IOM: Some drugs need post-approval safety tests

“Much of this information is already being gathered by FDA, but it is currently scattered across multiple records,” a release stated.

“Putting the information into an accessible format in a single document would make FDA’s commitment to the life-cycle approach concrete and improve its transparency by giving the public easier access to useful data.”

The IOM also recommended that the FDA require additional post-approval research in the case of drugs whose “benefits or risks are particularly uncertain.”

It stated that such cases could include ” ‘first in class’ drugs that have been approved based on surrogate endpoints used previously for other drug classes” and those with side effects that pose serious questions about risk.

An example of such a drug would be a blood pressure pill that causes weight gain, the study said.

“We believe that the adoption of a life-cycle approach to drug approval and monitoring will … increase public confidence in the agency’s ability to protect public health,” said Steven N. Goodman, a professor of medicine at Stanford University.

Goodman co-chaired the committee that authored the study, which examined “Ethical and Scientific Issues in Studying the Safety of Approved Drugs.”

Such additional regulatory actions will “become increasingly important as FDA looks for ways to safely expedite the drug approval process,” he said.