FDA Approves Practically All Market Approval Applications These Days
[Posted on: Monday, August 27, 2015]
According to a new survey, FDA approved 96% of market approval applications it received in 2014, and so far in 2015. This is a sharp increase from the year 2008 and before when the approval rate was close to 50%. So, is this true to say the companies are more likely to succeed in getting their products approved by FDA whether they are new molecules or modifications of earlier molecules? Does it mean FDA has become lax in its review? Has FDA become less conservative? This survey came at an opportune time when it is a universal perception that FDA got strong-armed to approve the first female libido drug. On the face value, this may seem to show that FDA is more liberal in approving drugs than it was 10 years ago but that is probably not true. FDA has been frequently criticized for having a higher bar for approval, and for not approving products available in other countries. So how does this news fit the story? In the last 15 years, FDA has done an unprecedented job of increasing transparency and providing multiple avenues for companies to get timely and accurate feedback from the Agency. There are numerous processes for applicants to meet the review teams and discuss possible ways to address concerns from the reviewers. Meetings with the FDA have been proven to be one of the best tools available to well-prepared sponsors. Then there are hundreds of guidance documents released by FDA in the last 15 years providing detailed suggestions about solutions to potential problems providing one a key to the kingdom in many ways. Another major change in the last 8 years has been the growth of internet and social media. You no longer need to place a Super bowl ad to generate buzz about your product; a well-planned social media campaign along with some viral videos could do the job. The cost of creating a positive public opinion for a potential product is a lot lower now and can be hugely beneficial as was shown for the female libido drug, Addyi. Altogether, it is but natural that the approval rate of products has gone up. This news should be comforting to the developers as it shows that if your strategy is good, you communications with FDA are good, and you manage the public perception regarding your product well, you are likely to get your product approved. Even better news that there are many good training programs available on all these topics to get even the most novice companies become experts in a short time. This trend is expected to stay.