News & Resources

January 4, 2010. Category: Product Liability, Unsafe Drugs, Unsafe Medical Devices

FDA Begins to Update Post-Market Procedures, Though Still Lacking

The Government Accountability Office (GAO) has compiled a report looking at the steps the FDA has been taking to improve communication between the internal offices of the FDA, in an effort to protect the public from dangerous drugs released on the U.S. market. The GAO found some FDA efforts towards this goal, including having done or planning to:

  • Improve communication between the Office of Surveillance and Epidemiology (OSE, once called Office of Drug Safety) and Office of New Drugs (OND).
  • In 2010, implement new data systems facilitating quicker access to outside data, in order to facilitate “timeliness, quality, and analysis of reports of adverse events associated with human drug use.”
  • Improve funding for private contracts to provide external data for speedier access.

But is this enough? Within the FDA, scientists in the OND are tasked with reviewing, and ultimately approving, new drug applications. These same scientists are also the ones who (generally) make the determination whether to pull the same drugs off the market. Meanwhile, the OSE monitors the drug’s side-effects on the market and compiles patient complaints. However, the OSE doesn’t have much say in whether the drugs should be pulled from the market. Many outsiders would point to this bureaucratic setup as improper – to have the same scientists which approved the drug also have to be the ones puts the public at risk.

Additionally, the GAO reports that both the OND and OSE are understaffed. Both offices’ employees cite the inability to meet their responsibilities. According to the GAO the OSE must double its employees in the next year in order to keep up with workload. All of this means that both the OND and OSE are understaffed and overworked; and as a result are unable to fulfill their responsibilities.

It’s important to remember that the GAO is fully independent of the FDA, the pharmaceutical industry, and trial lawyers. In fact, it’s an investigative arm of Congress, funded by taxes. There is no incentive for the GAO to fabricate or exaggerate in any direction, and their reports should be taken as truthful and honest. Knowing this makes their reports about the inadequacies of the FDA all the more alarming. While the GAO reports the FDA is going in the right direction, it still has a tremendous amount of ground to make up. And the FDA needs to do much more to distance itself from the pharmaceutical industry. And until this happens, some Americans are at risk of taking FDA-approved medications which should not be on the market.

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