Makers of approved drugsand biologics generally are meeting their regulatory obligations and completetheir postmarketing studies in a timely manner, according to a study releasedtoday by the U.S. Food and Drug Administration. A review of 1531 openpostmarketing studies indicated that over 80 percent are proceeding accordingto the established timelines, have been submitted for FDA review, or have beendetermined by the FDA to have met their goals or are no longer needed. The study, done under a contract with Booz Allen Hamilton and supported byadditional funds from Congress, examined the backlog of industry postmarketingstudies for FDA-approved drugs and biologics. The review found that mostcompanies meet their obligations in a timely manner. The study also recommended changes designed to improve the quality of theinformation submitted to the FDA, the timeliness of the FDA review, and theaccuracy of the FDA’s databases. The agency is evaluating the recommendationsand already has made significant improvements based upon the study: — Establishment of a postmarketing study development coordinator and atracking coordinator within each new drug division. — Development of new Manuals of Policies and Procedures (MAPP) fordevelopment of postmarketing studies and tracking the status ofpostmarketing studies. — Creation of a new postmarketing study database in the DocumentArchiving and Records Retention System (DARRTS) that includesincreased capabilities for data capture, tracking, and generatingreports related to postmarketing studies. This system was implementedthe end of July 2009. “New resources and directives from Congress have allowed us to completethis long-desired review,” said Janet Woodcock, M.D., director of the FDA’sCenter for Drug Evaluation and Research. “The data indicate that makers ofapproved drugs and biologics are generally meeting their regulatoryobligations and are on track with their studies. To date, we have notidentified any previously unknown serious safety issues from the submittedfinal study reports.” Under the Food and Drug Administration Amendments Act of 2007, the FDAmust undertake such a review annually. The review showed that the industry hasbeen initiating most studies on time and submitting final reports for manystudies, as required. Many of these reports are pending completion of athorough FDA review. The FDA will continue to work with Booz Allen Hamilton tocomplete the agency’s review of all submitted reports in a timely manner.Manufacturers of drugs and biologics are also required to report to theFDA in a timely manner any serious safety issues that are identified fromstudies or other sources.
