According to the report, there is an inordinate delay in taking action on companies which practice off-label prescribing. While the federal agencies take approximately seven months to issue a warning to drug company peddling prescription medications, it takes another four months for the company to fix the problem.
Although drug companies are forbidden to promote medications for uses that have not been validated by the FDA on evidence from clinical trials, doctors can use their own independent judgment in prescribing medicines. The new FDA guidance proposed in 2008 also allows drug companies to distribute scientific articles that suggest new and unapproved uses for medications to doctors.
The report also highlighted FDA’s inability to monitor companies that are marketing drugs for unapproved uses. The report revealed that insufficient staff and lack of proper tracking systems have hampered FDA’s effectiveness in curbing the mushrooming tendency of ‘off-label’ prescribing. According to a 2006 study, more than 20% of prescriptions written in the US are for off-label use.