Regulatory Focus™ > News Articles > Woodcock: Electronic Health Records Key To Helping Regulatory Professionals

Woodcock: Electronic Health Records Key To Helping Regulatory Professionals

Posted 22 March 2012 | By Alexander Gaffney, RAC 

Janet Woodcock, Director of the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER), told a pharmaceutical conference this week that electronic health records are key to allowing regulators to "learn more quickly of problems with medicines after they enter the market," reports The Philadelphia Inquirer.

Woodcock noted the numerous issues with the current system of prescribing and tracking pharmaceutical products and their adverse events, including poor prescribing methods, poor patient adherence, slipshod adverse event reporting and poor use of real-world data in current drug development.

All of this has a negative effect on consumer confidence in drug companies, concluded Woodcock.

"It really disappoints the public and results in spasms of hostility against the regulators, the drug-development community, and sometimes the medical community," said Woodcock.

Having a strong electronic health record system would help to alleviate or solve many of these problems, said Woodcock, by creating a more consistent, predictable and useful amount of data for regulatory professionals to use.

Read more:

Philadelphia Inquirer - FDA official sees hope in electronic health records

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