FDA Approves 41 New Medicines in 2014, the Most Since 1996

The Food and Drug Administration (FDA) approved 41 new medicines in 2014, the most since 1996, when the agency approved a record 53. FDA approved 27 in 2013. The jump can be attributed to many new drugs for orphan diseases, which are rare conditions and disorders that affect fewer than 200,000 people in the U.S.  The spike in approvals is notable for a number of reasons. For one, the pharmaceutical industry as a whole has been bouncing back from a number of patent losses on big name products over the last couple of years—the so-called patent cliff. While a number of large companies indeed will face stiff generic competition, the 2014 new drug approval numbers shows that innovation has not slowed down.  Another thing that makes the spike in approvals somewhat surprising is the backlash the agency experienced earlier this year over its approval of Zohydro, a powerful pain medication. It was perhaps expected that the FDA would be overly restrictive to avoid a future uproar. In October, FDA responded to the criticism, defending its approval.  The 18-year high in drug approvals also reflects the pharmaceutical industry's ongoing shift toward specialty drugs for niche conditions, which often come with extra exclusivity protections (7 years), streamlined approvals, and higher prices. With almost 40 percent of the new drugs for treating rare diseases, it is not unusual for annual costs per patient to reach more than $100,000, Reuters reports.  The Ame...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs