FDA Drug and Biologic Approval at All Time High
[Posted on: Thursday, 04 February, 2016]

In the year 2015, FDA approved the largest number of new drugs and biologics ever; 45 new drugs and biologics were approved. One third or 36% of these new products were first in class drugs meaning that they had novel mechanisms of action and were chemically and biologically different from any drugs approved in the past. More interesting the rate of approval; every single NDA or BLA application filed with the Agency was approved within a year indicating one of the highest success rates for marketing approval applications for two years in a row. In 2014, also FDA approved all the 41 applications it received. Another interesting trend is that about half (47%) of the new products approved are for orphan indications. This was also a bonanza year for breakthrough drugs, 10 of which got approval from FDA based on preliminary clinical data making the drugs available in the market based on much shorter clinical and non-clinical development time, and associated cost. Interestingly, more than half of the applications (53%) were approved under the priority review process, i.e., they were reviewed in 6 months instead of the standard 10 months. FDA met its review time-lines 96% of the times, and 87% of the drugs approved in the US were the first approval for those drugs anywhere in the World. The report from FDA touts the success of FDASIA and FDA’s improved review systems and indicates the aggressiveness on FDA’s part of provides speedy review and positive decisions for most of the applications it received. The rate of drugs approved under the 505(b)(2) regulatory pathway remains identical to previous years. FDA approved about 70 new drugs via the 505(b)(2) pathway, similar to the 64 approve under this pathway last year. The 505(b)(2) drugs remain about two-thirds of all new drugs approved by FDA. It has been speculated if the FDA’s increased aggressiveness to approve everything it gets will lead to compromises in the quality of review. However, the increased rate of approval is mostly due to the increased number of innovative programs at FDA such as breakthrough therapy designation and priority review process. It can be argued that the regulatory environment has become quite favorable to the drug industry. An equally fair assessment is that the industry has become smarter in dealing with the regulators. On a different note, one can argue that the cost of bringing a drug to market these days is much lower than the published estimates. It is obvious that the drugs getting approval via the breakthrough pathway cost must less to get to market than the traditional drugs developed with the one billion plus development budget. Also, novel drugs mean that many of these new approvals come with long patent life giving the developers much longer time to recoup their investment. In the current environment of drug pricing debate, it is imperative that one would evaluate the price of these new drugs in the light of the current regulatory paradigm and make a case of fairness of prices of these new life-saving drugs.