Industry Influence on Drug and Medical Device Safety at FDA

The report examines the influence of the pharmaceutical, biotechnology, and medical device industries on the US Food and Drug Administration (FDA) through lobbying and political contributions. It highlights that between 2009 and 2011, these industries spent over $700 million on lobbying and provided millions in targeted campaign contributions to key lawmakers. The author contends that this financial influence is driving legislative efforts to roll back 2007 reforms, potentially by adding job creation to the FDA's mission, reducing medical device scrutiny, and relaxing financial conflict-of-interest standards for scientific advisory committees.

• Between January 1, 2009, and December 31, 2011, the pharmaceutical, biotechnology, and medical device industries and their trade associations spent more than $700 million lobbying the US Congress and Administration. Of this total, drug companies and their associations spent over $487 million, biotechnology companies spent $126 million, and medical device companies spent $86 million.
• From 2009 through 2011, these three industries targeted nearly $6.3 million in campaign contributions to 70 lawmakers on key legislative committees overseeing drug and medical device safety. Specifically, more than $4.4 million was given to members of the House health subcommittee and the Senate HELP committee during the 2009-2010 cycle, followed by more than $1.8 million in 2011.
• Current bipartisan legislative proposals seek to weaken the FDA's authority by potentially adding job creation to its mission, reducing the scrutiny of medical devices via 'least burdensome' alternatives, and eroding the 'substantial evidence' standard for reviewing drugs and devices.
• Industry representatives from PhRMA and BIO have advocated for relaxing financial conflict-of-interest standards for FDA scientific advisory committees, arguing that current rules create barriers to recruiting qualified advisors. However, FDA Commissioner Margaret Hamburg testified that these standards have not created problems for the agency.
• The Food and Drug Administration Amendments Act (FDAAA) of 2007 established requirements to reduce the number of waivers granted to conflicted experts by 5 percent annually over five years, publicly disclose the names and conflicts of experts receiving waivers, and increase the recruitment of non-conflicted experts.

APA

Union of Concerned Scientists (2012). Industry Influence on Drug and Medical Device Safety at FDA. https://www.ucs.org/sites/default/files/legacy/assets/documents/scientific_integrity/industry-influence-drug-medical-device-safety-FDA.pdf

Chicago

Union of Concerned Scientists. Industry Influence on Drug and Medical Device Safety at FDA. 2012. https://www.ucs.org/sites/default/files/legacy/assets/documents/scientific_integrity/industry-influence-drug-medical-device-safety-FDA.pdf.

Wikipedia

{{cite report |author=Union of Concerned Scientists |title=Industry Influence on Drug and Medical Device Safety at FDA |date=29 March 2012 |url=https://www.ucs.org/sites/default/files/legacy/assets/documents/scientific_integrity/industry-influence-drug-medical-device-safety-FDA.pdf |access-date=23 October 2026 |via=Climate Insights Directory}}

BibTeX

@techreport{unionofconcernedscientists2012industry, author = {{Union of Concerned Scientists}}, title = {{Industry Influence on Drug and Medical Device Safety at FDA}}, institution = {Union of Concerned Scientists}, year = {2012}, month = mar, url = {https://www.ucs.org/sites/default/files/legacy/assets/documents/scientific_integrity/industry-influence-drug-medical-device-safety-FDA.pdf}, urldate = {2026-10-23}, note = {Indexed by Climate Insights Directory} }