The Food and Drug Administration (FDA) does not have a reliable, easily accessible on the issues of security studies and post marketing of drugs approved by the expedited review of routes, said the Government Accountability Office in a report published on Thursday.
The report has dug in the FDA Center for Drug Evaluation and Data Research (CDER), which received nearly 1,000 applications for the designation of the highway and advanced designation therapy (the other two accelerated programs for review new drug approval and review of priority) are accelerated and were mostly of cancer drugs.
Among more than 770 quick applications runway designation since fiscal year 2007, the FDA granted approximately two thirds of these applications, and over 220 requests for appointments advanced therapy since this route was established in July 2012 agency denied more than half of these requests.
However, the GAO found that assessments made by the CDER data to monitor security events have revealed problems with the integrity, timeliness and accuracy of the data.
Specifically, the GAO said CDER indicated that a large number of potential security problems were not registered in its database, known as document archiving, reporting and monitoring of Regulations (DARRTS). Among the probable meetings criteria for security issues tracked CDER has identified 144 issues that were not formally followed DARRTS.
In addition, GAO found that more than half of the opinions on the observations sponsors associated with about 1,400 post-marketing studies FDA requested or required March 2008 to September 2013 will be delayed or late.
"These problems as well as problems with the way data is recorded that impede accessibility, prevented the FDA published reports required by law in some potential safety issues, and post-marketing studies on time timely, and limits the ability of the agency to conduct post-marketing drug safety monitoring systematically, "Gao said.
The Office found that the FDA does not intend to use these data to inform their monitoring of its accelerated programs, for example, if drugs that use a then accelerated program were associated with problems security followed in levels or types that are approved drugs differ from Standard Lead FDA.
In October 2015, the FDA had not issued the required annual reports with data on post-marketing studies for 2013 and 2014.
"FDA officials said they had decided to delay the publication of reports is mainly due to the internal evaluation of CDER post-marketing data and subsequent to solve data problems have been identified efforts to study," said the report.
Rep. Rosa DeLauro (D-CT), which commissioned the GAO report, said in a statement on Thursday: "The GAO report confirms my worst fear, that the FDA does not have the basic resources and leadership, ensuring that drugs are brought to market quickly really safe and effective. "
In its defense, the FDA said it would like to clarify three issues related to a draft report.
First, the agency says that all drugs must meet the same regulatory standards for safety and effectiveness, regardless of their accelerated state. Second, medicines authorized via accelerated not necessarily require different postmarketing other drugs approved by conventional means studies and, finally, the FDA says it is working to address "the challenges of administrative supervision his work in the post-market safety. "
The report has dug in the FDA Center for Drug Evaluation and Data Research (CDER), which received nearly 1,000 applications for the designation of the highway and advanced designation therapy (the other two accelerated programs for review new drug approval and review of priority) are accelerated and were mostly of cancer drugs.
Among more than 770 quick applications runway designation since fiscal year 2007, the FDA granted approximately two thirds of these applications, and over 220 requests for appointments advanced therapy since this route was established in July 2012 agency denied more than half of these requests.
However, the GAO found that assessments made by the CDER data to monitor security events have revealed problems with the integrity, timeliness and accuracy of the data.
Specifically, the GAO said CDER indicated that a large number of potential security problems were not registered in its database, known as document archiving, reporting and monitoring of Regulations (DARRTS). Among the probable meetings criteria for security issues tracked CDER has identified 144 issues that were not formally followed DARRTS.
In addition, GAO found that more than half of the opinions on the observations sponsors associated with about 1,400 post-marketing studies FDA requested or required March 2008 to September 2013 will be delayed or late.
"These problems as well as problems with the way data is recorded that impede accessibility, prevented the FDA published reports required by law in some potential safety issues, and post-marketing studies on time timely, and limits the ability of the agency to conduct post-marketing drug safety monitoring systematically, "Gao said.
The Office found that the FDA does not intend to use these data to inform their monitoring of its accelerated programs, for example, if drugs that use a then accelerated program were associated with problems security followed in levels or types that are approved drugs differ from Standard Lead FDA.
In October 2015, the FDA had not issued the required annual reports with data on post-marketing studies for 2013 and 2014.
"FDA officials said they had decided to delay the publication of reports is mainly due to the internal evaluation of CDER post-marketing data and subsequent to solve data problems have been identified efforts to study," said the report.
Rep. Rosa DeLauro (D-CT), which commissioned the GAO report, said in a statement on Thursday: "The GAO report confirms my worst fear, that the FDA does not have the basic resources and leadership, ensuring that drugs are brought to market quickly really safe and effective. "
In its defense, the FDA said it would like to clarify three issues related to a draft report.
First, the agency says that all drugs must meet the same regulatory standards for safety and effectiveness, regardless of their accelerated state. Second, medicines authorized via accelerated not necessarily require different postmarketing other drugs approved by conventional means studies and, finally, the FDA says it is working to address "the challenges of administrative supervision his work in the post-market safety. "
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