Statement on the U.S. Senate vote of the 2012 Food and Drug Administration Safety and Innovation Act

Statement of Diane E. Brown, Executive Director

Arizona PIRG

The U.S. Senate moved rapidly toward passage of a five-year user fee reauthorization for the Food and Drug Administration on Thursday, with strong bipartisan support. We commend the Senate for agreeing to provide deadlines for the issuance of certain regulations and to require a GAO report on the implementation of the clinical trial registration and reporting requirements under the Public Health Service Act. This will ensure pharmaceutical and medical device companies are accountable and provide more information about their clinical trials, thereby ensuring greater safety for consumers.

However we are disappointed that key amendments Arizona PIRG supported that would have protected consumers from the deceitful practices of the pharmaceutical industry and give greater access to affordable generic drugs did not pass.

The Senate bill also passed without making adequate progress in preventing unsafe devices from entering the market. This is of great concern in view of the 1/2 billion recall of medical devices during 2010 and 2011.

As the House readies itself for reauthorization H.R.565, their version of this bill, Arizona PIRG will be advocating on behalf of consumers to ensure that the medical devices and drug review process is strengthened.