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FDA Claims It Spends as Much Time Surveilling Drugs after Approval as Before Approval

May 9, 2012 By Diseases & Conditions

Many drug side effects and risks are known as soon as a drug hit the market. Look at any of those minute long commercials where the risks take up the last half of the commercial, and you have a good idea of what goes onto the box. However, there are many drugs whose side effects are either unknown or hushed up prior to approval. Only the drug company and their government cohorts, the Food and Drug Administration may know about it – or they consider the risk such an outlier that it is unlikely more than a few people will get sick.

To be fair, the FDA says it requires companies to perform post-market studies and to change labels when needed, but critics contend post-market surveillance of drugs that may be dangerous is not really what the FDA is interested in doing. Before 2008, the agency had little recourse but to urge drug companies to voluntarily change labels or conduct further safety trials. The FDA was given more outright authority after the Obama administration stressed regulation for an industry that many people saw as caring much more about the bottom line than the people who needed to take the drugs for their health.

Now the FDA is responding to critics by publicly stating they spend just as much time in the post-approval process of potential drugs as they do in the pre-approval process. According to director of the FDA’s Center for Drug Evaluation and Research, Dr. Janet Woodcock, this approach is now more “balanced.”

When a company is found to be in violation, the agency will fine them for failure to do things like conduct safety trials, change labeling, or even pull the drug from the market if necessary. However, critics contend the FDA often does not follow through with penalties as they should.

The example used is the smoking cessation drug called Chantrix. In 2008, the FDA started using a computer program called Sentinel, which was launched to help track and identify drug and medical devices already on the market that were having problems. This was done so that the FDA could go beyond simply relying on companies and patients giving voluntary reports of side effects.

Sentinel was used to see if there were any negative side effects with Chantrix, but could not find any. However, researchers in the US said Chantrix “carried too many risks,” such as depression, and that it should only be used when absolutely necessary. Pfizer, the maker of Chantrix, balked and said the findings were flawed because the FDA said the drug was OK. The FDA also said the findings were flawed because the sample size was too small and only looked at cases of Chantrix users winding up in psychiatric wards.

So, in the end, we may have an FDA that added a computer program to help track risky drugs, but they will still side with the drug industry when it suits them.

If you or a loved one has become seriously ill due to a defective drug, don’t tell the FDA, but contact an experienced drug injury attorney in your area today.

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Filed Under: Chantrix

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