FDA Announces Effort To Boost Safety Monitoring of Rx Drugs

On Thursday, HHS 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 that FDA is speaking with private insurers about allowing their plans' data to be included in Sentinel.

Last month, WellPoint 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).

Currently, FDA uses self-reporting to discover adverse reactions. According to the Los Angeles Times, self-reporting from health care providers reveals an estimated 1% to 10% of problems with drugs and medical devices.

Because U.S. seniors are large consumers of prescription medications, "Medicare's trove of inpatient, outpatient and prescription plan data is considered particularly rich," the Los Angeles Times reports (Alonso-Zaldivar, Los Angeles Times, 5/23).

Acting CMS Administrator Kerry Weems said the initiative also could help reduce the $900 million spent on treating outcomes of adverse drug events each year. He added that data collected by Sentinel will be used for comparative effectiveness -- a study technique that compares cost and effectiveness of treatments (Armstrong, CQ HealthBeat, 5/22).

Federal officials in two news conferences announcing the initiative repeatedly assured that FDA and other agencies with access to the data would not have access to personal information of Medicare beneficiaries, according to the New York Times (New York Times, 5/23).

"FDA will not receive information that identifies individual patients, so patient privacy will remain protected," Leavitt said (Washington Post, 5/23).

Mark McClellan, former Medicare administrator and a senior fellow at the Brookings Institution, said the initiative was a good model for preserving patient privacy because the data stay with an insurer, within a medical practice or within Medicare, according to the AP/Chronicle. McClellan added that FDA does not need personal information for the initiative.

"What FDA mainly needs to know is what's going on in the population being treated by all these different components of our health care system," McClellan said (AP/San Francisco Chronicle, 5/23).

According to the New York Times, there could be "several problems" with the Sentinel Initiative.

Medicare data, which are collected only when a doctor, hospital or other medical provider seeks payment, are "far less accurate" than patient health records, the New York Times reports.

In addition, the data could be skewed because patients are already sick before they receive the medication. Also, Medicare beneficiaries on average receive 28 prescriptions annually, compared to an average of 13 for all U.S. residents, which could make it difficult to determine which treatment is at fault for complications (New York Times, 5/23).

The pharmaceutical industry is concerned Sentinel will raise unnecessary worries because the analysis of data will not be as rigorous as a clinical trial, the Wall Street Journal reports.

However, FDA Center for Drug Evaluation and Research Director Janet Woodcock said that the agency will work with its partners in the public and private sectors to help subdue false conclusions (Favole/Mundy, Wall Street Journal, 5/23).

Pharmaceutical Research and Manufacturers of America Senior Vice President Ken Johnson said that the trade group supports Sentinel "because it allows regulators and health care professionals to move from reliance on voluntary reporting of side effects to proactive monitoring of medicines" (New York Times, 5/23).

Leavitt said, "Before Sentinel, tracking drug safety was like looking at the stars in your back yard with the naked eye. After Sentinel, it's like giving you the strongest telescope on the market, which allows you to see precise details in great distances" (Washington Post, 5/23).

Weems said, "The reduction of adverse drug events will not only promote the health care of our beneficiaries but is a key step in reducing unnecessary costs to the Medicare trust fund" (Young, The Hill, 5/22).