ClickCease GAO Says FDA Lacking in Developing Drug Surveillance Office
12/09/09   |   By

GAO Says FDA Lacking in Developing Drug Surveillance Office | DC Metro Area Medical Malpractice Law Blog

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 Posted by: Salvatore J. Zambri, founding partner

The Associated Press has reported today that the Food and Drug Administration (FDA) “still hasn’t restructured its staff to better monitor drug safety, more than three years after experts recommended key changes in the wake of the Vioxx scandal.”  According to the report, the Government Accountability Office (GAO) will release a report today indicating that FDA officials “have made some changes to drug oversight,” although the agency “continues to give the bulk of its decision-making power to scientists who approve new drugs, rather than those who monitor the side effects of drugs on the market.”  Consequently, the GAO “calls on the FDA to set a timetable for transferring new responsibilities to the surveillance office.”

In response, the FDA “said major decisions about drug safety are delegated to the new drugs division because that is ‘where staff with the broadest expertise and experience’ on product safety issues reside,” according to the AP report.

We urge the FDA to ramp up its surveillance of drugs, and we implore pharmaceutical companies to be sure their products are safe before placing them into the marketplace.  Drugs are obviously important, but manufacturers need to put people over profits.  No drug should enter the marketplace until it has been thoroughly tested and until its side-effects are fully understood.

Before taking any medication, please confer with your doctor.  Know all risks and benefits of a drug before taking it.

We wish you good health.

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a “Big Gun” and among the “top 1%” of all lawyers in the Washington metropolitan area.  The magazine also describes him as “one of Washington’s best–most honest and effective lawyers” who dedicates his practice to catastrophic personal injury matters, including medical malpractice actions stemming from defective or dangerous medications.   He has also been named a “DC Super Lawyer” by Super Lawyer magazine (March/April 2009)–a national publication that honors the top lawyers in America.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you want more information about your legal rights, please email Mr. Zambri at [email protected] or call him at 202-822-1899.

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