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John Bisnar
John Bisnar
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Improved Drug Safety Promised By FDA

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The Food and Drug Administration is now proposing steps to improve the safety of prescription medication after years of criticism of its drug safety standards and the much-publicized Vioxx scandal.

The new steps are designed to make sure concerns about potential drug safety are widely circulated within the agency before a drug is given the stamp of approval, according to an article in www.consumeraffairs.org,

According to Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs,

“Our ongoing assessment of the drug and medical product safety system has affirmed that it is essential that our processes and scientific methods keep pace with the rapid evolution of science, technology and the health care system. The extensive input we have received from stakeholders has proven invaluable as we transform the drug and medical product safety system and continue to fulfill our mission to protect and promote the public health.”

Various consumer advocate groups have long criticized the FDA saying that the agency has been partial to the needs and wants of drug manufacturers rather than protecting consumers. The agency’s officials have vigorously denied the claim. As evidenced by the Vioxx debacle involving the giant pharmaceutical company Merck, which has been the most serious case affection tens of thousands of consumers nationwide, some drugs do receive a fast track approval process and are used by millions of consumers before problems are detected or uncovered.

Vioxx received FDA approval via the fast track process and became one of Merck’s biggest moneymakers before the company voluntarily withdrew it from the market in September 2004. That action was prompted by the disclosure that use of the drug increased the risk of heart attacks and strokes. The pharmaceutical giant faces thousands of lawsuits from consumers who claim Merck knew of the problems for years before pulling Vioxx from the market. BisnarIChase is pursuing a large number of Vioxx cases which are head to trial since Merck denies any responsibility and refuses to settle their cases.

The FDA said, in setting out new steps it is responding to a set of recommendations made by the Institute of Medicine, released in September 2006. The FDA said it carefully considered recent IOM recommendations, along with advice from other experts, for making needed advances in the system. The agency said it agrees with the IOM that FDA’s mission requires the agency “to balance expeditious access to drugs with concerns for safety.”

Although it is a relief that the FDA is doing something about strengthening its approval process, much damage has been done. Vioxx has already contributed to hundreds of thousands of deaths. Let’s hope that catastrophic debacles of this nature don’t repeat and that the FDA learns from its mistakes and puts American consumer safety over foreign and domestic drug maker profits.

If you or a loved one has suffered the effects of Vioxx or other defective drugs, we may be able to help. Contact us for a consultation.