Survey: Despite Progress, FDA Scientists Feel Political and Industry Pressure

Mar 14th, 2012 | By | Category: FDA

March 7, 2012 ~ The Union of Concerned Scientists (USC) issued the results of a survey released today of 977 Food and Drug Administration scientists. They were asked about the pressure they feel to approve drugs and medical devices – can they communicate candidly with the public? – can they publish their results? -  is there corporate influence over regulatory decisions?

The problems are systemic within the agency which oversees the safety of consumer products such as food, drugs and medical devices that equal 25 cents of every dollar spent by Americans.

The group conducted a similar survey in 2006 which asked many of the same 33 questions. This time around UCS says there is some progress toward restoring scientific integrity to the FDA’s decision making. Scientists in 2011 also had more respect for the leadership than respondents in 2006.

However interference persisted with 40 percent of respondents feeling business had an influence over FDA decisions and 55 percent felt politics tainted their work. More than one-third felt their work had been subjected to interference over the last year.

Here are some of the comments from scientists working within the FDA:

“We have to do too much with too little” – CBER Scientist

“No matter how well we do our job, it has to be realized that FDA is just one small part of a broken health care system in a society that embraces a culture of greed. Manufacturers have enormous incentive to selectively withhold evidence or lie outright about their products. Even when we know a manufacturer is gaming the system, it’s extremely difficult to prove malfeasance, so they get away with it, and it becomes the norm. We don’t have an integrity issue at FDA, It’s pervasive in our society. We are a shining beacon of integrity by comparison.”  – CDRH Scientist

“In the 1970′s there were ~800 people working on electroinic product radiation control issues. In 1983 that number dropped to ~400 people. Currently CDRH has less than 60 FTE’s working on radiological health issues and enforcement and the variety and number of non-medical electronic products continues to grow rapidly.”

– CDRH Scientist

“I realize that many times our hands are tied so we tread lightly. We are doing and injustice to public health by answering to the wrong masters. It seems as though every 4 to 8 years our mission changes. This is disruptive to our true mission. Get back to the basics, and appoint someone who will make changes for the public and no worry about political agendas.”

– ORA Scientist

Learn More

2011 Survey Responses
http://www.ucsusa.org/assets/documents/scientific_integrity/fda-2011-essay-excerpts.pdf

2011 Survey Data
http://www.ucsusa.org/assets/documents/scientific_integrity/fda-2011-detailed-survey-data.pdf

Press Release – Union of Concerned Scientists
http://www.ucsusa.org/scientific_integrity/abuses_of_science/fda-survey-shows-progress.html

 

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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.