What Regulatory Changes Do We Need to Make to Improve New Drug Development?

Read Transcript

We need 21st century solutions for almost everything. And I say we need to go from best practice to next practice. So, for example, I was at a meeting, at the World Economic Forum in Davos two weeks ago, with the head of our pharmaceutical group, our Chief Scientific Officer, Paul Staples, was there with Peggy Hamburg on a panel, and also with Jeff Ryerson[sp?], Medical Journal Medicine Editor, and Minister of Health for Nigeria, and we spoke quite a bit in that panel about what are the challenges of getting drugs to market.

Now, if you have a new diabetes drug, you need to test it on hundreds of thousands of people, it could take $1billion and that's frankly where Johnson & Johnson is with a new diabetes drug that's been through the first FDA Advisory Committee. At the same time, they spoke about tuberculosis drug that Johnson & Johnson just brought to market, which is the first drug with the new mechanism of action in 4 years, and it was brought to market with less trails because of the huge unmet need, and the necessity to have a drug for multiple drug resistant tuberculosis. And the FDA Commissioner, Peggy Hamburg spoke that, there're a lot of ways that they can look and speed up the process if they are on that needs, and priority review, or fast review, or this pieces of E coli.

The same time, Medical Journal Medicine Editor, Jeff Traison[sp?] was saying, yes, it's so important that redo this, but we want to make sure we have incremental innovation or innovation that's going to better than the next one, and because the challenges are so huge, to bring up diabetes drugs it may cost 1 billion, and a tuberculosis drug, it still is over hundreds of millions of dollars. To bring to market effectively, there needs to be some incentives, and the discussion came forward and continues to be on what are the incentives that we can give.

If you make a song or a video game, you get 75 year copyright, you make a drug, you get 20 years from the time you first registered, and that could take 10 years to get it to market. So for a very short period, if we just figured out a way either one to make the period longer, so we're paying for it in the back end, or a way to basically send someone sent up on the front end of drug with high on that need, I think we'd have a huge opportunity to make a difference.