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 A recent example with negative public health implications was Bextra® (valdecoxib), a drug withdrawn from the market for safety reasons.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.
David Hart
Sr. Assistant Attorney General
Oregon Department of Justice
Civil Enforcement Division
Thank you for your work on this important issue. Information is like air and water, people should have access to as much as they need.
Posted by: Christina Bowen | July 29, 2009 at 04:37 PM
Simply put, the disclosure rules ought to be the same for both approved and rejected applications. Does the existing law compel the agency to give preferential non-disclosure treatment to the rejected applications? -- I doubt that.
I applaud the FDA for already taking steps in the right direction. The case in point is the new drug application for asenapine. Although the overall conclusion of the FDA review appears to be positive, there has been a conflict among reviewers regarding safety and efficacy of asenapine. The FDA made the right decision to convene the advisory committee and to make public all 1000 pages of supporting documentation here http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM173877.pdf . Now, the outside experts can see both sides of the issue and make their own recommendations, no matter whether the drug will be approved or rejected. Way to go, guys!
Posted by: TSC | July 30, 2009 at 09:02 AM
Pretty good post. I just stumbled upon your blog and wanted to say that I have really enjoyed reading your blog posts.
Posted by: sulumits retsambew | August 05, 2009 at 10:13 PM
FDA cops a lot of flack generally. There will always be those of extreme views anyway, but the move to more transparency is definitely a step in the right direction. I fully support what is happening in this regard.
Posted by: Kevin | August 11, 2009 at 11:13 AM