Refuting Inaccurate CER Results Is “Right” of Drug Sponsors, Temple Says

Feb. 13, 2012 – Dr. Robert Temple, the unofficial dean of drugs at the FDA, recently addressed one of the most perplexing issues in the post-health reform era – industry’s ability to fully participate in policy and pricing discussions on comparative effectiveness research (CER).

Companies are well aware that false or misleading CER findings can adversely affect their drugs’ prospects and this issue is becoming even more important as the federal government begins to fund more than a billion dollars of CER. However, some companies may believe that challenging CER findings is not allowed under FDA advertising and promotion regulations.

However, according to “The Pink Sheet” Daily, Temple, the Center for Drug Evaluation and Research deputy director for clinical science, said at a Feb. 9 conference that the FDA’s regulations do not preclude companies from challenging CER results that are false or misleading.

“Thank goodness Bob understands the problem and blasted open Pandora’s Box,” said Coalition Executive Director John Kamp. “Bob’s opinion is important, but not the last word, nor is it the opinion of most industry lawyers. The industry needs an official signal from the FDA that its participation in these discussions is appropriate and consistent with FDA marketing regulations.”

Temple said that FDA does not hold a view “that drug companies are condemned to silence about their products outside of formal promotion or perhaps published articles. If there’s something published that seems wrong, is based on poorly designed meta-analysis and so on, I don’t see any impediment to answer that and companies do answer that all the time.”

Temple did also note that companies must ensure that any rebuttal of CER findings are not promotional in nature, and that they should simply offer information and education about a product that is true to the product’s approved labeling.