the FDA did agree to improve the management information system for monitoring postmarketing study commitments and to ensure that postmarketing study commitments are being monitored and annual reports are being validated, in a response included in the report. The agency highlighted ongoing efforts to enhance its postmarketing study commitment database and reporting capabilities, train its review division staff on annual report validation procedures, and standardize the process by which postmarketing study commitments are requested and reviewed.