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FDA unveils plan to monitor drug safety

Federal health officials are getting new authority to mine prescription drug usage by millions of participants in the Medicare drug program to look for safety problems.
/ Source: The Associated Press

Federal health officials are getting new authority to mine prescription drug usage by millions of participants in the Medicare drug program to look for safety problems with medicines and medical devices after they hit the market.

The Food and Drug Administration has been under increasing pressure to develop a drug surveillance system since the painkiller Vioxx was pulled from the market in 2004 after it was linked to increased risk of stroke and heart attack.

New regulations unveiled Thursday by the Department of Health and Human Services will enable federal agencies, states and academic researchers to use Medicare claims data. Protections will be put into place to protect patient privacy and trade secrets.

Medicare beneficiaries use an average of 28 prescriptions a year, and those who consider themselves in poor health have an average of 45 prescriptions annually, giving health officials a huge database of health records to tap into.

Officials said they would no longer have to wait years to see how a drug or medical device affects millions of people.

"The era of wait and see is going to become the era of tell me right now," said the FDA commissioner, Dr. Andrew von Eschenbach.

The Institute of Medicine recommended creation of such a surveillance system in 2006.

The FDA currently relies on physicians and patients to report suspected adverse events. Often, it takes a number of cases before someone at the agency detects a pattern that's worth investigating. Then, it conducts an investigation to determine if the side effects were indeed caused by the drug. At the first hint of trouble, the FDA will now be able to query databases involving tens of millions of patients. It will not only be able to see the medications used, but whether a patient had lab work done or whether they had to be hospitalized.

The first batch of records the agency will have at its disposal will be from 25 million Medicare beneficiaries. Later, private companies will contribute medical data, said Health and Human Services Secretary Mike Leavitt.

"We're moving from a reactive dependence on voluntary reporting of product safety concerns to a proactive surveillance of medical products currently on the market," Leavitt said.