The Pay-To-Play Scandal

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The 1990s and the Prescription Drug User Fee Act brought an era of shorter drug review times, larger FDA agency budgets, and more staffers. By 1999, the median drug review time was less than twelve months and six months for priority drugs. However, patient advocates and those who were more concerned with Type II errors and the passage of unsafe pharmaceuticals were apprehensive about this new trend of loose regulation and repeatedly pointed out the increase in drug recalls. The financial relationship established between the industry and the agency by the PDFUA cast doubt on the impartiality of the review process leading to drug recall scandals such as the Vioxx scandal of 2004, where a drug used to treat arthritis remained on the market long…show more content…
Another striking example of this regulatory failure and the unethical outcomes of regulatory capture is the use of trade secret laws to benefit drug companies and help them minimize, deny, or hide adverse effects of their products. The lack of transparency in the drug approval process is highlighted by the use of trade secret laws, which are successful at hiding unflattering drug trial data or reports of dangerous side effects even against the Freedom of Information Act by classifying them as “trade secrets” instead of necessary information for consumers. In the private sector, trade secret laws are a fundamental protection to drive investment and economic growth, however, when interpreted generously, this law protects all the data collected during the innovative period of drug manufacturing, including the results of some trials or side effect reporting, from anyone outside the company. Supporters of this interpretation of the Freedom of Information Act claim that failed efforts at drug development need protection to ensure that the developers are not at a “competitive disadvantage.” However, when the same drug can be disapproved for one use but approved for another, this data is still relevant to public health, yet is locked up by the FDA. This was the case for the Eli Lilly drug Yentreve, a drug that was disapproved for treating stress urinary incontinence due to data showing its connection to suicide rate increases, but approved under the name Cymbalta to treat depression. According to the FDA, federal regulation prohibits them from releasing study data for a drug that failed to gain FDA approval, even if the same drug under a different name, is on the market. With so much data off-limits, it is hard to account for other cases such as this but many private researchers point to pain reliever Bextra, manufactured by the
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