|
|
| |
Psoriasis advocacy group, speaking at FDA hearing, urges FDA not to slow drug approvals as response to COX-2 NSAIDs controversy
(February 17, 2005) Psoriasis Cure Now, a nonprofit patient advocacy group, today urged a joint hearing of two Food and Drug Administration Advisory Committees to tread carefully as it prepares to issue recommendations about COX-2 selective non-steroidal anti-inflammatory drugs. Speaking before the Committees Thursday, the president of the group reminded the panels that 6.5 million Americans with psoriasis need additional treatment options, the approval of which could be jeopardized by the wrong response to the COX-2 controversy.
“Based on what we have heard to date, any errors surrounding the COX-2’s appear to be failures in post-approval monitoring, rather than errors in the initial approval of the drugs,” said Michael Paranzino, president of Psoriasis Cure Now. “One concern we have is that the Monday morning quarterbacking and scapegoating we are now seeing could make the FDA timid when deciding whether to approve new drugs in the future. Psoriasis and psoriatic arthritis patients need additional therapeutic options, and slowing down the approval process would be the wrong reaction to this crisis, one that would harm patients.”
Several COX-2 inhibitors have recently been implicated in causing heightened rates of heart attacks and strokes, and Merck withdrew its drug Vioxx in September because of these effects. Today is the second day of a three-day hearing of independent experts who will make recommendations to the FDA. The FDA often follows the counsel of their Advisory Committees, but is not required to do so. More than one million Americans have psoriatic arthritis, and many of those patients use anti-inflammatory painkillers to cope with their incurable and progressive disease.
“Many psoriatic arthritis patients are in a difficult spot, alarmed by recent reports of the apparent risks of these drugs, yet reliant on these medications to maintain their quality of life,” Paranzino continued. “These new revelations underscore the need for continued research on drugs after they are FDA-approved, as well as additional NIH funding to help develop a next generation of drugs that provide comparable relief with lower risk. But the FDA must not flinch from continuing to approve new drugs expeditiously, to meet urgent patient needs.”
The Psoriasis Cure Now written statement to the FDA panel is available here, as well as in PDF format directly from the FDA web site here.
|
|
|
|
