FDA DRUG REVIEWS NOT TRANSPARENT ENOUGH, ACTIVISTS SAY

The FDA does not do a good enough job in making drug development information available to the public, and proposals for clinical-trial registries do not go far enough to address this problem, the activist group Public Citizen said in a study published in the Duke Law Journal.

The agency is too closely aligned with industry and tends to shield industry data from the public during the drug development process, the group said in the article, "Sometimes the Silence Can be Like The Thunder: Access to Pharmaceutical Data at The FDA." For example, the FDA has fought Public Citizen and other groups' efforts to obtain data about new drug applications, advisory board members' conflicts of interest, Phase IV study protocols and other information, the article said.

While there needs to be more transparency, the current proposals for a clinical trial registry "would leave many forms of data-withholding intact." Current proposals call for companies to register their studies when the study begins and disclose the results when the study is completed.

Instead, the agency must provide the results of these studies as they become available, the article said. The registries must also be mandatory, and failure to disclose this data should be punishable by financial penalties and other punishments, the group added.

The report is available at www.citizen.org/publications/release.cfm?ID=7475#F28 (http://www.citizen.org/publications/release.cfm?ID=7475#F28).