TheHill.com - FDA to use Medicare data to sniff out drug side effects

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FDA to use Medicare data to sniff out drug side effects

By Young

Posted: 05/22/08 05:56 PM [ET]

The Bush administration announced a major new initiative Thursday that would

give the Food and Drug Administration (FDA) unprecedented access to

information on drug side effects from Medicare's massive prescription

database.

The so-called Sentinel System is designed to enable the FDA to detect

unexpected side effects from FDA-approved prescription drugs much more

quickly and accurately than ever before, Bush administration officials said.

" It will be a quantum leap forward in FDA's capacity to monitor the use of

medical products that are currently on the market, " Health and Human

Services Secretary Mike Leavitt said at a press conference. " The result will

be much improved safety and protection for the American people. "

In 30 days, the FDA will have access for the first time to Medicare claims

data housed at the Centers for Medicare and Medicaid Services (CMS). The FDA

will be able to use these data to determine links between drugs and side

effects, also called " adverse events. "

The FDA will be able to investigate whether a specific drug is associated

with a specific side effect among a much greater number of patients than

under the current, voluntary side effects reporting system, which will

remain in place.

Snip

For now, the FDA will have access only to Medicare data. As the program is

implemented, the agency will be able to tap into information from other

federal agencies, such as the Department of Veterans Affairs and the

Department of Defense, and from private health insurance companies. As

electronic prescriptions and electronic medical records proliferate, the

available information will grow further, Leavitt said.

This information will provide the FDA with a wealth of data on what drugs

are being prescribed and what medical conditions those patients have. FDA

officials can analyze that information to determine whether a side effect is

associated with a medicine. The information contained in the databases is

stripped of anything that could identify the patients, the administration

officials stressed.

The FDA must approve all drugs before they can be prescribed based on

clinical trials conducted by researchers. Although those trials test

medicines on thousands of people, a full understanding of drugs' side

effects cannot be achieved until many more thousands or millions of people

are using the medicine on a regular basis in the marketplace.

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Kathy