FDA Will Monitor Medical Records Of Medicare Beneficiaries
 |
HHS on Thursday announced the creation of a new program that will allow FDA, state agencies and academic researchers to use medical record data to ensure drugs and medical devices are safe for consumers after they enter the market, the Washington Post reports (Stein, Washington Post, 5/23). The so-called “Sentinel Initiative” has been discussed for years, according to the New York Times. In 2005, HHS Secretary Mike Leavitt asked FDA to explore launching such a program. In 2006, the Institute of Medicine recommended the creation of a drug-monitoring program. In fall 2007, Congress passed legislation (HR 3580) that required the creation of a drug-monitoring program and President Bush signed it into law (Harris, New York Times, 5/23).
Sentinel will begin by allowing access to data from more than 25 million Medicare drug benefit beneficiaries (Washington Post, 5/23). The Medicare data will become available in 30 days under the regulation announced on Thursday, according to the AP/San Francisco Chronicle (Freking, AP/San Francisco Chronicle, 5/22). Leavitt said FDA also is speaking with private insurers about allowing their plans’ data to be included in Sentinel. WellPoint last month said it plans to contract with FDA to provide data from its plans. According to Bloomberg/Boston Globe, WellPoint has 35 million members, more than any other insurer (Bloomberg/Boston Globe, 5/23).
Full Story: FDA Will Monitor Medical Records Of Medicare Beneficiaries
Source: kaisernetwork.org
(No Ratings Yet)
Loading ...
Comments
Leave a Reply