POSTAPPROVAL DRUG STUDIES ARE BEHIND

Pharmacy Times, Volume 0, 0

Drug manufacturers are not keeping their promise to the FDA regarding postapprovaldrug studies, and the pattern has been occurring for years. An annual report by the FDAshowed that nearly two thirds of >1200 postapproval drug studies have yet to start.

"The percentage of open commitments, pending, ongoing, delayed, terminated, and submitted[studies] are all in the same ballpark range," said John Jenkins, MD, director of theFDA's Office of New Drugs.

The FDA's hands are tied because a majority of the studies were voluntarily agreed to atthe time of FDA approval, and the agency has no authority to force companies to completethe research. Some studies were required in exchange for quicker approval of drugs forlife-threatening diseases. In those cases, the FDA can withdraw a drug's approval if a studygoes unfinished, but there is no record of the agency's having done so.

The FDA's report found that 65% of 1231 open studies for chemical-based drugs were"pending," meaning that they had not begun but were not considered delayed. A majorityof those studies were agreed to years ago before the FDA issued timelines—which makesit hard to say whether they are behind schedule, according to Dr. Jenkins.Of the open studies,2% were considered delayed, and 19% were on schedule. Drugmakers had submittedfinal reports on 14% of the studies.