Public availability of information

Provides for public availability of information in substantially the same manner and to the same degree as the federal program. 

The results of clinical trials conducted under an IND have traditionally been regarded as confidential business information that FDA was prohibited from releasing to the public under the Freedom of Information Act and that the publication of which was determined solely by the drug sponsor. The Food and Drug Administration Modernization Act of 1997 established a clinical trial data bank for drugs for serious or life-threatening disease and required the inclusion of information on all effectiveness trials for these drugs. As a result of widespread concern about the lack of public availability of information about all clinical trials and their results, individual companies and the Pharmaceutical Research and Manufacturers of America have... 

The two most contentious aspects of REACH have been the registration requirements and the authorization process. While no one has argued that substances should not have to be registered, there have been many arguments about the amount of data that must be submitted in the registration dossiers and about how to deal with substances contained in manufactured articles imported from outside the EU. The public availability of information has also been an issue. The focus of the debate about authorization was whether authorizations should be granted where an alternative was available. The debate here can be seen as an argument between risk-based and precautionary approaches. 

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