Companies were also more likely to issue press releases when their drug application was for the first in a new family of medicines.
Making the full contents of complete response letters public would allow the FDA to increase transparency and combat misconceptions about why regulators refuse approval for new drugs, Lurie said. Doing this would probably require a change in FDA regulations, he added.
Public access to these letters would help patients better understand the risks and benefits of medications, particularly when the complete response letters are issued for new uses of previously approved drugs, said Barbara Mintzes, a professor of pharmacy at the University of Sydney and author of an editorial accompanying the study published June 10 in the BMJ.
Even though companies aren’t allowed to advertise drugs for unapproved uses in the U.S., doctors are free to prescribe medicines for what’s know as off-label use, Mintzes said by email.
“Doctors who are considering prescribing a drug for a specific use would likely reconsider if they knew the FDA had rejected an application for marketing for that specific use,” Mintzes said.
“Medicines are important treatments but they are capable of causing harm as well as benefit, and harmful drug reactions are a leading cause of death and hospitalizations,” she said.
