FDA criticised for safety data flaws
pharmafile | January 18, 2016 | News story | Sales and Marketing | FDA, US Government Accountability Office, pharmacovigilance, post-marketing data, safety
The US FDA is failing to meet its ‘statutorily required’ obligations to track safety data for drugs post-marketing and publish quarterly reports of the monitoring data, a report by the US congressional watchdog has found.
Post-marketing safety data is crucial to uncover problems with drugs that may not have occurred during controlled clinical trials. But the US Government Accountability Office (GAO), an independent organisation that scrutinises Government agencies and how they perform the constitutional duties, says the Agency is failing in its responsibility to monitor the safety of drugs approved through its expedited programs.
GAO analysed FDA data on requests for fast track or breakthrough therapy designation and approved drug applications that used an expedited program from October 1, 2006, to December 31, 2014 (the most recent available).
According to Democrat senator Rosa DeLauro, who requested the investigation, the results ‘confirm my greatest fear.’
“FDA lacks fundamental resources and leadership in ensuring that drugs brought quickly to market are truly safe and effective,” DeLauro said in a statement. “If FDA is shifting more of the safety risk to consumers by allowing fewer and shorter clinical trials on expedited drugs, adequate tracking of drug safety issues and review of post market studies are absolutely vital.”
Biopharma companies have submitted more than 770 requests for fast track designation since the fiscal year 2007, and the FDA approved about two-thirds of these requests, and about half of the 220 requests for breakthrough therapy designation since this approval pathway was established in July 2012. About a quarter of the drug applications approved between October 1, 2006 and December 31, 2014, used at least one expedited program, with oncology drugs representing about one in five applications.
But the report says the agency is failing to maintain adequate standards in safety data monitoring after these drugs are approved. It highlighted serious concerns about the FDA’s data collection – including “problems with the completeness, timeliness, and accuracy of the data”, and failing to publish regular and legally required safety reports. It also says the Agency ‘lacks plans’ to rectify the problems uncovered by its investigation.
“[The] FDA lacks reliable, readily accessible data on safety issues and post-market studies needed to meet certain post-market safety reporting responsibilities and to conduct systematic oversight… [and] evaluations conducted by the Centre for Drug Evaluation and Research of data in its database revealed problems with the completeness, timeliness, and accuracy of the data.
“These problems, as well as problems with the way data are recorded that impair their accessibility, have prevented FDA from publishing statutorily required reports on certain potential safety issues and post-market studies in a timely manner, and have restricted the agency’s ability to perform systematic oversight of post-market drug safety.”
The GAO is unconvinced about the Agency’s ability to fix the problems, saying: “Although FDA has taken some steps to address the problems with its data, the agency lacks plans that comprehensively outline its efforts and establish related goals and time frames. Additionally, FDA does not have plans to use these data to inform its oversight of its expedited programs, such as determining if drugs that used an expedited program were subsequently associated with tracked safety issues at rates or of types that differed from drugs that used FDA’s standard process.” The GAO and ordered the FDA to work with the Department of Health and Human Services to put its processes in order.
In a statement, FDA spokesman Christopher Kelly said the FDA has already begun to retrospectively take action, adding: “Staff have prioritised the work of fully addressing and resolving important public health issues over completely adhering to the time-consuming data entry procedures of tracking safety issues.”
Lilian Anekwe
Related Content
GSK’s Jemperli accepted for FDA review for endometrial cancer treatment
GSK has announced that the US Food and Drug Administration (FDA) has accepted its supplemental …
FDA approves ImmunityBio’s Anktiva bladder cancer treatment
ImmunityBio has announced that the US Food and Drug Administration (FDA) has approved Anktiva (N-803, …
Roche’s Alecensa approved by FDA as lung cancer treatment
Roche has announced that the US Food and Drug Administration (FDA) has approved Alecensa (alectinib) …
