Drug companies have yet to even begin nearly two in three of the follow-up studies they agreed to undertake once their medicines were on the market, according to a government tally released Friday.
Often the drugs received expedited approval from federal regulators on condition that the studies be carried out.
The Food and Drug Administration said in an annual report that, as of Sept. 30, 65 percent of the 1,231 so-called "post-marketing" drug studies that companies had pledged to carry out were still pending.
Dr. Alastair Wood, associate dean of Vanderbilt Medical School, said if the FDA doesn't require the studies to be done, it shouldn't ask for them in the first place.
"It's astonishing, really. Their job is to get the studies done and not be an apologist for their not getting done," Wood said.
The FDA says it relies on the so-called Phase 4 studies to gather additional information about a drug's safety, efficacy or use. The outcome of those studies can lead to changes in how a drug is made, prescribed and used. The FDA also can require the studies after it has approved a drug, including to better determine its safe use in children.
Courtesy of AP
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