Last year, the Food and Drugs Administration (FDA) approval rate for new drugs dropped to an all time low of 22 compared to 45 in 2015. It is the lowest approval rate for new drugs since 2010.
In Europe, the European Medicines Agency (EMA) approved 81 new prescriptions compared to 93 in 2015. The only difference between FDA and EMA is that latter also recommends generic drugs.
The sudden decline is worrying for the pharmaceutical research industry. One of the reasons for the decrease of approvals according to experts is due to less applications for new drugs filed by pharmaceutical companies last year.
Additionally, five new drugs were approved in 2015 when they were supposed to be scheduled for 2016.
According to the Times of Malta, the slowdown may suggest that pharmaceutical researchers are going back to more normal levels of productivity. There was a spike in FDA approval rate for new medicines in 2014 and 2015 which was the highest in 19 years.
John Jenkins, the FDA director of the office of new drugs says that this trend should not cause any alarm as dozens of drugs are scheduled for approval in 2017. One of the most anticipated drugs yet to be approved is Roche's multiple sclerosis therapy Ocrevus.
Another drug in line for approval is Sanofi and Regeneron's sarilumab for rheumatoid arthritis, the Perf Science reports.
The majority of pharmaceutical executives is optimistic despite the new report. They cite the hunt for new medicines for cancer as potential money makers. They believe it is easy to achieve such goal given the new advances of technology and improved understanding of diseases.
However, these new developments are not enough to guarantee an increase of new drugs in the market. The FDA approval system is a tough nut to crack and returns on research and development are not necessarily lucrative.
Additionally, pharmaceutical companies have to deal with unfavorable situations as reported earlier.
Given the upbeat responses of analysts and industry executives, the low FDA approval rate for new drugs last year may not really be as bad as it looks.
