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FDA says firms still lagging on follow-up drug studies

WASHINGTON -- Drug companies have yet to even begin nearly two out of three of the follow-up studies they agreed to undertake once their medicines were on the market, according to a government tally released yesterday.

Often the drugs received expedited approval from federal regulators on the condition that the studies be carried out.

The Food and Drug Administration said in an annual report that 65 percent of the 1,231 so-called postmarketing drug studies that companies had pledged to carry out were still pending by Sept. 30.

''That doesn't mean they will never be started," said Dr. John Jenkins, director of the FDA's Office of New Drugs, explaining that 116 of the 797 studies were committed to during the 12 months ending in September. The clinical trials required under the commitments can take six months to a year to design and launch, he said.

Some studies had been committed to years earlier, but the FDA didn't provide a breakdown.

The 797 pending studies represent a slight dip from the 812 still pending a year earlier, according to FDA documents.

Kathleen Quinn, FDA spokeswoman, said the agency feels that ''these numbers show drug companies are taking this thing seriously."

Dr. Alastair Wood, associate dean of Vanderbilt Medical School, said that if the FDA does not require the studies to be done, it should not ask for them in the first place.

''It's astonishing, really," he said. ''Their job is to get the studies done and not be an apologist for their not getting done."

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

''To be clear, pending does not mean delayed," he said. ''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."

Dr. Jerry Avorn, a Harvard Medical School professor and author of ''Powerful Medicines," in which he criticizes the FDA's postmarketing system, said the numbers show that 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," he said. ''It is scandalous that of the supposedly active studies, about two-thirds haven't even been started yet."

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 can also require the studies after it has approved a drug, including to better determine its safe use in children.

The report, posted to the FDA website, lists 231 studies as ongoing, 28 as delayed, and three as terminated as of Sept. 30. Another 172 studies are listed as completed or terminated, with a final report submitted to the agency.

The report also tallies studies required of biological products, which include vaccines, blood components, and transplant tissues. Of 321 such study commitments, 118, or 37 percent, remained pending by Sept. 30. Another 56 were completed by that date.

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