The US Food and Drug Administration has acknowledged that drug safety in the country is not all it should be, but rejects claims that the blame lies purely at the door of the agency.
FDA deputy administrator, Janet Woodcock, giving testimony before a National Academy of Sciences’ Institute of Medicine committee, said that the agency has known for some time that it needed to improve its systems for finding out about side effects from drugs currently on the market, an issue which has risen to prominence after recent high-profile withdrawals, notably Merck & Co’s Vioxx (rofecoxib) [[01/10/2004a]].
However, according to the New York Times, she added that it serves little purpose to increase surveillance of the FDA’s activities as it is the whole health system – involving government, physicians, pharmacists and pharmaceutical companies – that needs overhauling.
Ms Woodcock said that “the keystone of the current system is the prescriber, and that person is the one who decides if the benefits of a drug outweigh the risks for that patient. This system has obviously broken down to some extent, as far as the fully informed provider and the fully informed patient.”
She added that the FDA is doing all it can to change and cited its plans to create an independent drug safety office [[16/02/2005a]], but this failed to satisfy Bill Vaughn of Consumer Union who told the IoM that “there seems to be no recognition of or urgency about the well-established need for significant and immediate policy reforms,” claiming that “because safety has taken short shrift at the FDA, people have died, unnecessarily and prematurely.”
However, Alan Goldhammer of the Pharmaceutical Research and Manufacturers of America said that “current legal authorities over drug safety are robust and need not be altered,” adding that voluntary reports of adverse reactions submitted by healthcare practitioners, must be carefully evaluated before they are made public. Premature claims that a medicine is unsafe “could confuse healthcare providers and also delay use of valuable therapies,” he concluded.
