Posted by Michael Wonder on 20 Feb 2017
The European Medicines Agency and publication of clinical study reports: a challenge for the US FDA
20 February 2017 - The US FDA has been the standard of drug regulation worldwide for decades.
In 1962, in response to the thalidomide tragedy, Congress directed the FDA to evaluate the effectiveness of drugs based on “adequate and well-controlled investigations, including clinical investigations” conducted by qualified experts.
Backed by this congressional enactment, the FDA crafted groundbreaking administrative regulations (eg, the requirements of a prespecified protocol, placebo or active controls, the phasing of clinical investigations, and informed consent from patients) that have guided the global clinical trial enterprise ever since. The FDA’s regulations revolutionised the evaluation of drugs in the United States and abroad.
However, the EMA, the counterpart to the FDA in the European Union, is poised to leapfrog ahead of the FDA in an equally important drug regulatory space of transparency. In October 2016, the EMA published on its website the clinical study reports for two medicines (carfilzomib and lesinurad) it recently approved. In so doing, the EMA enabled access to approximately 260 000 pages of detailed clinical trial information, including the protocol, statistical analysis, and detailed clinical data. Although some information was redacted to protect patient privacy, the EMA considered only two pages to contain “confidential commercial information.”
