Thursday, Feb. 1, 2007
Already Approved for the Market
Underscores need for major reform of drug safety laws
(Washington, D.C.) – Despite being plagued by major safety problems in recent years, drug makers have failed to initiate more than 70 percent of promised studies on drugs already approved for the market, according to the latest numbers from the Food and Drug Administration.
A report posted today by the FDA shows that 899 — or 71 percent — of the 1,259 post-market studies committed to by drug makers had not been started as of Sept. 30, 2006. That’s an increase of 5 percent over last year, when the FDA reported that 65 percent of the promised 1,231 studies were still pending, according to Bloomberg News.
“How can the FDA claim it is committed to improving drug safety when it can’t even get drug makers to do the studies they promise?” said Bill Vaughan, senior policy analyst with Consumers Union. “Should consumers really feel safe when two out of three studies aren’t being done, and the FDA doesn’t even have the authority to get them done?”
The report found that only 185 — or 15 percent — of studies were ongoing, 31 were delayed, and 144 were submitted.
Consumers Union is urging Congressional passage of drug safety reform legislation that would, among other things, give the FDA the authority to require post-market studies of prescription drugs with outstanding safety issues.
Currently, some drugs are approved with outstanding safety concerns on the promise that the drug’s maker will perform post-market safety studies to determine if the medication causes side effects over a period of time. But the FDA has no authority under law to require those studies be performed.
“The fact that drug makers are ignoring their own promises to perform safety studies shows how desperately we need stronger laws to protect the public,” Vaughan said. “Drug makers are getting away with a wink and a nod when it comes to these promised studies, and that is simply not right.”
Contact: Bill Vaughan, 202-462-6262