Drug Review Is Effective, Agency Says
|
|
When the Food and Drug Administration was forced to ban five prescription drugs in a recent one-year period, critics said the agency had compromised patient safety as it hurried new medicines to market. Today, the agency’s new commissioner responded, making public an internal review that found the agency’s emphasis on speedy drug approvals was not to blame. ”Has the standard been maintained at a high level?” Dr. Jane E. Henney, the Commissioner of Food and Drugs, asked during a briefing with reporters at the agency’s headquarters. ”The answer to that is yes. Adverse events are no greater now than when the system was slow.” The report, commissioned by Dr. Henney when she assumed control over the agency six months ago, took a wide-ranging look at the risks posed by products the F.D.A. approves and how the health care system copes with those risks. With many new drugs and medical devices coming into the market, the report concluded, Government and private industry must work together to develop a ”new framework” for reducing risk that will draw doctors, hospitals, pharmacists and patients into a dialogue about drug safety. ”In calling for a broader drug safety debate, this is a step forward,” said Thomas J. Moore, a health policy fellow at George Washington University Medical Center and a frequent critic of the drug agency. ”Saving lives and preventing injuries is going to have to involve doctors and patients and medical groups. It isn’t just a simple matter of blaming the F.D.A.” More : query.nytimes.com |