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Just Wasn't in the Cards?

Drug companies often don't disclose in press releases or regulatory filings why the US Food and Drug Administration has declined to approve their new drugs, Ed Silverman at Pharmalot reports.

An analysis appearing in the BMJ from FDA researchers compared complete response letters from the agency to press releases issued by various companies. Nearly half of the letters noted deficiencies in both safety and efficacy. For 18 percent of complete response letters, companies issued no press releases, and for those that did, 21 percent of the releases had statements the authors say didn't match what was in the letters.

Silverman cites other sobering findings from the analysis: seven letters said that patients in the trial had a higher mortality rate than controls, but only one press release noted this.

"Our analysis suggests that press releases are generally an incomplete source of reasons for FDA non-approval of applications," the study authors write. "The potential benefits of publicly disclosing the agency's detailed rationale for refusing approval include better informing the development of new drugs, facilitating a richer public health discourse, and counteracting misconceptions regarding FDA's reasons for denial of applications."

Silverman notes that the FDA considers these letters to be confidential and does not publicly disclose them, and wonders whether this will spur the agency to change.

FDA's Peter Lurie, one of the study authors, tells him that the agency "is considering the full range of policy options and will use these data in doing so."