For Further Discussion — Comment from the Public About Transparency
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