Food and Drug Administration (FDA) drug approvals in 2015 have risen to record levels. They have been helped by the approval of new drugs for conditions and diseases that did not have a treatment or cure before, a particular class of drugs referred to as first-of-a-kind drugs. The number of drugs belonging to this category approved in 2015 was 45, the highest number of approvals for such drugs since 1996.
What an analysis of the numbers also discloses is that between 2007 and 2011, one in 19 drugs that underwent initial testing came to finally obtain an approval. Today, that number has improved significantly to one in 13 drugs. However, some other parameters have weakened in recent years. In the 1990s, it took a proposed drug an average of 11 years to finally be approved from the time that it was first tested. Today, this duration has gone up to 14 years, according to the Chicago Tribune.
The new varieties of drugs that have been approved by the FDA in the past year include treatments for hepatitis C, breast cancer and cystic fibrosis. Several of these treatments are virtually unique and there are very few comparable drugs or treatments for such conditions anywhere in the world, according to the New York Times.
But the prices of such drugs when they hit the market tend to be on the higher side. For instance, Ibrance, the new breast cancer drug released by Pfizer, costs $118,200 for one year's supply. Similarly, the cystic fibrosis treatment Orkambi - developed by Vertex Pharmaceuticals - costs $259,000 for one year. The high prices of prescription drugs continues to remain an election issue and politicians such as Bernie Sanders and Hillary Clinton have said that they would like to see a decrease in these prices, according to the Salt Lake Tribune.
The number of approvals given by the FDA is a reflection on the efficiency of the state regulator in processing promising candidate drugs through a rigorous and fair process for their eventual approval and distribution. This number also tells us a great deal about the extent to which pharmaceutical companies are doing truly innovative drug designing that alleviates suffering.
