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  A recent example with negative public health implications was Bextra® (valdecoxib), a drug withdrawn from the market for safety reasons.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

The Transparency Task Force is trying something new. Every once in a while, we will post a comment we have received on this main page. The Task Force would like to hear from more people about the views expressed in these comments. These comments will be from a diverse group of stakeholders and each comment will present a view about transparency at FDA. We will ask the author before reposting the comment here.

The views and opinions expressed in these comments are those of the authors only and should not be regarded as those of the Transparency Task Force or FDA. The comments are posted by the Transparency Task Force simply to facilitate discussion.

The first posting is from Jeffrey Francer of the Pharmaceutical Research and Manufacturers of America.

The Pharmaceutical Research and Manufacturers of America (PhRMA) is highly supportive of the FDA’s transparency initiative, because transparency fosters accountability. It is important to acknowledge that the FDA is already one of the most transparent public health agencies in the world. It is hard to imagine any other similar government agency that provides on its web page all of its: approval letters, warning letters, advisory committee briefing materials, summary bases of approval, internal standard operating procedures, guidance documents, regulations, citizen petitions, as well as product-specific details on risk management programs and emerging safety information.

That said, the FDA’s mission requires that we make sure that the agency is communicating to healthcare professionals and the public as effectively as possible. PhRMA believes that the FDA can do even more to explain its approval decisions and other important regulatory actions to healthcare professionals and to patients. Put simply, FDA should make it obvious, to those who are interested, how scientific data leads to its approval decisions.

At the same time, it is critical to balance increased transparency with the need to encourage biopharmaceutical manufacturers to develop important medical advances in a competitive manner. Simply put, increased disclosure requirements that fail to protect innovative research and development investments will harm, rather than help improve, the public health. PhRMA looks forward to continuing the dialog begun by the FDA’s Transparency Task Force at its public meeting last week

In line with FDA’s Transparency Task Force efforts, FDA is encouraging public comment on the Sentinel Initiative. The Sentinel Initiative is an FDA collaborative effort to develop a national electronic system (Sentinel System) that will transform FDA’s ability to track the safety of drugs, biologics, medical devices—ultimately all FDA-regulated products—once they reach the market.  By seeking public comment via an open discussion room, FDA is expanding its ability to get new ideas and guidance from the public in near real time. To contribute ideas on the Initiative and related documents, please visit http://www.fda.gov/Safety/FDAsSentinelInitiative/default.htm.

On June 24, we held our first public meeting to hear ideas from the public about transparency at the agency.  During the meeting, some attendees told us that the FDA should use its website, www.fda.gov, to improve communications with the public. The task force would like continue this conversation and hear from more people about how FDA can use the website to be more effective in providing useful and understandable information to the public. 

Our question is:

How can FDA use its website to improve transparency at the agency?   

Thank you and we look forward to your input and participation.

FDA Transparency Task Force