Wednesday, January 31, 2007

FDA to Monitor Post-Market Drug Safety

By Amanda Gardner
HealthDay Reporter

Tuesday, January 30, 2007; 12:00 AM

TUESDAY, Jan. 30 (HealthDay News) -- In an apparent attempt to address growing criticism of its operations, the U.S. Food and Drug Administration unveiled a set of initiatives Tuesday that are intended to bolster the country's health safety net.

The recommendations include a pilot project to assess the safety of drugs after they're on the market, as well as initiatives to improve communication both within and without the beleaguered agency.

Speaking of the need to build trust, FDA Commissioner, Dr. Andrew C. von Eschenbach, told reporters at a news conference, "The world is changing, so the FDA must change to continually achieve progress in its ability to determine the safety and effectiveness of the products we regulate. These initiatives today are not the whole story or the final chapter, but they are a major part of the story."

But critics quickly countered that the recommendations didn't go far enough.

"The FDA's [report] includes some minor improvements, such as more sharing of safety data with other agencies, but falls dramatically short of the changes needed to overhaul the nation's drug safety system," senior policy analyst Bill Vaughan of Consumers Union said in a prepared statement.

Many of the initiatives announced Tuesday are in response to recommendations in an Institute of Medicine (IOM) report issued in 2006 and prepared at the request of the FDA. Those recommendations included a push for stronger post-marketing surveillance of approved drugs.

"This report represents our deliberate response to the IOM report," said Randall Lutter, acting deputy commissioner for policy at the FDA, at the news conference. "We are in substantial agreement with most of the IOM recommendations."

In addition to the IOM report, the agency has received substantial criticism for post-market safety questions involving the popular painkiller Vioxx, which was eventually withdrawn from the market, and other drugs.

Another drug, the multiple sclerosis medication Tysabri, was pulled from pharmacy shelves in early 2005 after several patients in clinical trials developed a rare but deadly viral infection in the brain. Tysabri was returned to the market in 2006, but under much stricter guidelines.

On Tuesday, the FDA proposed to strengthen the drug safety system with three basic efforts.

First is strengthening the science supporting the FDA's medical product safety system, including new ways to detect and predict adverse events and reassess drug benefits and risks.

"We can move from just counting side effects to actually preventing and controlling them," said Dr. Janet Woodcock, FDA's deputy commissioner and chief medical officer.

This effort also includes a pilot project to assess the safety of new drugs after they've been on the market for 18 months.

"We'll assess this pilot program for wider implementation after we've run several products through it," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research (CDER).

Consumers Union, however, pointed out that most safety problems don't become apparent until a drug has been on the market for five to seven years.

"Reviewing drugs for safety after 18 months is a good start, but we need periodic, consistent reviews of drugs on the market to catch these major safety issues," Vaughan said.

Galson also announced a new data-sharing agreement with the Veterans Administration to "improve patient safety through better access to data." The agreement is expected to be one of several.

The second part of the overall effort involved improving communication among all parties involved in the drug safety process.

Finally, the recommendations called for changing CDER internal culture and instituting organizational and managerial changes.

"We agree with the IOM about the need to improve the culture at FDA and CDER throughout the life cycle of drugs we regulate," Galson said.

Lutter said the agency would issue a report a year from now on how the recommendations are being implemented.

More information

SOURCES: Jan. 30, 2007 Food and Drug Administration teleconference with Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs; Janet Woodcock, M.D., Deputy Commissioner and Chief Medical Officer, FDA; Steven Galson, M.D., Director, Center for Drug Evaluation and Research, FDA; Randall Lutter, Ph.D., Acting Deputy Commissioner for Policy, FDA; statement, Jan. 30, 2007, Consumers Union