Many U.S. post-approval drug studies unfinished
|
|
Nearly two thirds of more than 1,200 post-approval drug studies promised by the manufacturers have yet to start, according to U.S. government statistics released on Friday.
An annual report by the Food and Drug Administration showed little change from recent years in the percentage of studies that remain unfinished, officials said.
“The percentages of open commitments, pending, ongoing, delayed, terminated and submitted (studies) are all in the same ballpark range,” Dr. John Jenkins, director of the FDA’s Office of New Drugs, told reporters.
Most of the studies were voluntarily agreed to at the time of FDA approval, and the agency has no power to force companies to complete the research.
Some studies were required in exchange for faster approval of drugs for life-threatening diseases such as cancer or AIDS. In those cases, the FDA can withdraw a drug’s approval if a study goes unfinished, but has never done so. Officials did not say how many drugs had requirements for mandatory studies.
Last month, the agency said it would seek suggestions from an outside group on ways to make sure drug companies complete more post-approval studies. Regulators say the follow-up data can provide important new details about safety and effectiveness.
In its report released Friday, the FDA said 65 percent of 1,231 open studies for chemical-based drugs were “pending,” meaning they had not started but were not yet considered delayed. Many of those studies were agreed to years ago before the FDA gave timelines, which makes it difficult to say if they are behind schedule, Jenkins said.
In the past few years, the FDA has attached schedules for study enrollment and completion.
Two percent of the studies were considered delayed, while 19 percent were on schedule. Drug makers had submitted final reports on 14 percent of the studies.
Jenkins said about 300 of the 797 pending studies were requested in fiscal years 2004 or 2005, “so you might not be surprised those are still pending.” He said it can easily take six to 12 months to get a study up and running.
For biologic drugs derived from living things, only 37 percent were pending and 29 percent were on schedule. But 17 percent were deemed delayed.
The drug industry said it was time-consuming and sometimes difficult to enroll patients in studies of drugs already on the market. The FDA report should not be “distorted,” said Alan Goldhammer, associate vice president for scientific and regulatory affairs at the Pharmaceutical Research and Manufacturers of America.
“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,” he said in a statement.
Consumer group Public Citizen said Congress should give the FDA power to levy large penalties to punish companies that leave studies unfinished.
“The great majority of post-marketing studies address safety issues, at least in part, so patients and physicians are denied critical safety information when these studies are not completed in a timely fashion,” Peter Lurie, deputy director of Public Citizen’s Health Research Group, said in a statement.
Print Version
Tell-a-Friend comments powered by Disqus
