The US Food and Drug Administration takes too long to approve new drug products and medical devices, according to 76% of orthopaedic surgeons polled for a new survey which also reveals that 80% believe that Merck & Co’s painkiller Vioxx which was withdrawn in 2004, should become available again.
The poll, which was conducted by the Competitive Enterprise Institute (CEI), a US free-market advocacy group, also found that 73% of the surgeons believe that FDA approval delays hurt their patients, while 58% claimed that the agency hinders their use of new therapies. Moreover, 70% said that they were in favour of changing the law to allow physicians to have access to unapproved therapies, provided that the products carry warnings to make clear their unapproved status.
This is the sixth survey of medical specialists conducted by the CEI – the first being a poll of oncologists in 1995 – and, in some respects, it represents “an exceptionally negative” view of the FDA, comments Sam Kazman, general counsel at the CEI. “The 60% who view FDA as hindering their use of new therapies is the highest recorded in any of our surveys. The same is true of the 58% who report that FDA has hindered their treatment of patients on more than one occasion,” he says.
Vioxx (rofecoxib) was included in the survey even though its withdrawal by Merck & Co in 2004 was voluntary, following safety concerns of an increased risk of cardiovascular events, including heart attack and stroke, in patients taking the drug. However, its continued absence from the market, despite an FDA panel’s recommendation that it be returned, illustrates how needed therapies can be blocked not only by FDA regulations but also by liability concerns, says the CEI.
“In recent years, the FDA has been repeatedly attacked for approving allegedly defective therapies. But as this physician survey shows, the real threat to public health is that FDA’s approval process is already too long. Any attempt to make it more stringent will only worsen this problem,” said Mr Kazman.
“All new therapies carry risks, and sometimes those risks cannot be discovered until after clinical testing. If we set a goal of zero unexpected risks, then the only way to meet that goal is through zero new therapies. As the results of this latest survey indicate, from a public health standpoint that could well be the riskiest approach of all.” he added. Lynne Taylor
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