New FDA drug safety board to be more independent
pharmafile | February 17, 2005 | News story | Sales and Marketing |
A new independent FDA board will be set up to monitor drug safety and issue warnings to doctors and patients following intense criticism of the agency after Vioxx's withdrawal.
The new Drug Safety Oversight Board is to be established to make the FDA's decisions on drug safety more transparent and to assure the public and medical profession that guidance has not been unduly influenced by the pharma industry.
The DSB will oversee drug safety issues within the agency's existing Center for Drug Evaluation and Research (CDER) and will be made up of FDA and medical experts from other government health agencies and government departments, for instance the Department of Veterans Affairs who will be appointed by the FDA Commissioner.
Other medical experts and representatives of patient and consumer groups will be consulted but pharma companies will not be able to talk directly with the board unless invited.
Acting FDA Commissioner Dr Lester Crawford said: "FDA understands that the public expects better and more prompt information about the medicines they take everyday."
The FDA has been subject to fierce criticism in light of Merck's voluntary withdrawal of its arthritis drug Vioxx because of increased risks of heart attacks and strokes.
Dr David Graham, associate director of the FDA's Office of Drug Safety (ODS) told a Senate investigation in November that Vioxx's withdrawal was a "terrible tragedy and profound regulatory failure" – and furthermore that the US was "virtually defenceless" against a repeat of the incident.
Some research has now linked the increased cardiovascular risk to the other drugs in the Cox-II class, and the announcement comes just ahead of a decisive three-day FDA hearing into the class.
Alongside monitoring drugs on the market, the DSB will resolve disputes over scientific data and implement drug safety policies. The agency has also pledged to increase the number of fact sheets that patients receive with their prescriptions.
The board will make its conclusions public on a website, which will highlight emerging safety news on newly approved drugs although it will not have independent power to force the withdrawal of drugs.
Dr Crawford, who was recently nominated by President Bush to become the permanent commissioner of the FDA, made the announcement with Michael Leavitt, the secretary of health and human services.
"The public has spoken and they want more oversight and openness," Secretary Leavitt said during a meeting with FDA employees. "They want to know what we know, what we do with the information and why we do it. We will address their concerns by cultivating openness and enhanced independence."
The change is unlikely to appease some critics who had called for a drug safety body outside the FDA.
Dr Alastair Wood, an associate dean at Vanderbilt University, a long-term advocate of an independent review board, said he was disappointed.
"This is not my concept of what an independent drug safety board would be. This is reshuffling of the deck. It's a huge opportunity that's been lost to introduce transparency and restore confidence in the system," he said.
The US drugs industry has indicated that a separate body might hold back breakthrough medicines and place excessive emphasis on risk.
