There are articles and blogs in the media about pharmaceutical companies and the drought in innovative products that has hit the industry since 2004, but that certainly wasn’t the case in 2014. On January 14, 2015, Dr. John Jenkins, Director of the Office of New Drugs at the FDA, issued a post that the agency had approved forty-one novel new drugs last year, the most in almost 20 years. Just a few days earlier, on January 9, the EMA issued a press release saying in 2014 it had recommended the highest number of orphan designated medicines for marketing authorization in a year.
On all fronts, 2014 was a strong year for drug approvals in the United States, with a total of forty-four drugs winning FDA approval, which Forbes notes is the most in 18 years.
So, what has changed?
Communicate and Collaborate
To start with, communication with the agencies is significantly better. Companies now get to work with the regulators pre-IND, whereas in the past – at least pre-PDUFA – you just submitted and hoped you would get approval, and that could take years.
Collaboration is another important factor. Companies are working with one another, with academia, with CROs, with service providers like CSC. And as they work with those partners, they’re putting a lot more thought, time, and effort into planning and strategy. That means that by the time they’re ready to submit, all the necessary studies have been completed, and there has been open communication with the agencies during the entire development process. That means unless there are safety issues, there shouldn’t be any surprises with the content of the marketing application.
A third aspect to the speed of approval is that there’s just so much more information to draw on. Thanks to the internet and the availability of key information from public bodies such as the NIH, companies are able to develop innovative drugs using better technology and more advanced techniques.
On top of all this, there are more incentives for companies to develop breakthrough therapies and drugs for rare diseases. Much of this has resulted from advocacy groups pushing for more research to be done into rare diseases and regulators responding to this push by offering faster approval, patent extensions, and so forth. In fact, seventeen of the forty-one novel new drugs approved by the FDA were for rare diseases designated as Orphan Drugs. Perhaps even more excitingly, seventeen were identified as first-in-class, using a new and unique mechanism of action for treating a medical condition.
Solutions and Services Making the Difference
Technology advances and high-quality service offerings are also making a remarkable difference. For example, our FirstDoc solution helps companies create, review, and approve and their critical content in a secure, controlled environment. Our TRS Tracker helps companies track and manage regulatory authority applications, submissions, and approvals globally. In addition, CSC’s services team helps companies prepare and submit their applications more efficiently to the health authorities. Simply having the ability to rely on software and services vendors makes a significant difference, allowing companies to focus on the drug development strategy. Our wealth of experience in the life sciences, which we’ve incorporated into our software and services, means we’re in a position to deliver out-of-the-box best practice-based systems to reduce cycle times and improve overall information management.
The approval of so many new drugs is excellent news for the industry, but most importantly it is life-changing for many patients in need.