Drug Safety

This is another noteworthy deal for Cerner, which as been the subject of rumors involving the massive NHS IT project in the U.K. The Kansas City-based maker of healthcare software appears to be making good on Neal Patterson's pledge to expand into new territory with the acquisition of Galt & Associates, a maker of drug safety and clinical data management systems. The Fairfax, VA-based company has 10 employees and recorded $9.5 million in revenue last year.

- see this article from the Business Journal of Kansas City

An inquiry by Congressional researchers finds that the FDA approach to drug safety has changed little despite criticism from consumer advocates and prominent critics in medicine. The GAO looked at the agency's handling of safety issues and found little evidence that the agency has improved its oversight of drugs once they hit the market. The report concludes that the FDA should be given more power to compel drug companies to complete post-marketing studies. The authors also argue that …

Bush is expected to nominate acting FDA head Andrew von Eschenbach for the permanent job at the agency within the next two weeks. Dr. von Eschenbach, who moved to the FDA from the National Cancer Institute, came in as a replacement for former chairman Lester Crawford last year after his sudden exit. Von Eschenbach moved to government from the MD Anderson Cancer Center in Houston. Confirmation hearings are likely to focus on controversial issues like the debate over the agency's handling …

> University of California Irvine Medical Center is expected to release an internal report on widespread problems at the hospital this week. Article

> An FDA panel created last year in response to the outcry over the safety of prescription drugs will meet privately. The Drug Safety Oversight Board should meet publicly to ensure public confidence, critics said …

A jury in Atlantic City, NJ, ruled in favor of drug maker Merck in the company's second trial involving the painkiller Vioxx. Jurors deliberated for little more than a day before rejecting former postal worker Frederick "Mike" Humeston's claim that his heart attack was caused by the drug. The jury also flatly rejected Humeston's argument that Merck committed consumer fraud when it marketed the drug to consumers and doctors.

The controversy over Cox-2 painkillers has led to an …

The Food and Drug Administration said it wants pharmaceutical companies to submit label information in an electronic format. Drug companies will now be required to submit prescribing and product information in the structured product labeling (SPL) format. The idea is to make sure that the latest drug safety information is readily accessible to both practitioners and consumers and that updates can made quickly. The FDA is also establishing DailyMed, a new Web site that will serve as a …

After a two year search, a new head of the FDA's Office of Drug Safety has been named. Dr. Gerald Dal Pan, an official with the Center of Drug Evaluation and Research who has been with the agency for five years, was appointed to the post Wednesday. The Office of Drug Safety is among the most closely watched units in the agency given recent concerns about FDA oversight of new drugs. Article

A news study conducted by researchers at Tufts argues that quicker FDA approval times for new drugs has had little or no impact on drug safety. That argument runs counter to critics who in part blame looser rules for the jump in safety problems in recent years. Researchers at the Tufts Center for the Study of Drug Development found that in the 1980s, 3.2 percent of drugs approved for sale in the US market were recalled. The authors note that since the year 2000, that number has fallen to …

On Friday the Food and Drug Administration announced contracts for its adverse event monitoring database, a key to the agency's plan for monitoring drug safety in the future. The FDA will use the technology to look for possible signs that a particular drug may be experiencing problems. The four organizations selected to participate in the project are Vanderbilt University, Harvard Pilgrim Healthcare, Ingenix and Kaiser Foundation Research Institute. Of course, since the Vioxx withdrawal …

Some Democrats in Washington are calling for an investigation into the circumstances surrounding former FDA Chairman Lester Crawford's abrupt resignation last week. Speculation has centered on the possibility that a potential financial conflict of interest was involved. Yesterday, the ex-chairman denied those reports, telling Forbes that his decision to depart was a result of burnout from the day-to-day stress of managing the agency at a time when it has been under fire over its …