Recently, it has been noted that the Food & Drug Administration (FDA) is speeding up its review process for new drugs. This process allows for more drugs to enter the market, allowing for people to have access to an abundance of new medications to help their ailments. However, according to this article published to The Big Story, there have also been concerns about whether the FDA is failing to keep up with safety issues with those medications once they reach patients.
There has been a new Government Accountability Office (GAO) report outlining the shortcomings of the FDA’s new system for tracking drug safety issues, including incomplete, outdated, and inaccurate information. In addition, the FDA is employing the use of mechanics to streamline the review process for drugs that treat deadly diseases, like cancer. FDA leaders have even been boasting about how quickly and efficiently scientists can approve experimental drugs, thus speeding the drugs’ path to market.
In 2015, there were 45 drugs that were the first of their kind approved to go to market, the highest number in 19 years. Additionally, the GAO found that the FDA has been late in reviewing more than half of the 1400 follow-up studies it had requested or required of drug-makers between 2008 and fall 2013. These studies are crucial to spotting safety issues that may not emerge until patients start taking the drugs.
The report has also clearly highlighted that the FDA is not performing its due diligence in tracking drug safety issues and post-market studies that are crucial in ensuring patient safety. The GAO also found that a quarter of all drug applications approved by the FDA used at least one pathway to speed review, based on data collected from late 2006 to 2015.
Overall, what does this mean to the consumer? It means that new, recently-added drugs on the market could pose a greater threat to those that take them. The drugs are not going through as tedious and detailed of a review process to determine if the drug is safe for mass consumption. This opens up the consumer to the unknown dangers and side effects of the drug.
If you’re looking for a Philadelphia dangerous drugs law firm, Villari, Brandes, & Giannone is your first choice. Our experienced attorneys have both a track record of success and are always available to answer your questions and address your concerns. So if you or a loved one have suffered from the negative effects of the FDA’s oversights, be sure to call Villari, Brandes, & Giannone by visiting our website or calling 888-729-2901 today!