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Harvard Pilgrim awarded FDA contract for drug monitoring

WASHINGTON — The Food and Drug Administration, in an attempt to ensure the safety of popular medicines, is partnering with one of the most prominent medical insurers in Massachusetts.

It has awarded a contract for up to $150 million to Harvard Pilgrim Health Care Institute — a collaboration between Harvard Pilgrim Health Care and Harvard Medical School — to spearhead a program that sifts through billions of prescriptions and other electronic health care data to investigate issues with FDA-approved drugs.

Harvard Pilgrim will work with about 50 organizations, including hospitals and health insurance companies such as Aetna, to obtain information used in the analysis. Known as Sentinel System, the program builds on a five-year pilot project overseen by the institute.


This is about “recognizing risks that haven’t been identified before,” said Richard Platt, executive director of the institute.

The data, he said, link information on the drug to people who are using it. This helps doctors recognize a blood pressure medicine that might not work for a 65-year-old man, for example, or types of drugs that are causing pains for pregnant women. While organizations are increasingly harnessing data to understand societal problems, this marks the first such venture of its kind, Platt said.

An FDA spokeswoman said the agency plans to meet with Harvard Pilgrim to begin transitioning from the pilot program, known as Mini-Sentinel, to a fully functional system. FDA officials launched the monitoring initiative in 2008, amid an uproar over the agency’s failure to ensure the safety of the drugs it approved.

This focuses on drugs or medical products on the market. It does not handle specific patient records.

“It’s important to know this very valuable information is gleaned without tons of private information getting sloshed around,” Platt said.

The group already is assessing influenza vaccines and two blood thinners.


“This will improve the FDA’s capability to understand the safety of medicines that are in common use,” Platt said.

Jessica Meyers can be reached at jessica.meyers@globe.com.