Privacy Groups Question RFID Use in Medicine Tracking
By Todd R. Weiss
As the U.S. Food and Drug Administration considers the use of radio frequency identification tags to help fight counterfeit prescription drugs, privacy advocates are cautiously watching to be sure consumer privacy isn't lost in the process.
Last year, the FDA called for the widespread use of RFID tags to help ensure that drugs sold to consumers are legitimate. Under the FDA proposal, RFID tags would be used on cartons and pallets of drugs throughout the pharmaceutical supply chain by 2007.
The problem, according to privacy advocates, is that the FDA is considering more than just tracking large shipping containers or crates of medicines with RFID tags; it could also use the tags to track individual medicine bottles or even individual tablets. That, privacy advocates said, would be invasive. more
FDA Awards Contracts on Databases of Adverse Effects
The U.S. Food and Drug Administration (FDA) earlier this month announced that Center for Drug Evaluation and Research (CDER) had awarded four contracts that give the FDA access to databases that significantly strengthen the FDA's Drug Safety Program by helping the agency evaluate the safety of new drugs faster and more effectively. The contracts represent another important advance in FDA's continuing work to improve the management of risks associated with marketed medications.
In the past, FDA's collaboration with researchers who have pharmacoepidemiologic databases to investigate suspected associations between drug exposures and adverse events was through a cooperative agreement (i.e. grant) mechanism. In order to increase both accountability for and control over the funds obligated to this effort, FDA decided to change the way it gained access to these data. Effective September 23, 2005, this collaboration will occur thru a contract mechanism. The contracts will also allow FDA more flexibility and access to a wider range of data resources.
The databases contain medical claims of health care encounters and outpatient prescription drug use which can, in turn, be used to study the association of various medicines with serious adverse effects. The databases provide an additional tool that will enable the FDA to more quickly uncover rare side effects that sometimes become apparent only after drugs are approved and given to many thousands or millions of patients.
The databases represent a variety of health care settings including health maintenance organizations (HMO's), preferred provider organizations, and state Medicaid programs. For some drug safety questions, collaboration between database resources will be possible, providing FDA with enhanced capacity to keep consumers better informed about the risks and benefits of the products they use so they can make the best possible decisions about their health.
The recipients of the contracts are Ingenix, Inc.; Kaiser Foundation Research Institute; The Vanderbilt University; and Harvard Pilgrim Health Care, Inc.
The following links provide information on each contract: Ingenix, Inc.
http://www.fbo.gov/servlet/Documents/R/436354; Kaiser Foundation Research Institute
http://www.fbo.gov/servlet/Documents/R/436358; The Vanderbilt University
http://www.fbo.gov/servlet/Documents/R/436362; Harvard Pilgrim Health Care, Inc.
http://www.fbo.gov/servlet/Documents/R/436376
Readers Respond to Crawford's Departure
By John Russell
Many readers responded to Bio-IT World coverage of Lester Crawford's decision to quit his post as FDA Chairman, and a several offered names of people they would like to see assume the post. Crawford had just shed the "acting" part of his title. Early reports suggest unreported financial dealings may have prompted his departure, but many thorny issues dogged FDA under Crawford's short tutelage. more
Progress Slow on HIPAA Security Rules
By Jaikumar Vijayan
Almost five months after the data security rules mandated by the Health Insurance Portability and Accountability Act went into effect, many health care companies still aren't fully compliant with them, according to IT managers and analysts.
They said technology, process and budgetary issues continue to delay compliance efforts, along with what is seen as a weak enforcement component that has many health care organizations feeling that they can take a wait-and-see attitude toward the rules. more
