Neal Parker, of AbbVie, says that while there is a lot of information that is released to regulators as part of the approval process, some information is "protected for the good of us all."
He says that the following information is currently made public in new drug applications (NDAs) to regulatory agencies: (1) safety reports and assessments, (2) clinical trial results, which are also published in journals and presented at conferences.
Parker says that how to release "what is left over" is decided on a company-specific basis via product-by-product analysis. Each company must be permitted on its own, says Parker, to determine what information to protect to prevent competitive harm. In other words, companies can decide what information to suppress or hide from regulatory agencies, health professionals, and the public, to prevent the commercial interests of companies.
Parker briefly provides AbbVie's approach to disclosure. He notes that the following categories of information may be considered commercially confidential information (CCI) and, thus, must be kept confidential by the regulatory agency:
Subject-level data, including
(i) Demographic data
(ii) Lab results
(iii) Adverse events
Study-level data, including
(iv) Subject-level data organized into data sets to be used in interpreting the outcome of the study.
Parker notes that this information "may be considered confidential because it can be used by other companies to get competing products approved more quickly and that makes the information commercially valuable to [companies]." Further, Parker notes that AbbVie is willing to release limited information within constraints to "advance science," but what is missing here is that the regulatory agencies need the subject-level data, including adverse events data, to not only knowledgeably approve or reject NDAs, but also provide physicians and their patients with all of the necessary safety information when prescribing or consuming medications, respectively.
Upon being questioned, Parker argues that adverse events are commercially confidential information because "if adverse events are reflected in either patient-level data or in study-level data, that information can be ... photocopied ... including the adverse events ... and perhaps do a bioequivalence study and I can get a product on the market. That steals my company's data."
"There are internal deliberative processes, thoughts, product of our scientists, that are used to frame data, present data, organize data, and argue or present that data to the regulators in a fashion that we believe supports the safety and effectiveness of our products. That information, including adverse events ... is confidential commercial information because if released, other companies could use it to help them get their products approved," says Parker.
See the video recording of the session here. Minutes 11:30-24:00 are those in question: http://www.youtube.com/watch?v=54OY1auPQqU&feature=youtu.be&t=11m30s#!
*Thanks to Lejla Halilovic for pointing me to this conference video.