3 things to know about 2016 drug approvals

In 2016, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 22 new medicines to treat a broad range of illnesses for patients in need. These much-needed new treatments include medicines for multiple sclerosis, chronic lymphocytic leukemia, ovarian and bladder cancer and the very rare spinal muscular atrophy (SMA).

Among these new medicines, more than a third are treatments for rare diseases and more than one-third are first-in-class, meaning they use a new, unique approach to treating an illness that has never before been available.

While some news headlines have focused on the number of approvals in 2016, the complete picture on what’s going on in biopharmaceutical research is more complex. Here are 3 things you need to know about research and development of new medicines by America’s biopharmaceutical research companies:

1. The number of FDA approvals has been on the rise overall in recent years
   While FDA approvals naturally ebb and flow each year, it’s important to step back and look at the continued innovation ongoing in biopharmaceutical research. FDA’s CDER has approved 225 drugs just since 2010. Recent new approvals are among the most innovative medicines ever developed taking new approaches to diseases from cancer to cystic fibrosis.
   
   
2. As the science becomes more complex, the research becomes more challenging
   Because of the complicated nature of human diseases, the research and development process is often arduous. The average time to develop a new medicine is more than 10 years, and only 12 percent of medicines that enter clinical trials will make it to patients. While the science to find new medicines is only getting harder, America’s biopharmaceutical researchers and scientists are continually working to improve the process of drug development to keep pace with the cutting edge science.
   
   
3. There is tremendous promise in the research pipeline
   Despite these challenges, the current research pipeline shows that the future of biopharmaceutical innovation has never been more promising for patients in need. Today, across the globe there are currently more than 7,000 medicines in development, of which more than 1,700 are in phase III trials – meaning they are in late-stage studies. Some of these are existing medicines which companies are studying to benefit different patient populations, and many are completely new medicines and approaches to treating illness.

Modernizing the FDA and efforts like the reauthorization of the Prescription Drug User Fee Act will continue to support research, development and timely approvals for new medicines.

To learn more about the research and development process, click here.