U.S. government accountability Bureau believes that FDA has defects in the supervision of new drug approval

Source: Ding Xiangyuan 2016-01-18 US Government Accountability Office (GAO) recently released a report that, although FDA is committed to accelerating the review of new drugs, once the drugs are approved, the agency fails to fully track the safety issues related to these drugs In particular, Gao pointed out that "FDA lacks reliable and accessible data for tracking security issues and post market research, and post market research needs to meet some post market security reporting responsibilities and systematic supervision." According to the data of FDA, about 25% of new drug applications approved by FDA drug evaluation and research center between January 2006 and December 31, 2014 adopt at least one accelerated review procedure, Gao said in its report According to the report, although most of the applications only use one accelerated review procedure, some use two or more, of which all four accelerated review procedures are used for the marketing applications of two tumor drugs The Gao explained that although the FDA uses an internal database to potentially track major safety issues with these drugs, the evaluation conducted by the drug evaluation and Research Center found data integrity, timeliness and accuracy issues The report points out that these problems, together with recording problems that impair the accessibility of data, have prevented FDA from issuing required reports on potential safety issues in accordance with the provisions of the law and from systematically monitoring the safety of post marketing drugs The report further noted that the FDA did not use the data collected to guide plans to speed up the monitoring of review procedures, including determining whether there is a level or type of safety for drugs that are granted accelerated review, which is different from drugs that use standard review procedures Gao suggested that FDA should make a plan to correct the confirmed problems through post marketing safety data, so as to ensure that the data can be used for supervision Gao noted that the U.S Department of health and human services agreed with its recommendations and provided additional information on FDA's post market safety efforts According to a recent report, FDA approved 45 new drugs in 2015, the highest number in 19 years More than half of these drugs have been given some form of accelerated review.