Regulatory Focus™ > News Articles > Regulators Again Look to Databases to Help Assess Safety of Adult, Pediatric Drugs

Regulators Again Look to Databases to Help Assess Safety of Adult, Pediatric Drugs

Posted 14 June 2013 | By Alexander Gaffney, RAC 

US regulators have issued a new call for proposals from private contractors in the hopes of being able to access data regarding the adults and pediatric utilization of drugs in inpatient and emergency settings in the hopes of conducting better postmarket surveillance on the safety of pharmaceutical and biopharmaceutical products.

Need for Safety Data

The proposal, first posted on 3 June 2013 and since updated with additional information, is a response to what the US Food and Drug Administration (FDA) identified as two primary factors: A 2005 report by the Institute of Medicine (IOM) that called for a modernized drug safety system built upon new databases, and the 2007 passage of the FDA Amendments Act (FDAAA), which permitted the agency to access disparate data sources to identify drug use trends on a national level.

Mindful of the IOM's 2005 report and empowered by FDAAA, FDA says it now wants to leverage its authority to better respond to the "increasing number of post-marketing issues" it now sees in order to protect public health.

And in this case, those data are set to come from inpatient and emergency department settings where FDA is interested in collecting use data on adult and pediatric patients as a way to provide context for adverse event reports, to model drug risk based on use patterns, and to calculate reported use rates for various drugs.

Focus on Pediatrics

"Access to these data also increase the FDA's ability to request regulatory impact studies such as those authorized under Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA) to better understand the usefulness of drug labeling to clinicians," FDA explained. The PREA and BPCA legislation are intended to incentivize and otherwise require companies to conduct pediatric testing on selected products to determine if they are safe for use in pediatric populations.  By examining actual use in hospitals, FDA says it will be better able to determine which drugs need additional studies conducted by assessing use relative to the labeling.

Data Being Sought

Among the data FDA says it is looking for are:

  • drug product usage and treatment procedures
  • discharge-level/patient-level data
  • age and gender data of patients

The new notice calls for $1.74 million in funding to be distributed to a contractor to build and maintain the database over three years, offering real-time access for FDA staff.

Bids are due by 26 June 2013.


FDA Request for Proposal Notice


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