For Further Discussion — Comment from the Public About Transparency #2
The views and opinions expressed in this comment are those of the author only and should not be regarded as those of the Transparency Task Force or FDA. The comment is posted by the Transparency Task Force simply to facilitate discussion.
My recommendation relates to cases where FDA does not approve one of the indications requested in a New Drug Application (NDA) or does not approve an indication requested in a Supplemental New Drug Application. In such cases, FDA should make public the “non-approval letter” explaining why the indication was not approved, the relevant analysis by FDA’s medical officer and all clinical trials that were the basis for FDA’s non-approval. When a drug is marketed for at least one approved indication, it is foreseeable it will also be prescribed off-label for related indications, especially in cases where approval of the off-label indication has been sought. A recent example with negative public health implications was Bextra® (valdecoxib), a drug withdrawn from the market for safety reasons.
As a Senior Assistant Attorney General in the Consumer Protection section of the Oregon Department of Justice, I led an investigation by a coalition of 34 State Attorneys General regarding the off-label promotion of Bextra to treat acute and perioperative pain. This matter was resolved with a Stipulated General Judgment filed in Marion County Circuit Court. In our Complaint we alleged, among other things, that after FDA refused to approve an application to market Bextra for acute and perioperative pain, the drug company went ahead and promoted these indications by distributing hundreds of thousands of copies of a positive study from the NDA without discussing or presenting a negative study from the NDA that was the basis for FDA’s refusal to approve. Had FDA made public the non-approval letter, the analysis by the FDA medical officer assigned to review the NDA, and the relevant clinical trials, it would have been more difficult, if not impossible, to promote the drug off-label for these indications.
Sr. Assistant Attorney General
Oregon Department of Justice
Civil Enforcement Division