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Drug companies lag on follow-up studies for medicines

797 post-marketing reports pending

Mar 4, 2006 | AP
Drug Manufacturing

Drug Companies Have Yet To Even Begin Nearly Two In Three Of The Follow-Up Studies.

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 their manufacturers then carry out so-called "post-marketing" studies. The outcome of those studies can lead to changes in how a drug is made, prescribed and used.

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.

"That doesn't mean they will never be started," said Dr. John Jenkins, director of the FDA's Office of New Drugs.

Of the 797 studies still pending, commitments for 116 of them were made during the previous year. The clinical trials can take six months to a year to design and launch, Jenkins said.

Some Studies Had Been Agreed To Years Earlier.

Some studies had been agreed to years earlier, but the FDA didn't provide a breakdown. The pending studies represent a slight dip from the 812 still pending as of a year earlier, according to FDA documents.

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.

Alan Goldhammer, of the Pharmaceutical Research and Manufacturers of America, an industry group, said the figures should not be "distorted."

"To be clear, pending does not mean delayed. It does mean, however, that the immense and vitally important tasks of developing research protocols, finding investigators and researchers and even recruiting patients to participate in the study is in process," Goldhammer said.

Dr. Jerry Avorn, a Harvard Medical School professor and author of "Powerful Medicines," in which he criticizes the FDA's post-marketing system, said the numbers show the system is broken.

"This new information is an embarrassing continuation of similar reports issued by FDA each year on the appalling state of the medication safety studies it has `mandated' drug manufacturers to perform," Avorn said.

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