LA VERNE, Calif.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.
Lead researcher Dr. Gary Lawson said: The drug manufacturers are now paying for and receiving reduced regulatory oversight, special consideration, unique opportunities and unprecedented U.S. monopoly protection. At minimum, the FDAs dependence on drug industry funding creates doubt and suspicion as to the agencys motives, and at maximum, Americans who take a brand-name prescription drug may be doing so at their own peril.
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 FDAs 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 percent 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 industrys U.S. monopoly. 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.
Lawson said: The FDA taking drug industry money is failed public policy. In exchange for saving taxpayers a few cents a month, U.S. citizens have increasingly become the worlds guinea pigs by testing newly released medications. An unethical partnership was created between the regulated and regulators. Regarding prescription drugs, U.S. citizens can no longer trust the FDA. Known deadly medications are given FDA approval. Few new breakthrough medications have been produced, and the well-being of Americans by the tens of millions have been jeopardized.
The ULV study listed the following four major findings:
1. Taking drug industry money negatively impacts the FDAs primary mission of protecting the health and safety of U.S. citizens. Therefore, Congress must immediately eliminate private industry fees paid directly to the FDA or eliminate the pro-drug industry strings attached to the money.
2. Since the FDA started collecting drug industry money, the Agency has made changes that support the profit motives of the brand-name drug industry and put Americans at risk.
3. Drug industry money impedes the FDAs ability to maintain the public trust, and compromises the Agencys continued legitimacy as a viable, objective, consumer protection agency.
4. Congress must create an independent, objective, consumer protection medication safety agency.
Based on a review of the findings of this important study, Dr. Suzanne Holmes, faculty, School of Human Service, Capella University, said: U.S. citizens by the millions are taking newly released medicines and experiencing unintended, sometimes deadly, adverse drug reactions. Not only has the FDA abandoned its primary role of protecting American citizens, it is now supporting the brand name pharmaceutical industry in such a manner that the Agency has become, in essence, another well-paid marketing arm.
For more information, see www.FDAStudy.com.
From the May 4-10, 2005, issue