EMA Challenges FDA: Releasing Clinical Study Reports
Two Johns Hopkins University professors say that the European Medicines Agency’s (EMA) 2016 publication on its Web site of clinical study reports for carfilzomib (Amgen’s Kyprolis) and lesinurad (Ironwood’s Zurampic) puts pressure on FDA to change its long-standing position that such reports are confidential commercial information and not to be publicly shared. Writing in the Journal of the American Medical Association, the public health researchers say the “proactive publication of clinical study reports by a drug regulatory agency is unprecedented but heralds progress toward greater transparency.”
In 2010, the EMA announced that subject to adequate protection of confidential commercial information and personal data, access to documents submitted in support of marketing applications would be denied only in limited circumstances. Since then, the report says, EMA has released more than two million pages of regulatory documents, including clinical study reports, that previously would have been considered confidential.
In its 2016 release for the two drugs, EMA provided some 260,000 pages of detailed clinical trial information, including the protocol, statistical analysis, and detailed clinical data. Some information was redacted to protect patient privacy, but EMA considered only two pages to contain “confidential commercial information,” the authors say.
An EMA policy adopted in 2014 allows online publication of all clinical study reports in connection with a marketing authorization application submitted after 1/1/15 and after the application has been approved, denied, or withdrawn. That policy could be affected by a legal challenge before the European Union General Court dealing with a specific Phase 2 study report.
As the issue plays out in the European Union, the authors write, the challenge FDA must confront “is that the clinical study reports submitted in support of drug marketing applications in the United States are basically the same as in the European Union. FDA currently considers clinical data to be confidential commercial information, whereas the EMA does not. The EMA’s policy, if it survives the current legal case, could lead to the anomaly that the EMA proactively publishes clinical study reports online (after decisions are made regarding marketing authorization applications) whereas FDA withholds the same or similar clinical study reports. Despite the importance of this issue to public health, in neither the United States nor the European Union is there yet clear legal authority on whether clinical study reports should be made public and, if so, under what conditions.”
An FDA 2010 Transparency Task Force report called for a “broader discussion of the issue with relevant stakeholders.” The article concludes that although there is no evidence that the release of clinical study reports by the EMA has improved the science of drug discovery and regulation, or reduced drug cost, such a discussion has not yet taken place in a substantive way, but it should and soon. “If the clinical study reports are published on the EMA Web site,” it says, “then the FDA position may be undermined. This would be an unfortunate result for FDA, the global leader in drug evaluation and regulation.”