STATMENT: US Senate Approves FDA Safety and Innovation Act

The US Senate Passage of the Prescription Drug User Fee Act (PDUFA) not Strong Enough to Ensure Sufficient Consumer Safety from Drugs and Medical devices.

Jon Fox

Statement of Jon Fox, CALPIRG Consumer Advocate, on the US Senate vote of the 2012 Food and Drug Administration Safety and Innovation Act:

The US 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 include Senator Grassley’s amendment 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 U.S. PIRG supported introduced by Senator Sanders, and Senator Bingaman 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 to us in view of the 1/2 billion recall of medical devices during 2010 and 2011 and the death of a toddler fatally infected by a contaminated  medical swab in December 2010.

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

Jon Fox, Consumer Advocate
Office: (415) 622 0039 x309
[email protected]

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The California Public Interest Research Group (CALPIRG) is a result-oriented public interest group that protects consumers, encourages a fair sustainable economy, and fosters responsive democratic governance. CALPIRG is a member of U.S. PIRG, the federation of state Public Interest Research Groups.


Jon Fox