In 2009, it took the FDA an average of 21 months to approve a new drug for market. By 2015, the process was down to 10 months, with drugs meant to treat infectious disease, rare diseases and cancer getting okayed the fastest.
A big reason for this dramatic shortening of the process is a provision of the 2012 Food and Drug Administration Safety and Innovation Act that allowed the FDA to apply a “Breakthrough Therapy Designation” to certain submissions. Once designated a “breakthrough therapy,” a drug’s review timeline can be as brief as 60 days. Such breakthroughs come most often in the oncology, infectious disease and rare disease fields.
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This may sound like good news. After all, the less time a promising new medication spends under FDA scrutiny, the sooner doctors can start prescribing them to patients. But there is a potential flip side: the less time the FDA spends testing a medication, the more likely that problems with the drug slip through the cracks.
This could lead to patients experiencing unexpected reactions and side effects, putting their health at serious risk. In the worst cases, patients can die when a defective drug gets FDA approval.
For people injured by a poorly designed or mislabeled medication, taking on a pharmaceutical company can seem daunting, but an experienced product liability attorney can help level the playing field.