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Risks posed by fast tracking the approval of prescription drugs


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President Trump has recently been pressuring the Food and Drug Administration (FDA) to speed up the drug approval process so that critically ill patients will be given a better chance to survive. His opponents argue that speeding up the drug approval process may be far less beneficial for patients and could cause significant harm instead.

A study, recently conducted by Yale Medical School, highlights how they found that at least 33 percent of all prescription drugs that were placed on the market between 2001 and 2010 posed significant risks for patients.

During the first decade of the century, 71 of the 222 drugs that were approved by the FDA were ultimately removed from the market at some point. In other cases, they were able to stay on the market, but a large majority later had to add “black box” warning labels. These generally warn patients of known side effects or risks posed by taking a drug.

With the drugs that were ultimately recalled or had black box warnings placed on them, researchers found that this only occurred after more than four years had passed since it was first introduced to the market. The types of drugs most often recalled during this time frame included biologic and psychiatric ones.

Researchers from Yale also found that the drugs most often affected by recalls or delayed warnings were those that had been put on the fast track to approval. Just days prior to leaving office, President Obama authorized the implementation of the 21st Century Cures Act. It gave drug manufacturers an ability to petition the FDA for approval of their drug based on evidence outside of three-part clinical trials.

While most researchers note that the FDA could stand to improve its efficiency, they note that the lack of thorough testing of drugs is an enormous safety issue. They maintain that many patients perceive an original drug approval as meaning that it has been tested and is safe.

Even if a drug manufacturer or medical device maker do find their products to be defective, they are only subject to voluntarily reporting of these issues. Not being required to do so puts countless patients at risk.

If your health has declined or you’ve lost a loved one after taking a dangerous drug, then you may benefit from discussing legal options available to you with a defective drug attorney.

Source: NPR, “One-third of new drugs had safety problems after FDA approval,” Sydney Lupkin, accessed Sep. 29, 2017

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