New measures aim to improve drug safety

Friday, November 5th 2004, 11:17 am
By: News On 6

WASHINGTON (AP) _ Buffeted by criticism, the Food and Drug Administration said Friday that it would appoint a director of drug safety and take other steps to improve the safety of medications.

Critics charge the agency ignored risks associated with antidepressants and the blockbuster drug Vioxx, then intimidated its own reviewers when they pointed to safety concerns in both cases. As sick and elderly Americans competed in lotteries for scarce flu vaccine, members of Congress chided the FDA for relying on the word of Chiron, the vaccine manufacturer, rather than investigating as aggressively as British regulators.

``Medicines that receive FDA approval are among the safest in the world; the measures we are taking are designed to strengthen this quality as well as our consumers' confidence that FDA's processes ensure the highest protection of the public health,'' Lester M. Crawford, acting FDA commissioner, said in a statement.

FDA's Center for Drug Evaluation and Research will fill the vacant post of director of the Office of Drug Safety to oversee the safety of drugs after they have been approved for use.

In addition, the agency will sponsor a study by the Institute of Medicine, the health care arm of the National Academy of Science, to look at the effectiveness of the agency's drug safety oversight. The study will take a closer look at whether improvements are needed to tease out more details of a drug's side effects as it is more widely used.

The FDA also said it would begin a program to bridge differences of opinions among its scientific reviewers.

Because ``such disagreements can have a potentially significant public health impact,'' Crawford said the agency will convene an independent panel to review documents and make recommendations within 30 days to resolve those disputes.

Crawford said the agency's clinical reviewers and epidemiologists ``evaluate and respond to identified concerns. This is what occurred recently with antidepressants and Vioxx.''

Yet, in both cases reviewers told members of Congress they faced resistance within the agency after raising red flags.

This week, the FDA released David Graham's report on Vioxx in which the associate director for science said ``disturbingly'' he found evidence of increased cardiovascular risks among people taking the drug continued to mount after a 2000 study and another study linked the drug to ``significantly increased'' risk of hospitalization for gastrointestinal bleeding.

Also, the editor of the journal Lancet this week lashed out at the FDA, pointing to ``lethal weaknesses'' in its regulatory oversight. ``Unacceptable cardiovascular risks'' with Vioxx were clear four years before Merck withdrew the drug, Lancet editor Richard Horton wrote.

``Too often, the FDA saw and continues to see the pharmaceutical industry as its customer _ a vital source of funding for its activities _ and not as a sector of society in need of strong regulation,'' Horton wrote in the editorial.

The FDA statement did not directly respond to the Lancet criticism.