Camargo was one of the sponsors of Cambridge Healthtech Institute’s Drug Repositioning Summit last week (Oct. 6-7, 2008). I woke the group up on the second day with a breakfast talk entitled “505(b)(2) Experiences – The Journey Continues”. I reviewed some of the important changes over the last few years that the FDA has made in its approaches to 505(b)(2). Clearly, FDA isn’t following the 1999 Guidance. Some highlights:
– Pre-IND meetings:FDA isn’t following its own regulations. Pre-IND meetings are being denied, adversely affecting many development projects.
– DESI Products: A huge source of potential 505(b)(2) products, FDA came down hard on DESI producers to file and IND or risk losing their product.
– PREA: November 2007 saw teeth put into pediatric development – all new NDA’s or supplements must have a pediatric assessment and likely require pediatric studies as a condition of approval; fewer deferrals are likely.
– FDA Divisions Divided: No secret that FDA Divisions regulate 505(b)(2)’s differently. You need frequent meetings to find out how each Division is working.
– Stability Data: The NDA filing requirement is 3 batches for 12 months at room temperature (RT) and 6 months at elevated temperature and humidity. We have seen plenty of applications filed with only 6 months RT and submission of the rest of the 6 months during review. Now FDA is pushing back, saying that they may not have the manpower to review the additional 6 months data, effectively approving a product with just 6 months shelf life.
– Development Targets: We have seem a move away from simple products (salt, Pk-only) to more complex (combination, pro-drugs, new indications).
I offered some views about the future. A presentation at the Summit by a former colleague Art Pappas of Pappas Ventures noted that 43% of the new drugs approved in fiscal year 2007 were 505(b)(2)’s, up from less than 20% the year before. At Camargo we are involved with 4-7 IND’s per month. With FDA already reducing pre-IND meetings and pushing back on stability data due to manpower, we can imagine that FDA’ new drug divisions will have trouble coping with the 505(b)(2) influx. PDUFA allows many of the first 505(b)(2) applications to be free. We have a potential log jamb ahead of us.