FDA warns GlaxoSmithKline about missing information

According to the letter, dated March 25 and posted April 8, GSK “failed to report multiple postmarketing studies involving Avandia in mandatory Periodic and/or NDA Annual Reports.”

The FDA cited GSK because:

• Not all GSK’s Periodic Reports contained a history of actions taken because of adverse drug experiences since the last adverse drug experience report
• Not all of GSK’s Annual Reports contained a status report for all post-marketing studies being performed by, or on behalf of, GSK
• Not all GSK’s Annual Reports contained the status of each post-marketing study concerning clinical efficacy required by FDA or which GSK committed to conduct

The violations outlined in the letter are “serious and may be symptomatic of underlying postmarketing safety reporting failures,” according to the FDA. The agency recommended GSK take immediate action to avoid possible regulatory action, including seizure and/or injunction.