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Regulatory Focus™ > News Articles > FDA to Spend $16M to Track National Prescribing Trends

FDA to Spend $16M to Track National Prescribing Trends

Posted 24 September 2014 | By Alexander Gaffney, RAC

FDA to Spend $16M to Track National Prescribing Trends

The US Food and Drug Administration (FDA) is preparing to put more than $16 million into a multi-year program intended to provide regulators with data on how US patients are prescribed drug products.

The data, including medical claims data, is meant to provide regulators with the ability to see which drugs are being used by patients, for how long and with what other drugs. Regulators are also looking to pair that data up with basic demographic data on patients, such as age and sex data. Patient-identifying data is not being sought, FDA said.

In an announcement on 23 September 2014, FDA's Center for Drug Evaluation and Research (CDER) said a contract worth $16,289,189 had been awarded to Source Healthcare Analytics Inc., a Phoenix, AZ-based subsidiary of Symphony Health Solutions.

The company offers a range of analytical services, including sales data on drug products, that FDA evidently hopes to leverage to answer its questions. FDA said it's interested in looking at "national patterns of drug utilization in the outpatient setting … for the purpose of conducting epidemiological drug safety studies."

In the past, FDA's Office of Surveillance and Epidemiology has used this data to highlight the growing utilization of opioids—data which has then been used to shape FDA policy.

Wolters Kluwer Health, the previous owner of Source Healthcare Analytics, has previously done business with FDA under an earlier iteration of the same contract.


FDA Award Notice

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