FDA Takes Shortcuts, Endangers Americans’ Health
By: Cohen, Placitella & Roth @ May 03, 2016
The U.S. Food and Drug Administration (FDA) is responsible for the oversight of prescription and over-the-counter drugs in the United States. Before a new drug can be introduced to the public, the FDA must approve it. The approval process includes conducting clinical trials, and a complex application process. Further, once the drug makes it to market, it is also the responsibility of the FDA to monitor any problems with that drug and the drug’s safety. A recent review of the FDA’s management of these tasks, conducted by investigators from the Government Accountability Office, returned a conclusion that that raises questions about the agency’s effectiveness.
FDA Data Incomplete and Out of Date
According to a recent article published in The New York Times, data kept by the FDA regarding the post-market safety data of drugs was found to be “incomplete, outdated, to contain inaccuracies, and to be stored in a manner that made routine, systematic analysis difficult.”
A Fast-Track System That May Put Americans at Risk
In addition to the above concerns, worries about the FDA’s ‘fast-track’ system were also brought to the table. Critics argue that the fast-track system allows pharmaceutical companies the ability to delay the release of evidence regarding the long-term safety and effectiveness of a drug until after it has already been released to market. In other words, hundreds of patients may use a drug before long-term effects of the drug are understood. Proponents of the fast-track system, on the other hand, say that the fast-track system does not pose risks and is necessary due to the constant evolutions of science.
Failure to Track Safety Issues
Finally, the report conducted by the Government Accountability Office found that when a safety issue is identified by the FDA, the safety issues are often not tracked in the FDA’s computer system. The reason, according to the agency, is that the computer system is “cumbersome.” Another reason, according to the article in The Times, is that a policy change within the agency has made entering data more difficult.
The Importance of Effective Drug Tracking
When drugs are not properly tested before being released to market, and when drugs that are on the market are not properly monitored for safety issues, people’s lives are put at risk. Dangerous and defective pharmaceuticals cause injuries to hundreds of people every year throughout the United States – the FDA should do its job to mitigate potential harm by operating more effectively.
When a Dangerous Drug Causes You Harm
If a dangerous or prescription drug harms you, you are not at fault, and you deserve to be compensated for any harm that you have suffered. At the law firm of Cohen, Placitella & Roth, P.C., our experienced defective pharmaceutical attorneys, serving New Jersey and Pennsylvania, will advocate for you! We will help you to get to the bottom of who is to blame (often the manufacturer of the pharmaceutical), how to file a claim, what damages you may be entitled to, and more. To schedule your free case consultation with our attorneys today, contact us using our online form or by calling our offices directly at (215) 567-3500.