FDA Presses Drugmakers to Publish Complete Response Letters

An FDA associate commissioner and five associates are pushing for greater transparency around complete response letters issued to drugmakers when marketing applications are denied.

CRLs are treated as confidential, leading to conflicting views on whether the information should be made public, according to a recent study published by the British Medical Journal. Some have called on the FDA to follow the lead of the European Medicines Agency and make the information public so that researchers, sponsors and clinicians can learn from previous failures. Others in the pharmaceutical industry consider any information in the CRLs to be proprietary and confidential.

The study of 61 CRLs issued from August 2008 to June 2013 showed that in 11 instances drugmakers didn’t release press releases and in 13 instances the press releases didn’t match any statements from the letters. Safety and/or efficacy issues were noted in 87 percent of the CRLs, the study notes.

The authors suggested three approaches to improve transparency:

• Sponsors could release CRLs;
• Sponsors could issue more complete press releases; or
• The FDA could make CRLs public, although this likely would require a change in regulations.

Disclosing the agency’s rationale for refusing approval would help to inform drug development and counteract misconceptions regarding FDA’s reasons for denial, the authors conclude.

Read the study at www.fdanews.com/06-15-15-coverletter.pdf. — John Bechtel