A 2005 University of La Verne (ULV) School of Public Administration study concluded that the large sums of money paid yearly to the Food and Drug Administration (FDA) by the brand name pharmaceutical manufacturers gives the drug industry financial leverage and influence over the FDA. Until the drug industry money or the strings attached to the money are eliminated, U.S. citizens should be extremely cautious and highly suspicious of FDA actions related to prescription drugs.

In 1992, to speed up new drug approvals and eliminate a backlog of needed life-saving medications, Congress authorized the collection of drug industry fees for one five-year period. Although no new drug approval efficiencies were realized after year five, the law was extended twice. According to the ULV study, with each extension, the drug industry paid significantly higher fees, and then, used the higher fees as leverage to limit the FDA’s ability to act as an objective consumer protection agency.

As the brand name drug industry acquired more financial leverage over the FDA, the ULV study showed that adverse drug reaction reports more than doubled. Americans have a 32% higher chance of experiencing a reportable adverse drug reaction. More deadly drugs were released in the U.S. first and stayed on the U.S. market longer. The costs of drugs to consumers skyrocketed. The FDA shifted its policy to protect the drug industry’s U.S. monopoly, and actively worked toward stopping the flow of lower cost Canadian medications. Off-label drug promotion was authorized. Direct to consumer advertising was authorized. The FDA significantly decreased other consumer protection services, and the FDA allowed the drug industry to set internal Agency objectives, goals, and FDA job descriptions.

For more information see www.FDAStudy.com.


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